Senior Validation Engineer
S
Syner-GBiopharmaceutical
Fully remote work options for most positions and the ability to work “almost anywhere.”Full-TimeSenior
Salary$120,000 to $140,000 yearly
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Job Details
- Experience
- 7–11 years
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 7–11 years of commissioning, qualification, validation, or engineering experience in regulated life sciences industries.
- Strong understanding of FDA cGMP requirements and GDP documentation practices.
- Experience with risk-based commissioning and qualification methodologies.
- Experience executing or supporting IQ, OQ, PQ, commissioning, startup, and functional testing.
- Ability to review P&IDs, specifications, and turnover packages.
- Familiarity with deviation management, change control, and quality systems.
- Strong attention to detail and documentation accuracy.
- Proficient with Microsoft Office and electronic quality/documentation systems.
Responsibilities
- Review approved design, vendor, turnover, and qualification documentation.
- Support system walkdowns, field verification, and readiness assessments.
- Execute commissioning and qualification protocols, including IQ, OQ, PQ, and functional testing.
- Verify installation and functionality of equipment, utilities, and automation systems.
- Coordinate testing activities across Engineering, Automation, Quality, and vendors.
- Document discrepancies, protocol exceptions, and deviations for resolution.
- Perform protocol data review for compliance with GMP requirements.
- Develop qualification summary reports and system closeout packages.
- Support system handover to Operations and Quality stakeholders.
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