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Validation and Compliance Specialist
3 weeks ago
We are a dynamic team of professionals dedicated to delivering excellence in quality assurance and compliance. Our team members are passionate about their work and strive to create high-performing teams that exceed client expectations.
Job Summary
This role offers an exciting opportunity to join our science, engineering, and commercialization team, supporting the transition of a facility from construction and project phase to a fully operational facility delivering life-saving products to patients.
The ideal candidate will have demonstrated experience in at least two key areas, including vial and syringe sterile operations, cleaning validation, sterilization, single-use technologies, filter validation, and ancillary equipment for bio-processing. They will be responsible for managing workload, providing coaching for a team of validation engineers, and aligning new facility introduction with validation approach across site.
Main Responsibilities
- Commissioning and qualification of process equipment, ensuring right-first-time commissioning and qualification effort
- Technical review and approval of commissioning protocols, qualification protocols, and validation protocols executed by vendors, cross-functional groups, and/or validation counterparts
- Support regulatory submissions as required
Requirements
- Minimum 6 years directly related experience in academia, pharmaceutical, or biotechnology industry
- Working knowledge of current regulatory requirements and current good manufacturing practices
- Self-starter with results-focused mindset
- Strong contemporary knowledge and ability to work independently and on multidisciplinary teams
Preferred Experience and Skills
- Minimum 2 years process equipment C&Q/ QA/ validation experience on Greenfield/Brownfield, Large Scale Project, or new facility introduction
- Presenting of QA/QC/validation documents to regulatory agencies/inspectors and defending approach
- SME on equipment qualification on any cleaning & parts washers, vaporised hydrogen peroxide isolators, clean utilities & transfer panels, vial & syringe filling & inspection
