Senior Validation Engineer
4 weeks ago
We are seeking a highly skilled CQV Engineer to join our team at EPM Scientific in Philadelphia. Our client, a leading pharmaceutical company, is looking for an expert to support their operations in the development and distribution of innovative medications.
Key Responsibilities:
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure systems and equipment meet design and operational requirements.
- Develop and execute protocols for Design Qualification, Factory Acceptance Tests (FATs), Site Acceptance Tests (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
- King of Prussia, PA
- W2 only
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