Pharmaceutical Validation Expert
1 week ago
PSC Biotech is looking for an experienced Quality Assurance Engineer to lead the commissioning, qualification, and validation program for a new pharmaceutical facility. As a senior-level professional, you will be responsible for ensuring the quality and reliability of our facilities, utilities, and process equipment through testing, validation, and quality assurance processes.
Your key responsibilities will include:
- Leading quality reviews for CQV documentation for new pharmaceutical facilities
- Supporting the CQV program and operational readiness on new utilities and process equipment
- Providing 'on the floor' quality engineering during validation executions
- Conducting risk assessments and managing quality risks using tools like FMEA to ensure safety, reliability, and compliance with relevant industry standards and regulations
- Performing thorough analysis and interpretation of test results, identifying deviations, anomalies, and areas for improvement, and providing recommendations for corrective actions
- Defining validation requirements, including test objectives, scope, methodologies, and acceptance criteria, based on project specifications and customer requirements
We require:
- A Bachelor's Degree in engineering or life sciences from a four-year university
- 5-10 years of experience in quality engineering, preferably working at sites manufacturing sterile injectable pharmaceuticals
- Experience with facility startups and supporting CQV of utilities and equipment
- Advanced knowledge of GMP environments
- Excellent interpersonal and communication skills, verbal and written
We offer a competitive salary range of $120,000 - $160,000 per year, depending on experience, as well as a comprehensive benefits package that includes medical, dental, and vision insurance, 401(k) matching, PTO, and paid holidays. Our company is committed to equal employment opportunity and welcomes applications from diverse candidates.
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