Main Responsibilities and Required Skills for Process Engineer
A Process Engineer ensures that everything in the factory or office functions properly, including all of the machines, tools, and workers needed to produce the product. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Process Engineers.
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Main Responsibilities of Process Engineer
The following list describes the typical responsibilities of a Process Engineer:
Administer
Administer critical analysis of test results and deliver solutions to problem areas.
Analyse
Analyse tool and process data for continuous improvement.
Analyze and disposition non-conforming material or processes.
Analyze large, complex data sets using spreadsheets and / or other data analysis packages.
Analyze business solutions and provides comprehensive reports and recommendations.
Analyze equipment specifications and performance requirements to determine appropriate designs.
Analyze solution costs and benefits and optimize system and equipment design.
Analyze proposals to determine viability, operational impact and return on investment.
Anticipate
Anticipate potential problems and use critical thinking skills to identify and eliminate root causes.
Assist in / Assist with
Assist in developing P.F.M.E.A. / F.M.E.A. / P.C.P / and P.F.D's.
Assist in equipment selection, testing, procurement and commissioning support.
Assist in equipment troubleshooting activities as needed.
Assist in incoming and outgoing file transfers.
Assist in mentoring of less experienced engineers.
Assist in part design reviews with an eye for good manufacturing process DFMEA.
Assist in the development of execution strategy, including procurement.
Assist in the development of manufacturing execution system strategy, road mapping, and KPI's.
Assist in the development of routings.
Assist manufacturing and R& D in developing and processing new and existing items.
Assist Production and Quality Management with SOP development, revision, and training.
Assist production troubleshoot day-to-day equipment, material, or process issues or concerns.
Assist the Health & Safety team in the design and implementation of ergonomic projects.
Assist with Air Emissions Calculations for compliance to Air Permit.
Assist with cost and manpower estimates.
Assist with the creation of local SOPs and protocol templates.
Author
Author and execute IQ / OQ protocols.
Author regulatory filings across product lifecycle.
Build
Build and maintain computers and the computer network for the plant manufacturing systems.
Build meaningful and productive relationships with internal business partners.
Change
Change control prioritization and implementation.
Change control procedures will need to be developed, approved and followed.
Collaborate with
Collaborate with diverse teams locally and globally.
Collaborate with process, mechanical, application, sales and consulting engineers.
Communicate
Communicate decisions, results, and challenges with colleagues of varying technical backgrounds.
Communicate effectively at all organisation levels with.
Complete
Complete administrative tasks correctly and on time.
Complete closed job reviews to translate lessons learned.
Complete employee benefits (RRSP, group insurance).
Complete value stream mapping and process optimization studies.
Conduct
Conduct alternate piece parts qualifications.
Conduct audits on new processes and procedures.
Conduct lab testing as needed for development of process guarantees or plant troubleshooting.
Conduct quality investigations and determine CAPAs.
Conduct regular compliance check-ins with cross functional business partners.
Conduct risk assessment for non-routine tasks (if any) to prevent accident / incident.
Conduct talent performance reviews bi-annually with monthly touchpoints at a minimum.
Contribute
Contribute ideas for improving work processes and achieving organizational goals.
Contribute to building a positive team spirit.
Contribute to problem-solving, can establish standards, and committed to improvement.
Contribute to the specification, installation and running of new bioprocessing equipment.
Coordinate
Coordinate a collaborative testing process between the business and IS team members.
Coordinate activities with maintenance to resolve mechanical issues.
Coordinate and or cooperate with other members related to push continuous improvement.
Coordinate continuous improvement initiatives.
Create
Create and execute process enhancement, and new process development plans as assigned.
Create and execute Quality System records to ensure equipment performance history is.
Create and maintain KPIs for manufacturing to monitor progress and changes in output or quality.
Create and / or actively participates in the review process of 3D models of the equipment.
Create and revise cost standards.
Create investigation and research plans to fit overall project objectives.
Create, Review and Approve Plant Change Requests (PCR's).
