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Validation and Commissioning Engineer
2 months ago
We are seeking an experienced Commissioning, Qualification, and Validation (CQV) professional to join our team at PSC Biotech. As a CQV Specialist, you will play a critical role in ensuring the commissioning, qualification, and validation of equipment and systems within the pharmaceutical and medical device industries.
Key Responsibilities- Develop and execute commissioning, qualification, and validation protocols for a range of equipment and systems.
- Draft, review, and deploy all required validation documentation, including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, and reports.
- Provide technical expertise throughout the validation lifecycle, including risk assessment, deviation investigation, and change control activities.
- Support environmental monitoring tasks as required.
- 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 project timelines and deliverables and drive successful validation of critical systems and equipment.
- Contribute to the continuous improvement of validation processes and procedures.
- Ensure compliance with industry regulations and requirements at all times.
- Bachelor's degree in a related engineering discipline.
- 5 years or more of experience executing commissioning, qualification, and validation for a range of equipment within the pharmaceutical and/or medical device industries.
- Knowledge of regulatory requirements, including cGMP and FDA.
- 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 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 allows our employees to grow and thrive.
About PSC BiotechPSC 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 passionate about bringing together the best and brightest professionals to form a truly special team.
