
Senior Validation Expert
4 days ago
Job Role: Senior Validation Expert
We are seeking a highly experienced professional to lead our commissioning and qualification efforts. As a CQV specialist, you will plan, coordinate, and execute the validation of computer systems, equipment, and analytical instruments.
Key Responsibilities:
- Commissioning and Qualification: Develop and execute comprehensive commissioning and qualification plans for manufacturing process equipment, package units, analytical instruments, freezers, and other related systems.
- Validation Execution: Conduct FAT, SAT, IQ, OQ, PQ of equipment and analytical instruments according to internal procedures and industry standards.
- Lifecycle Management: Create, review, and approve equipment qualification and analytical instruments lifecycle documentations, including protocols and reports, risk assessments, and technical specifications.
- Investigations: Lead investigations into discrepancies identified during qualification activities.
Essential Skills and Qualifications:
- Experience: Relevant experience in validation activities, including creation, execution, and review of validation lifecycle documents.
- Leadership Skills: Strong leadership skills in daily validation meetings with cross-functional teams to resolve validation issues.
- Equipment Qualification: Proven experience in equipment qualification, including analytical instrumentation and manufacturing equipment.
- Industry Knowledge: Work experience in Pharmaceutical or BioPharma industries.
- Validation Execution: Hands-on validation execution experience.
- Cleanroom Environment: Ability to work in a cGMP environment, including cleanrooms or technical areas.
Why Apply:
- Opportunity to utilize your expertise in validation activities, leadership skills, and equipment qualification.
- Chance to work in a dynamic environment with a strong focus on quality and compliance.
- Collaborative team culture with opportunities for growth and development.
If you have a strong background in the Life Sciences industry and are looking for a challenging role that utilizes your skills and experience, please submit your application.
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