Role: Commissioning, Qualification, and Validation (CQV) Engineer
Location: Cary, NC/ Boston, MA/ Albany, NY - Hiring for 3 sites
Duration: Long Term
**No C2C**
Job Description:
The Pharma CQV Engineer will be responsible for overseeing the commissioning, qualification, and validation (CQV) activities of pharmaceutical manufacturing equipment and systems to ensure compliance with regulatory standards (cGMP, FDA, etc.). This includes the preparation, review, and execution of validation protocols (IQ, OQ, PQ), risk assessments, and final reports.
Key Responsibilities:
- Lead the planning and execution of CQV protocols for pharmaceutical equipment, utilities, and facilities.
- Conduct commissioning activities such as equipment testing, calibration, and documentation to verify system performance.
- Develop and review validation documents including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) protocols.
- Ensure all validation activities are conducted in compliance with relevant regulatory and company standards.
- Perform risk assessments and gap analysis for equipment and systems.
- Coordinate with cross-functional teams, including engineering, quality assurance, and operations, to ensure successful project execution.
- Identify and troubleshoot issues during CQV execution, ensuring timely resolution and project completion.
- Maintain detailed documentation of all CQV activities, ensuring accuracy and traceability for audits and regulatory inspections.
- Stay up to date with industry trends, regulatory updates, and best practices in validation and quality.
Qualifications:
- Bachelor’s degree in Engineering, Biotechnology, or a related field.
- 3+ years of experience in CQV within the pharmaceutical or biotechnology industries.
- Strong knowledge of cGMP, FDA, and other regulatory requirements.
- Hands-on experience with validation of pharmaceutical manufacturing equipment and clean utilities (e.g., HVAC, WFI, compressed air).
- Experience with automated systems and process controls is a plus.
- Excellent problem-solving, communication, and project management skills.
- Ability to work independently and collaboratively in a fast-paced environment.
If you are looking for any other roles in the Life Sciences Industry, feel free to share your resume to sai@premierlifesciences.com along with the role of your interest - we are happy to provide H1B sponsorship & H1T if required.
**No C2C enquiries please**