Cross functional exposure to other areas of Quality and Production.
Define
Define relevant operational / technical standards and best practices for manufacturing sites.
Design
Design and develop digital tools to streamline process review and increase efficiency of the BDMC.
Design and innovate work processes to meet all key requirements.
Design fixtures, tooling and robotic systems using SOLIDWORKS CAD software.
Design methods to increase process efficiencies, cost, yield, and quality.
Develop
Develop and contributes to the implementation of capital projects.
Develop and document procedures for control of equipment, processes and systems.
Develop and implement data analysis techniques to support manufacturing intelligence.
Develop and maintain instructions and standard operating procedures for production operators.
Develop and maintain quality control for capital and non-capital projects.
Develop and maintains a library of such documentation.
Develop and manage the integration of SCADA systems.
Develop and review optical thin film deposition processes to meet requirements and specifications.
Develop and Write structured Engineering memos in support of investigation closures.
Develop / assemble construction specifications for piping and mechanical.
Develop business cases for potential optimization opportunities and review with senior leaders.
Develop Business unit BPM Maturity targets & Road map.
Develop controls description and P&ID's for plant operation.
Develop countermeasures to prevent problems during on-floor implementation of equipment solutions.
Develop design schedules and monitor various projects' progress.
Develop / edit equipment preventative maintenance procedures.
Develop equipment and processes that meet safety codes, polices, and guidelines.
Develop Equipment Lock Out Tag Out procedures.
Develop expert processing equipment.
Develop fixture design concepts to support new and existing processes.
Develop forecasting models for processed data.
Develop his / her business network.
Develop, implement and monitor robust preventive measures for processing issues.
Develop innovative solutions.
Develop into a technical expert for our processes.
Develop manufacturing processes for cell therapy products.
Develop measurement designs and controls for critical equipment processes.
Develop methods for Raw Materials, Finished Products.
Develop new criteria / calculations where required, maintaining high levels of accuracy.
Develop operations and technical documents.
Develop processes to minimize risks to product.
Develop process simulation and hydraulic models.
Develop, run and report Apheresis metrics and KPI in stakeholder meetings.
Develop Standard Operating Procedures (SOP).
Direct
Direct activities of process and quality control personnel.
Direct the efforts of others such as technicians and outside resources.
Direct the activities of these third-party resources to ensure equipment operates as intended.
Document
Document and evaluate data using Main tab, Excel and CAD.
Document project outcomes.
Document test protocols in accordance with Align QMS and FDA regulations.
Drive
Drive business awareness of quality / process methodology.
Drive complex defect elimination.
Ensure
Ensure adherence to GMP and safety procedures.
Ensure all equipment installed is safe, effective and in compliance with industry standards.
Ensure compliance of all manufacturing facilities to agreed standard operating procedures.
Ensure compliance with regulatory requirements.
Ensure effective relationships among the design team (s) and partners.
Ensure equipment requirements can meet processing needs.
Ensure financial budgets are followed throughout the manufacturing process.
Ensure safe working procedures and the implementation there of for all works.
Ensure site compliance with corporate process standards.
Ensure that deliverables conform to our company standards and practices, and are technically sound.
Ensure that mechanistic and statistical modelling work packages are delivered to.
Ensure that quality, health and safety, and environmental requirements are met.
Ensure the maintenance of a clean and safe working environment.
Ensure the technical support for the Change Control system implemented between company and the sub.
Ensure weekly and monthly reports are completed in a timely manner to support improvement.
Establish
Establish and control project spending to budget by specifying and estimating project costs.
Establish contacts regularly with stake.
Establish design schedules and monitor progress of various projects.
Establish open lines of communication.
Establish, translate, and execute the short-term policy for the supply chain process.
Establish robust, repeatable and reproducible process parameters.
Evaluate
Evaluate and approve all change requests globally, related to area of expertise.
Evaluate current welding procedures and make recommendations for improvements.
Evaluate Materials of Construction.
Evaluate new product of processes for appropriate 'lean' application.
