Main Responsibilities and Required Skills for Validation Engineer
A Validation Engineer is responsible for developing, executing, and overseeing validation plans. They review process validation protocols and develop written procedures for calibration and preventive maintenance of equipment and instrumentation. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Validation Engineers.
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Main Responsibilities of Validation Engineer
The following list describes the typical responsibilities of a Validation Engineer:
Adhere to
Adhere to a high level of professionalism by demonstrating ethical behaviour.
Adhere to company policies.
Analyze
Analyze and interpret resulting data from tests (resolve data anomalies).
Assist with
Assist in development, maintenance, and reporting of department metrics.
Assist with audits for validation / qualification.
Assist with software, automated systems and controls validation.
Assist with troubleshooting and effectively resolving problems.
Assure
Assure that the validation program is compliant with global, site and industry practices.
Author
Author or update Validation SOPs.
Author qualification reports for executed protocols.
Author, review, and / or edit validation documents to support regulatory filings.
Author, review, and approve investigational and / or technical study protocols and reports.
Author, review, and approve process development / process validation protocols and reports.
Build
Build and deploy kernel from source a bonus.
Certify
Certify environmental monitoring / recording devices.
Coach
Coach and mentor colleagues as required in the ASV discipline and document key tacit knowledge.
Collaborate with
Collaborate with developers of each subsystem with system design and code reviews.
Collaborate with matrix organization to optimize Change Control implementation and management.
Collaborate with Software Team Leader and Software Quality Assurance in verifying test results.
Collaborate with vendors to improve product quality.
Communicate
Communicate with OEM and suppliers for systems and components validation.
Complete
Complete internal and external Audit findings as assigned.
Complete Qualification and periodic mapping of process equipment, fridges and freezers.
Complete understanding of all loan regulations, rules, and requirements.
Conduct
Conduct FAT, IQ, OQ and PQ qualifications for molds and / or equipment and molding processes.
Conduct quarterly verification tests Schedule.
Contribute to
Contribute to the improvement through usage and feedback of the diagnostic service tool.
Coordinate
Coordinate contract personnel through completion of assignments.
Coordinate multiple tasks simultaneously.
Coordinate, perform and support verification activities.
Coordinate validation activities performed by each validation actors.
Create
Create and execute test procedures to validate the design of various GPU components and features.
Create and revise Device Master Record documents.
Cultivate
Cultivate internal and external network of resources to complete tasks.
Debug
Debug and drive root-cause analysis for Security related issues.
Debug complex system level hardware and software.
Debug issues found during pre-silicon, bring-up, validation, and production phases of SOC programs.
Define
Define metrics, interfaces and develop testing methods for subsystems and components.
Design
Design and develop test protocols for new and advanced features.
Design and support the execution of Aseptic Process Simulations in RABS and isolators.
Design test verification plans, procedures and test reports of all product features.
Determine
Determine requirements for new test equipment and / or redesign of existing test equipment.
Develop
Develop and maintain keen understanding of internal and external customers' need.
Develop and support continuous improvement initiatives.
Develop post-silicon validation infrastructure (Software, Hardware, Automation, and lab setup).
Develop scenarios to give management a set of viable alternatives.
Develop strategies to ensure client systems remain "audit-ready”.
Develop testing documentation.
Develop Validation plans as required for the projects.
Develop validation plans for small to medium sized validation projects and write.
Develop written procedures for calibration and preventive maintenance of equipment.
Direct
Direct the efforts of others such as technicians and outside resources.
Document
Document and Update Product / Process Knowledge.
Document results with detailed technical reports.
Draw
Draw insights from projects and supplemental research to help drive new and existing growth.
Drive
Drive development of system-level validation software.
Drive process risk management activities.
Ensure
Ensure adherence to Cybersecurity guidelines.
Ensure all Configuration and Change Management (CM) processes are properly followed.
Ensure all product issues are identified, logged, tracked and resolved during each testing phase.
Ensure customer sampling and key deliverables are met.
Ensure documentation is complete and meets defined requirements.
Ensure functional correctness, electrical compliance / margins, and customer use case enablement.
Ensure that recommendations are addressed and applicable actions completed.
Ensure that the developed solution meets the requirements and can operate in the environment needed.
Evaluate
Evaluate appropriateness of action / alert levels.
Execute
Execute and oversee the Automated Systems Validation activities.
Execute test cases in a lab environment and where applicable within the vehicles.
Execute test procedures both personally and using test technicians.
Facilitate
Facilitate communication between engineering function, manufacturing, and quality.
Facilitate the Risk Management (FMEA) sessions for capital projects.
Follow
Follow all Environmental, Health and Safety Rules and Regulations in the plant.
Follow established procedures.
Generate
Generate documentation and SOPs associated with each of the automated systems.
Generate scope and provide and realistic estimates (both time and effort) for the requested tasks.
Generate validation studies during regulatory inspections and internal audits.
Guide
Guide and participate in testing, identification, and problem solving.
Identify
Identify and address any potential quality impact throughout the project.
Identify and propose remediation for existing and potential validation issues.
Identify exceptions associated with validation protocol execution.
Implement
Implement system modifications under cGMP change control.
Initiate
Initiate and enforce necessary improvements and corrections.
Initiate, execute, and track completion of Change Control requests.
Lead
Lead and document investigations of failed validation test results.
Lead automation efforts to streamline test flows and maximize resource efficiencies.
Lead Export validation activities in foreign countries with local partners.
Lead / Participate in external audits of providers and labs.
Lead testing of new electronics components, software, systems and solutions.
Lead trouble shooting activities for deviations and non-conformances.
Lead utilization of quantitative risk assessments in validation and project planning.
Log
Log defects and issues found during V&V activities and track to closure.
