Job Description
Senior Validation Engineer
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Position Summary
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We are seeking a hands-on Senior Validation Engineer to lead the planning, development, execution, and lifecycle maintenance of equipment and process validation activities within a regulated manufacturing environment. This position will support manufacturing processes and equipment, lead IQ/OQ/PQ activities, collaborate with cross-functional teams, and drive continuous improvement through data-driven problem solving.
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Key Responsibilities
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- Lead validation activities for manufacturing processes, equipment, and supporting systems.
- Develop and execute validation documentation, including Validation Plans, URS, risk assessments, IQ/OQ/PQ protocols and reports.
- Coordinate shop-floor execution of validation protocols, including resources, sampling, instrumentation, and testing.
- Establish and evaluate critical process parameters, control limits, and process capability using DOE, MSA, SPC, and capability analysis.
- Analyze manufacturing and validation data to identify trends and opportunities for improvement.
- Lead root cause investigations, CAPA activities, and process improvement initiatives.
- Support equipment qualifications, process changes, equipment transfers, and engineering changes while maintaining the validated state.
- Partner with Manufacturing, Quality, Engineering, and other cross-functional teams on validation and process improvement activities.
- Support improvements to quality systems, procedures, work instructions, and validation workflows.
- Ensure appropriate data integrity and documentation practices within computerized systems.
- Provide technical guidance and mentorship to engineers and technicians on validation practices, documentation, and statistical methods.
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Qualifications
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- Bachelor's degree in Engineering, such as Mechanical, Manufacturing, Industrial, Biomedical, or a related field.
- 6+ years of validation experience within a regulated manufacturing environment such as medical device, pharmaceutical, or combination products.
- Strong experience with IQ/OQ/PQ and validation lifecycle activities.
- Knowledge of cGMP, ISO 13485, 21 CFR 820, and Part 11; familiarity with GAMP 5 and risk-based validation is preferred.
- Experience developing sampling strategies, acceptance criteria, and validation test methods.
- Strong understanding of DOE, MSA/Gage R&R, SPC, and process capability analysis.
- Experience using Minitab or similar statistical software.
- Strong technical writing, documentation, and data integrity skills.
- Experience with process/equipment qualifications, automated manufacturing, or cleanroom environments is preferred.
- Strong communication skills with the ability to work effectively across cross-functional teams.
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Work Environment: This is an on-site position supporting manufacturing and validation activities directly on the production floor.