Biotechnology Validation and Commissioning Expert
6 days ago
We are seeking a seasoned Biotechnology Validation and Commissioning Expert to join our team at Team Horizon's Dublin manufacturing facility and lead the implementation of a new syringe filling line project.
About the Role:
- Lead the development and execution of comprehensive qualification plans for the syringe filling line, incorporating FAT, IV's, FT's, SAT, and PQ's.
- Mentor junior engineers in the validation process, ensuring seamless knowledge transfer.
- Drive cross-functional collaboration to align with site Validation Master Plans and SOPs.
- Facilitate exception and deviation resolution, and conduct thorough root cause analysis.
- Oversee the creation and dissemination of quality-focused reports, highlighting key findings and recommendations.
- Contribute to the development of User Requirement Specifications (URS) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).
Qualifications and Requirements:
- At least 8 years of experience in validation and commissioning within the pharmaceutical industry.
- Advanced knowledge of GMP regulations and guidelines.
- Excellent leadership and communication skills.
- Aptitude for mentoring junior engineers.
- Strong analytical and problem-solving skills.
- Familiarity with paperless qualification systems is an asset.
- Comprehensive understanding of risk-based approaches to validation and commissioning.
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