Maintain
Maintain a working familiarity with current industry best practices and cGMP requirements.
Maintain basic laboratory organization and cleanliness.
Maintain documentation of test results to assist in debugging and modification of software.
Maintain frequent communication with customers.
Maintain sterility validations.
Maintain the validated state of the automated systems.
Maintain up to date knowledge of validation requirements, practices and procedures.
Make
Make improvements to system level validation test strategy, methodology, and process.
Make technical recommendations regarding materials qualification projects.
Manage
Manage contractors performing equipment and system qualifications.
Manage projects, identify areas of improvement, and support safety working practices.
Manage projects of varying scope and complexity.
Mentor
Mentor and coach diverse team on validation, quality and compliance.
Nurture
Nurture relationships with third-party software vendors.
Operate
Operate using independent judgement and discretion with little oversight.
Oversee
Oversee and assist Associate Engineers and / or Technicians with their assigned projects.
Oversee and manage validation instrument inventory including calibrations.
Participate in
Participate and / or lead discussions with internal, customer and regulatory agencies.
Participate in change control reviews.
Participate in client audits if needed.
Participate in defining / improving / executing test plans / procedures.
Participate in design reviews along with Internal and Customer engineering.
Participate in determining goals and objectives for projects.
Participate in issuing internal / external releasable test reports.
Participate in product failure investigations.
Participate in software peer reviews together with SWQA for the assigned projects.
Participate in the generation and / or update of the validation plan and validation status lists.
Perform
Perform as a program validation lead starting pre-silicon through post-silicon milestones.
Perform basic debug of the systems to assist in the problem identification and resolution.
Perform electrical measurements of the board level signaling environment.
Perform Failure and Hazard Analysis, create and maintain a Hazard log.
Perform Failure Modes and Effects Analysis (FMEA) on proposed concept designs.
Perform occasional moderate lifting.
Perform product validation and analysis.
Perform regression analysis and determine testing associated with design changes.
Perform root-cause analysis and identifies appropriate, effective corrective actions.
Perform Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
Perform validation review and support for pilot plant campaign and master cell bank readiness plans.
Prepare
Prepare and execute process validation protocols (new and existing clients) and writing reports.
Prepare Equipment and Process validation protocols according to internal and external requirements.
Prepare test data sets and go execute tests.
Prepare written communication.
Provide
Provide audit support to internal and external audits.
Provide daily Engineering support for validated equipment and instrumentation.
Provide guidance on design and methodology for future products based on findings found in the lab.
Provide immediate troubleshooting and manufacturing support during manufacturing operations.
Provide regular updates to internal team on validation progress.
Provide schematic and layout reviews on next generation board designs.
Provide technical design / identification / debugging support towards production.
Provide technical expertise and provide solutions to maintain compliance.
Provide technical guidance, coaching, and mentorship to other engineers in your areas of expertise.
Provide technical leadership with respect and integrity.
Read
Read and interpret drawings such as PFDs, P&IDs and electrical schematics.
Recommend
Recommend design changes to improve automated testing.
Recommend to management as to the acceptance and release of qualified systems.
Resolve
Resolve protocol discrepancies and deviations.
Review
Review Program / Process Results.
Review requirements and scrutinise for testability.
Review software specifications, designs and code to improve overall quality of automation.
Review SOPs for compliance.
Review vendor generated validation protocol packages.
Schedule
Schedule and coordinate validation activities with system owners and key stakeholders.
Seek
Seek opportunities to drive improved validation methodologies within the team.
Send
Send detailed reporting on regression validation regularly.
Supervise
Supervise internal / external resources as needed to support the labs.
Supervise vendors for qualification functions.
Support
Support all Process Validation activities.
Support development of validation execution strategy with external vendors and project team.
Support Engineering on testing control systems electronics.
Support engineers with automated test execution on multiple platforms.
Support guidance on test execution and HiL system usage for less experienced team members.
Support of maintenance of operation equipment.
Support post-production updates.
Support regulatory submissions and supplements notification.
Support to certification and acceptance.
Support to the procurement team in support of approach to market activities.
Support Validation COP meeting.
Synchronize
Synchronize with TAS-FR Project Manager, development team.
Take
Take lead role on new equipment validation.
Test
Test and quality assurance of automotive and energy storage lithium-ion battery packs.
Track
Track validation packages throughout the validation cycle.
Troubleshoot
Troubleshoot and debug issues found testing.
Understand
Understand NA / CA / EU safety and regulatory requirements and processes.
Understand the business cycle and foresight of emerging technologies trends.
Understand the competitive landscape of the pharmaceutical and biotechnology industry.
Update
Update documentation as needed as test cases are automated or updated.
Use
Use and understanding of SAP system.
Verify
Verify all requirement from clause by clause.
Verify the Engineering process applied to the solutions.
Work with
Work with cross-functional teams to Debug IP failures to deliver products to market with quality.
Write
Write and revise SOPs and Master Plans biennially or as part of process improvements.
Write deviations associated with protocol execution and work with team of engineers to resolve.
Write qualification / validation protocols, execute protocols and author reports.
Write validation final reports that offer conclusions based on test results.
Write validation test plans and checklists.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Validation Engineer:
Validation engineering
Computer Engineering
Debug
Technical Writing
FDA
Pharmaceutical
Biotechnology
Documentation Practices
Most In-demand Soft Skills
The following list describes the most required soft skills of a Validation Engineer:
Written and oral communication skills
Interpersonal skills
Organizational capacity
Problem-solving attitude
Analytical ability
Leadership
Adaptable to changes
Work independently with little direction
Highly motivated
Team player
Organized
Work in a team environment
Self-motivated
Teamwork
Self-starter
Attention to detail
Collaborative
Strategic thinker
Can translate client needs into actionable value-added projects / results
Curious
