What are the responsibilities and job description for the Process Validation Engineer position at Emerge?
Process Validation Engineer – Senior Level
Location : Near Rochester, NY
Type : Direct Hire
Salary : $85,000 to $108,000 per year, based on experience
Benefits : No-cost health insurance, 10% annual bonus
About the Role Emerge is seeking a Senior Process Validation Engineer for a growing medical device manufacturer near Rochester, NY. This role involves developing and executing validations to ensure compliance with internal and external regulatory standards. The engineer will also support writing validation protocols and reports, as well as data analysis. Our client is seeking candidate with highly regulated industry experience and 6 or more years of process validation experience. Experience in GMP environment or FDA compliance such as pharma, medical device, optical, food, etc. is preferred.
Key Responsibilities for the Process Validation ENgineer job near Rochester, NY include :
- Develop and maintain Master Validation Plans (MVP).
- Create and execute validation protocols for Facility, Utility, Cleanroom Qualification, Equipment Qualification, Process Validation, Cleaning Validation, and Test Validation.
- Collaborate with cross-functional teams to ensure equipment and process performance.
- Conduct qualification testing according to internal procedures or external standards.
- Analyze validation data and address any issues with root cause investigation.
- Produce detailed validation reports, including statistical analysis and conclusions.
- Supervise technicians in validation activities.
- Ensure compliance with current Good Manufacturing Practices (cGMP).
- Support internal and external Quality System Audits.
- Implement process improvements and corrective / preventive actions (CAPA).
- Address non-conformance reports (NCRs) with a focus on root cause and prevention.
- Mentor and train less experienced team members in validation methodologies.
Qualifications
If you are qualified for this position, please click “apply now”. Thank you in advance for applying; however, only qualified candidates will be contacted. #INDDHMFG
Who is Emerge? We are a global talent solutions company working with clients all over the world. We deliver managed sales, marketing, and business operations solutions to our clients. These solutions are an extension of your existing operations. We are committed to your success, working quickly and efficiently to provide tangible, measurable results.
Salary : $85,000 - $108,000