Evaluate Process Alternatives and Equipment / Technology Selection.
Evaluate process and design alternatives based on "Design for Manufacturability” principles.
Evaluate internal control systems and recommends improvements in controls.
Evaluate process and design alternatives based on "design for manufacturability” principles.
Facilitate
Facilitate sessions and apply design principals to develop future state processes.
Facilitate strategy meetings.
Facilitate the deployment of new and changed processes to provide improved results.
Facilitate the creation and maintenance of proper product documentation.
Facilitate the development of a healthy cross-functional group of qualified lean tool experts.
Formulate detailed plans for execution by other less experienced engineers.
Gather
Gather information, develop and evaluate alternatives, and prepare engineering reports.
Gather and analyze data and metrics to evaluate and report on current operations and processes.
Generate
Generate Production assembly travellers.
Generate project ideas and solutions.
Generate supplemental aids for production using Visio software.
Identify
Identify full range of customer needs and proposes solutions to address them.
Identify the process requirements and implements the identified solution.
Identify complex technical issues to determine root cause.
Identify root-cause of failures through experimentation (DOE's) and historical data analysis.
Identify, scope and manage process test work (on site or laboratory based).
Implement
Implement and manage resource planning and project management tools.
Implement Global Biologics Engineering design standards.
Implement, modify, and maintain chemical processes.
Implement process monitoring in accordance with division procedures.
Improve
Improve and adjust product formulations to make them compatible with bigger production runs.
Improve cost performance of processes / equipment.
Improve Foundry Process including quality, production, and equipment issues.
Improve process ability that benefits the internal and external customer.
Incorporate
Incorporate feedback from Operations and Plant Science R& D teams.
Incorporate business policies and procedures into task completion.
Insure
Insure all molding systems operate effectively to support plant production.
Insure full technical project execution (studies, construction, commissioning).
Integrate
Integrate improvements on a continuous basis.
Integrate vertical and may integrate horizontal solutions into the strategy.
Interpret
Interpret project technical specifications.
Interpret and post metrics that shows the team's performance.
Keep up-to-date with
Keep up-to-date with industry standards and technology related to the metallurgical industry.
Lead
Lead and / or participate on teams with safety, technical, management, and other team members.
Lead development and implementation of Process Health Management System.
Leader that extensive experience with gummy manufacturing.
Lead implementation of process improvement projects.
Lead projects related to process improvements and equipment installations.
Lead and participates in design, planning and introduction of Packaging production lines.
Lead by example with impeccable GMP and PPE adherence.
Lead the execution of Williamsburg's waste and scrap reduction initiative.
Lead the implementation of manufacturing processes.
Liaise with
Liaise with and provide efficient and timely support with any process issues that arise.
Liaise with vendors on procurement activities, defining purchase criteria and process qualification.
Maintain
Maintain and develop technical skills.
Maintain and monitor adherence to these control documents.
Maintain a precise and accurate level of instrumentation.
Maintain a safe and professional work environment.
Maintain digital infrastructure and report any outages.
Maintain individual Performance Management Documentation with manager.
Maintain job records as required.
Maintain relationships with contractors and equipment suppliers and service staffs.
Maintain strong working relationships in a collaborative, fast-paced, goal-driven environment.
Maintain the highest degree of honesty and integrity at all times.
Manage
Manage capital projects to select, design, procure, install and qualify new manufacturing equipment.
Manage contractors to execute project tasks as appropriate.
Manage cost and time constraints.
Manage department budget and related expenses.
Manage employee departures by providing the necessary information to the parties involved.
Manage engineering changes for trial requests.
Manage material requests (procurement and movement) with Inventory Management.
Manage multiple projects together.
Manage process projects for quality development of III-V based infrared focal plane arrays.
Manage shift support to operations.
Manage sourcing, justification and implementation of capital equipment projects.
Manage the execution of bench scale assays and proof-of-concept experiments.
Mentor
Mentor and train junior colleagues.
Mentor junior engineers and support them in their development.
