Commissioning, Qualification, Validation Specialist
3 days ago
We are seeking an experienced CQV Engineer to support the commissioning, qualification, and validation of facility equipment and systems within the pharmaceutical and/or biotechnology industry.
Key Responsibilities- Lead the development and execution of commissioning, qualification, and validation protocols for plant equipment.
- Draft, review, author, and deploy all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and more.
- Provide technical expertise throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities.
- Effectively identify potential risks and areas of improvement and proactively implement risk mitigation.
- Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
- Collaborate with cross-functional teams to support all project timelines and deliverables and drive successful validation of critical systems and equipment.
- Contribute to the continuous improvement of validation processes, procedures, and projects.
- Manage projects from initiation to completion, ensuring compliance with regulatory requirements and company standards.
- Ensure compliance with industry regulations and requirements at all times.
- Bachelor's degree in a related engineering discipline.
- 3 years or more of experience executing commissioning, qualification, and validation for a range of facilities equipment and systems within the pharmaceutical and/or biotechnology industries.
- Knowledge of regulatory requirements (cGMP, FDA, etc.).
- Experience working with HVAC and water systems preferred.
- Project Management experience or certification preferred.
- Excellent problem-solving, analytical, and technical skills.
- Strong time management and organizational abilities.
- Effective communication and interpersonal skills.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- Ability to work independently and as part of a team.
PSC Biotech is committed to providing a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance.
We also offer a competitive salary range of $100,000 - $120,000 annually, based on qualifications and experience.
PSC Biotech is an equal opportunity employer and welcomes applications from diverse candidates.
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Los Angeles, California, United States PSC Biotech Full timePSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products. We are seeking an experienced CQV Engineer to support the commissioning, qualification, and validation of facility equipment and systems within the...
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