CQV Engineer
2 weeks ago
We are working with a leading pharmaceutical company that are looking for someone to join their team as a CQV Engineer in Philadelphia. The company has grown to become a key player in the development and distribution of innovative medications with a strong focus on treatments for chronic diseases such as diabetes, cardiovascular conditions, and neurological disorders.
Key Responsibilities:
- Perform IQ, OQ and PQ to ensure systems and equipment meet design and operational requirements.
- Prepare and execute protocols for Design Qualification, FATs, SATs and other validation activities.
- Document and prove that systems impacting product quality and patient safety are correctly installed and function as expected.
- Develop and execute validation protocols to ensure consistent and reproducible results.
- Conduct systematic start-up of manufacturing systems.
- Verify that equipment is installed as specified and functions properly.
- Ensure systems are ready for operational use.
- Create and maintain detailed records of validation activities.
- Ensure compliance with industry guidelines and regulatory standards
- Generate, review, and edit Standard Operating Procedures (SOPs).
- Document impact and risk assessments.
Requirements:
- 2-5 years of experience in Commissioning, Qualification, and Validation (CQV) within pharmaceutical, biotech, or GMP manufacturing environments.
- Practical experience in a GMP facility in roles such as Process Engineering, Facilities, or Operations is advantageous.
Contractual Details
- 40 Hours per week
- 12 month contract with potential for extension
- Start date: ASAP
- King of Prussia, PA
- W2 only
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