Monitor
Monitor and evaluate project and department progress and results.
Monitor and support post-process unit operation processes.
Monitor batch process per operating instruction through DeltaV Control system.
Monitor batch to batch variability to make continuous improvement in upcoming production activities.
Monitor daily process variables.
Monitor Sales' and Consumer Services feedback on quality concerns and trends.
Monitor all costs associated with assigned organizational unit.
Monitor work for compliance to applicable codes and accepted engineering practices and standards.
Optimize
Optimize and offer design solutions during concept selection and design.
Optimize product slotting and fulfillment productivity.
Oversee
Oversee / participate in projects as needed in order to support Cresilon's business objectives.
Participate in
Participate in a sampling of L1 Self Inspections for the area (s) of responsibility.
Participate in continuous improvement by streamlining and implementing new processes.
Participate in continuous improvement committees.
Participate in design and HAZOP reviews as required.
Participate in engineering and construction reviews.
Participate in HAZOPs and close out action items.
Participate in HAZOPs, PHAs, model reviews, and performance tests.
Participate in long term strategic planning involving the optimum utilization of company assets.
Participate in ongoing cost reduction programs.
Participate in our Plant Safety programs and offers suggestions to eliminate safety concerns.
Participate in pilot plant campaigns, plant start-ups and plant audits.
Participate in Plant internal Process audit.
Participate in proactive team efforts to achieve program and company goals.
Participate in the day-to-day process improvement activities.
Participate in the development of capital budgets.
Participate in the work order request & approval process.
Participate on new product development teams as it pertains to their plant.
Participate to Production Support when requested.
Perform
Perform analyses to develop design specifications and performance requirements.
Perform and document Risk Assessments.
Perform appropriate reviews with stakeholders.
Perform a robust situation assessment, document manufacturing methods, and procedures.
Perform commissioning of process and mechanical systems and participate in FATs and SATs.
Perform design and sizing of natural gas dehydration and separation systems.
Perform equipment and process characterizations and qualifications (IQ / OQ / PQ).
Perform equipment and process qualification activities to support GMP production.
Perform literature searches & document reviews.
Perform necessary assessments of aseptic operation and update necessary documents.
Perform optimization tests.
Perform or support periodic equipment reviews, including access audit trail reviews.
Perform other duties as assigned by leadership.
Perform other responsibilities to support group, site and network-based initiatives, as required.
Perform root-cause analysis and identifies appropriate, effective corrective actions.
Perform tasks that regularly require good correctable vision and hand / eye coordination.
Perform triennial reviews of SOPs as appropriate.
Plan
Plan and conduct small-sized projects.
Plan and organize non-routine tasks w / approval.
Plan, schedule, and control the work with respect to quality, productivity and budgets.
Prepare
Prepare and implement unit budgets and schedules.
Prepare and / or review design documents for Nuclear Power Plants.
Prepare appropriation requests for capital investments.
Prepare equipment speficiations and datasheets.
Prepare reports on material, product, or equipment performance for internal and external customers.
Prepare and presents plans and coordinates deployment.
Prepare written communication.
Prepare technical and economic assessments.
Prepare technical specifications, datasheets and calculations for process plant and equipment.
Prioritize
Prioritize and schedule project process staff work.
Process
Process and ensure right finish product quality.
Process control design related to mechanical systems.
Process Design (5 years of experience is required).
Process development experience utilizing DOE, SPC, DFX, FMEA, Gage R&R and qualification standards.
Process development programme design / plant trials, execution and implementation.
Process development, scale-up, control, and documentation of catalyst slurry mixing process.
Process documentation, data analysis, and data report certification / quality assurance of data.
Process Engineering, Intern.
Process Engineering Technologist Packaging and Inspection.
Process Engineering & Validation.
Process expertise in preparing root cause analyses for any non-conformities.
Process Improvement, Lean, Mechanical Engineering or Industrial Engineering.
Process line sizing calculations.
Process map review, potenital updates and / or creation.
Process, New Materials Development.
