Sr. Validation Engineer
About The Position
The Sr. Validation Engineer independently leads validation of processes, equipment, utilities, and systems supporting sterile pharmaceutical production. The role develops scientifically justified validation approaches that meet current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and company procedures. Reporting to the Director of Validation, the position manages projects through the validation lifecycle, resolves complex technical issues, reviews validation deliverables, and mentors engineers. The position is based at Nivagen Pharmaceuticals Inc. in Sacramento, California. It involves work in cleanroom and sterile production areas with controlled environments and potential exposure to hazardous materials and chemicals used in pharmaceutical manufacturing. The employee must live or be willing to move to the Sacramento Metropolitan Region (approximately a 40-mile radius) and be willing to travel as needed to other manufacturing sites for vendor support. Nivagen is a nicotine-free campus, and nicotine products are prohibited on company property.
Requirements
- Bachelor's degree or diploma in pharmaceutical sciences, engineering, life sciences, or a related technical field.
- Minimum five years of pharmaceutical validation or commissioning and qualification experience, including direct experience in sterile manufacturing.
- Strong working knowledge of cGMP, applicable FDA and EMA requirements, relevant ISO standards, validation lifecycle principles, and data integrity expectations.
- Demonstrated experience independently leading equipment qualification and process validation projects, including protocol development, execution, technical review, and final reporting.
- Experience investigating deviations, assessing change controls, and supporting audits or inspections.
- Excellent technical writing skills and ability to communicate clear, scientifically justified conclusions.
- Strong analytical and troubleshooting skills, with attention to detail when reviewing data and complex technical documentation.
- Proficiency in Microsoft Word and Excel and familiarity with electronic systems for collecting, analyzing, and managing validation data.
- Strong understanding of aseptic processing, contamination control, and sterile manufacturing practices.
- Must live or be willing to move to the Sacramento Metropolitan Region (approximately a 40-mile radius).
- Willing to travel as needed to other manufacturing sites for vendor support.
Nice To Haves
- Cleaning validation experience is preferred.
Responsibilities
- Independently plan, author, execute, and technically review IQ, OQ, and PQ protocols for new and existing equipment and systems.
- Lead qualification of sterile manufacturing equipment, facilities, and utilities, including filling lines, isolators, autoclaves, terminal sterilizers, HVAC systems, and critical utilities.
- Define qualification scope, test methods, worst-case challenge conditions, and acceptance criteria based on intended use, technical requirements, and quality risk assessments.
- Perform and review thermal qualification and environmental mapping studies using Kaye validation systems, temperature and relative humidity data loggers, and calibrated test instruments.
- Author and technically review validation plans, user requirements, risk assessments, protocols, traceability matrices, and final reports, ensuring conclusions are supported by documented evidence.
- Verify raw data, calculations, test results, and resolution of discrepancies before recommending completed studies for approval; maintain accurate, complete, and traceable validation records.
- Develop and improve validation procedures and templates; perform periodic reviews and define requalification requirements to maintain the validated state.
- Lead assigned process performance qualification activities and support aseptic process simulations in collaboration with Production, Quality Control, Quality Assurance, and technical teams.
- Coordinate validation requirements for new products, process transfers, and equipment changes, including study design, sampling plans, and scientifically justified acceptance criteria.
- Support the development, execution, and technical review of cleaning validation and verification studies, including worst-case selection, sampling approaches, and evaluation of results against approved limits.
- Manage validation projects with Engineering, Operations, Quality, and vendors; establish schedules and resource needs, resolve technical issues, and communicate progress and risks to the Director of Validation.
- Lead validation-related deviation investigations, root cause analysis, impact assessments, and corrective and preventive actions through the site quality system.
- Assess change controls and performance trends for validation impact; define required qualification, revalidation, or supporting documentation and escalate quality concerns.
- Mentor validation engineers, technicians, and contractors; review their protocols and executed documentation for technical accuracy and completeness.
- Support audits and regulatory inspections by preparing validation records and explaining study rationale, results, and conclusions.
- Perform additional validation-related responsibilities as assigned by the Director of Validation.
Benefits
- Yearly bonus eligibility
- Medical, dental, and vision coverage
- Paid time off plan
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What This Job Offers
Job Type
Full-time
Career Level
Senior
