Sterility Assurance Lead Biotech Scale-Up
Join a leading biotech company in an exciting growth phase, working on the forefront of microbiology and cleanroom management. We are currently seeking a Sterility Assurance Lead to lead key projects.
Key Responsibilities:
* Lead and manage cleanroom upgrades from Grade D to Grade A.
* Develop and implement action plans, including timelines and risk management.
* Ensure compliance with GMP, regulatory bodies, and industry standards.
* Oversee environmental monitoring programs and analyze data for trend identification.
* Manage aseptic process simulations and validation activities for cleanrooms.
* Collaborate with cross-functional teams (Quality, Operations, Engineering) to maintain microbiological quality.
* Train staff on SOPs, aseptic processes, and contamination control.
* Investigate and resolve microbiological deviations.
* Conduct risk assessments and implement contamination control strategies.
Qualifications:
* Strong background in microbiology, GMP compliance, and cleanroom environments.
* Minimum of 5 years' experience in a similar role
* Bachelor's degree in microbiology, Biotechnology or equivalent
* Experience with validation of manufacturing equipment and HVAC systems.
* Skilled in environmental monitoring and bioburden control.
Why this Role?
* Be part of a team dedicated to innovation and quality in biopharmaceutical manufacturing.
* Work on a variety of impactful projects
* Collaborate with industry experts in a supportive, growth-oriented environment.
* Support with further education /training
* Hybrid work option after completion of probationary period
The estimated salary range for this position is $80,000 - $120,000 per year, depending on experience and qualifications.