Process / Project Design including but not excluding.
Process, storage, throughput & productivity optimization.
Produce
Produce block flow diagrams, PFDs, P&IDs and Layout drawings.
Produce project deliverables on-time and on-budget.
Propose
Propose and implement optimisation project to improve performance, quality, and compliance.
Propose capital based projects for improvement, safety, quality and other initiatives.
Propose line upgrades to address efficiency, obsolescence, compliance and safety risks.
Provide
Provide assistance and support to Operations during commissioning and start-up.
Provide assistance to plant technical manager on assigned projects.
Provide assistance with budgeting and forecasting.
Provide continuous development of manufacturing techniques that will improve in-house capabilities.
Provide daily mechanical engineering support to production.
Provide design solutions for System, Structure and Component modifications.
Provide, document and control machine parameter setups.
Provide E-Beam training and guidance to applicable operators and technicians.
Provide education and training to the operations team for better understanding of the process.
Provide field evaluations and recommends operation or maintenance modifications.
Provide input on potential candidates to be hired into the team.
Provide internal / external audit support.
Provide leadership and guidance through efficiency and process optimization.
Provide manufacturing support to new product introductions and in-sourcing products.
Provide plant leadership for manufacturing control strategies and process improvement plans.
Provide Project Management report outs through effective communication of verbal and written reports.
Provide review and input to C&Q strategy and participate in testing of equipment.
Provide supervisory and technical assistance for any onsite commissioning work.
Provide support for training and certification of Production Technicians.
Provide support to the production line for troubleshooting.
Provide sustaining engineering support and assist in continuous yield improvement exercises.
Provide technical advisory role to Plants.
Provide technical and operational support to meet internal and external customer requirements.
Provide technical leadership as a subject matter expert in multiple areas of responsibility.
Provide technical leadership to business units.
Provide technical risk assessments and justification documents.
Provide technical support and training to Operations and Maintenance.
Provide technical support for plant packaging operations as an area engineering representative.
Provide technical support to production, maintenance management, and technical personnel.
Provide technical training on process and equipment as required by Operations.
Provide the data to the ZBS-Packaging and ZQA, and adjust the process parameters.
Provide workable insights for product team to improve the products.
Provide written handover of issues at end of shift.
Research
Research and obtain assembly instruction, tooling and dimensional information.
Research and purchase new manufacturing technology.
Review
Review all complaints and manages complaint form responses.
Review and assess supplier change notifications.
Review and evaluate minor engineering changes and / or other specification requirements.
Review manufacturing processes and / or development and production data.
Review of capital cost estimate.
Review P&IDs and provide support as needed.
Review technical design and qualification specifications associated with ASTM E2500.
Seek
Seek opportunities to improve task safety, efficiency, and reduce cost.
Seek, recognize, define, and solve problems to achieve unit objectives.
Set
Set clearly defined goals / objectives to ensure delivery of high-quality results.
Set out ITPs and documentation packages for process and mechanical systems.
Share
Share best practices in tech transfer and implementation and drive continuously improvement.
Share operational and process learning with the rest of the manufacturing network.
Study
Study current production plant equipment for new model introduction.
Support
Support and provide guidance during plant upsets, shutdowns, and startups.
Support and write segments, as needed, for process specifications and process operation steps.
Support business development efforts as required.
Support coordination of assembly / construction work with subcontractors and vendors.
Support development of new processes and products.
Support development of production team members by acting as a technical resource.
Support equipment cross-qualification to ensure continuity and improve capacity and cycle time.
Support for development of the dynamic simulation tool (optional).
Support functions located at the facility.
Support installation, operational, and performance qualification activities.
Support investigations as required.
Support investigations, performance optimization and process improvement initiatives.
Support larger-scaled projects under the direction of more senior engineering staff members.
Support Lean Manufacturing, 6S projects, and initiatives.
Support Lean Manufacturing and 5S initiatives.
Support maintenance in complex trouble shootings and repairs.
Support of process development and equipment acquisition.
