Sterility Assurance Coordinator
Biotech Scale-Up
Join a leading biotech company in an exciting growth phase, working on the forefront of microbiology and cleanroom management currently seeking a Sterility Assurance Coordinator to lead key projects.
Key Responsibilities:
1. Lead and manage cleanroom upgrades from Grade D to Grade A.
2. Develop and implement action plans, including timelines and risk management.
3. Ensure compliance with GMP, regulatory bodies, and industry standards.
4. Oversee environmental monitoring programs and analyze data for trend identification.
5. Manage aseptic process simulations and validation activities for cleanrooms.
6. Collaborate with cross-functional teams (Quality, Operations, Engineering) to maintain microbiological quality.
7. Train staff on SOPs, aseptic processes, and contamination control.
8. Investigate and resolve microbiological deviations.
9. Conduct risk assessments and implement contamination control strategies.
Qualifications:
1. Strong background in microbiology, GMP compliance, and cleanroom environments.
2. Minimum of 5 years' experience in a similar role.
3. Bachelor's degree in microbiology, Biotechnology or equivalent.
4. Experience with validation of manufacturing equipment and HVAC systems.
5. Skilled in environmental monitoring and bioburden control.
If you're a Sterility Assurance Coordinator/Microbiologist with a passion for driving quality and innovation in biotech, I want to hear from you!
Why this Sterility Assurance Coordinator Job?
1. Be part of a team dedicated to innovation and quality in biopharmaceutical manufacturing.
2. Work on a variety of impactful projects.
3. Collaborate with industry experts in a supportive, growth-oriented environment.
4. Support with further education /training.
5. Hybrid work option after completion of probationary period.
Ready to take the next step in your career? Apply now!
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