As an Equipment & Systems Specialist, you will contribute to the heart of our operations, ensuring the seamless functionality of our essential instruments. You'll tackle the dynamic challenges of deploying, qualifying, and maintaining complex equipment within a cGMP environment, requiring a blend of technical prowess and meticulous attention to detail. Your expertise in life sciences, biotechnology, or engineering, coupled with your experience in a regulated setting, will be pivotal in upholding our commitment to innovation and quality.
Responsibilities:
- Deployment: oversee the introduction and setup of new instruments, ensuring operational readiness and compliance.
- Coordination: manage the qualification and routine maintenance of instruments, contributing to their uninterrupted performance.
- Documentation: review, assess, and author technical and lifecycle documents, including URS, IQs, OQs, and PQs, maintaining rigorous standards.
- Integrity: ensure data accuracy and proper user management of equipment, safeguarding the integrity of our research outputs.
- Collaboration: work closely with vendors during qualification and maintenance activities, and support change controls and deviation investigations.