Piper Companies is seeking a CSV/Validation Consultant in Summit, NJ to work for an innovative and growing pharmaceutical manufacturer.
This opportunity will initially be a 6 month contract with possibility for extensions.
Responsibilities for the CSV/Validation Consultant include:
- Maintain all qualified and validated equipment/systems in compliance with policies, guidelines and procedures
- Support lab and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
- Support the calibration, equipment qualification and validation activities
- ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
- Regularly review, prioritize and promptly respond to customer equipment qualification and support requests.
- Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls
- Develop the protocols, and associated reports while adhering to a change management process
Qualifications for the CSV/Validation Consultant include:
- 5+ years of experience within the pharmaceutical manufacturing industry or related regulated environment
- Blend of equipment validation and CSV
- Experience with FDA/GMP regulations
- B.S. in Engineering or related field required
Compensation for the Validation Consultant include:
- $45-$50/per hour; commensurate to experience
- Comprehensive benefits package
Please send all qualified resumes to Karen Pallone at firstname.lastname@example.org