Validation Specialist
4 weeks ago
PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the pharmaceutical and biotechnology industries.
Our team of experts is passionate about delivering exceptional results and driving client success. We are committed to fostering a culture of innovation, collaboration, and excellence.
Job SummaryWe are seeking a highly motivated and experienced Validation Engineer to join our team. The successful candidate will be responsible for developing and executing validation protocols, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements.
Key Responsibilities- Develop and execute validation protocols (IQ, OQ, PQ) for equipment and systems in pharmaceutical manufacturing and biotechnology environments.
- Write, review, and author validation documentation, including protocols, reports, and procedures.
- Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory requirements.
- Conduct risk assessments and validation impact assessments, and investigate and resolve validation-related issues and deviations.
- Analyze test results and data to ensure accuracy.
- Bachelor's degree in a related engineering discipline.
- 15 years of experience in commissioning, qualification, and validation for equipment and systems in pharmaceutical and biotechnology industries.
- Strong understanding of regulatory requirements and industry standards (cGMP, FDA, etc.).
- Proactive and motivated with excellent problem-solving, analytical, and technical skills.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a team.
PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance.
We are committed to providing a supportive and inclusive work environment that fosters growth and development.
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