Support Operations Oracle and Quality Information System (QIS) transactions.
Support other site activities as required.
Support process development, commercialization, and optimization for meltspinning assets.
Support site and focus factory resources with process improvements.
Support the building of business case(s) for process improvement projects.
Support the development of new greenfield carbon capture and sequestration projects.
Support the development of new greenfield gas storage facility projects.
Support the evaluation and execution of minor and major capital projects.
Support the products during transfer to the CM and maintain the product in manufacture.
Support to maintain site specific safety goals, PASS and expectations.
Support Web Handling Process Engineering activities for capital asset expansions.
Track
Track metrics to discover areas for improvement and monitor upgrades.
Train
Train new engineers and test technicians on company processes and improvements.
Train operational, process, and quality staff on key engineering topics on an as needed basis.
Troubleshoot
Troubleshoot and address customer complaints and come up with corrective action plans.
Troubleshoot complex issues that arise on the machine.
Troubleshoot equipment and process problems and present solutions as processes scale.
Troubleshoot issues with drug product processing technologies and equipment.
Troubleshoots and problem solves analytical methods and instrumentation.
Understand
Understand IP issues relative to processes being developed.
Understand food processing.
Understand the manufacturing process, technologies, techniques and the product.
Update
Update and maintain Bills of Material and Part Routing Information.
Update and maintains "Yellow” Cost Sheets.
Use
Use of DMAIC principals to drive resolution of issues and drive improvement of supplier performance.
Use of microscopes and other precision measuring equipment.
Work with
Work will include walking throughout the manufacturing suite including up and down stairs.
Work with commodity managers and supply chain leads to identify key suppliers.
Work with cross functional teams to validate automated processes.
Work with internal departments on new project pilots with a transition into full scale production.
Work with local and national regulatory agencies.
Work with material representatives as required.
Work with peers and Process Engineers to develop maintenance and troubleshooting skills.
Work with production to outline allocation of resources throughout body.
Work with quality assurance and validation to assess validation requirements of equipment.
Work with quality to assure vendor conformance to objectives of the company.
Work with Regulatory teams to support product submissions to the FDA.
Work with the production teams to support the maintenance program.
Work with various computer software packages including specialist or bespoke computer systems.
Work with vendors to design and purchase production and test equipment.
Write
Write and revise standard operating procedures describing validation principles and activities.
Write protocols, reports, procedures, and memos as needed to support development and validation work.
Write technical protocols, reports, change controls, and investigations reports.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Process Engineer:
Chemical Engineering
Manufacturing
Project Management
Process Engineering
MS Excel
MS Word
Mechanical Engineering
Design
Process Improvement
MS Powerpoint
Biotechnology
Chemistry
Manufacturing Environment
Six Sigma
Business Acumen
Autocad
Pharmaceutical
Biopharmaceutical Process Development
Continuous Sitting For Prolonged Periods
Process Development
Industrial Engineering
Operations
Safety
Electrical
CGMP
Electrical Engineering
Continuous Improvement
Minitab
Physics
Lean Manufacturing
Outlook
SAP
Life Sciences
Engineering Discipline
Manufacturing Engineering
Microsoft Office
Quality
Statistical Process Control
Troubleshooting
Data Analysis
Most In-demand Soft Skills
The following list describes the most required soft skills of a Process Engineer:
Written and oral communication skills
Problem-solving attitude
Interpersonal skills
Leadership
Analytical ability
Organizational capacity
Attention to detail
Work independently with little direction
Flexible
Self-motivated
Initiative
Presentation
Teamwork
Time-management
Planning
Team player
Innovative
Collaborative
Self-starter
Detail-oriented
Multi-task
Accountable
Respect
Critical thinker
Organized
Ability to manage multiple tasks
Confident
Creative
Innovation
Integrity along with courage
Transparency
Decision-making
Delivering high quality results
Focusing on what matters
Overcoming challenges
Professional presentation
Troubleshooting skills
Bilingualism
Enjoy investigating complex problems
Making sense of information
