Validator
1 day ago
Validation Specialist - Syringe Filling Line
About the Role:
This is an opportunity to work as a Validation Specialist on a Syringe Filling Line for a Sterile fill finish facility. The role involves ensuring that all validation activities are in compliance with Good Manufacturing Practices (GMP) and quality requirements.
The Validation Specialist will be responsible for generating, executing, reviewing and approving qualification documentation. This includes development of protocols, execution and review of test data, and final approval of completed qualifications.
Responsibilities:
- Generate and execute qualification protocols.
- Review and approve test data.
- Develop and maintain site validation master plans and standard operating procedures.
- Collate and report on relevant validation data.
- Assist in resolving deviations and conducting root cause analysis.
- Review and approve qualification summary reports.
- Generate validation summary reports.
Requirements:
- Minimum 6 years experience in engineering or validation.
- Degree in engineering or equivalent qualification.
- Extensive knowledge and demonstrated experience in validation activities for pharmaceutical/biotechnology projects.
- Experience working with sterile/biotech equipment preferred.
- Familiarity with GMP requirements and safety standards.
- Strong communication and interpersonal skills.
Benefits:
This contract role offers a minimum 12-month commitment with potential for extension. Hourly rate €60-€80 per hour.
Hybrid work arrangements available with requirement for full-time onsite presence during key deliverables.
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