Jobid=fabe7f01b3f0 (0.0252)
Sterility Assurance Specialist – Pharmaceutical Manufacturing
A leading pharmaceutical development and manufacturing company is seeking a Sterility Assurance Specialist to drive contamination control and aseptic excellence across sterile production operations.
Key Responsibilities:
- Champion a sterility-focused culture and ensure compliance with GMP and regulatory standards.
- Advise on facility and cleanroom design, equipment selection, and process flows to mitigate contamination risks.
- Oversee aseptic manufacturing of sterile drug products (lyophilized, solution, suspension).
- Lead validation and qualification of equipment, utilities, sterilization, and cleaning processes.
- Develop and implement contamination control strategies aligned with Annex 1 (2022) and industry best practices.
- Manage cleanroom classifications, gowning protocols, and environmental monitoring programs.
- Optimize aseptic operations using barrier technologies (RABS, isolators) and unidirectional flow principles.
- Supervise sterilization systems (autoclaves, SIP, CIP) and media fill simulations.
- Support container closure integrity testing and aseptic process qualifications.
- Deliver training on aseptic techniques, cleanroom behavior, and incident response.
- Maintain sterility assurance documentation and lead investigations, audits, and inspections.
Candidate Profile:
- BSc/MSc in Microbiology, Pharmacy, or related field.
- Extensive experience in sterility assurance within pharmaceutical manufacturing.
- Deep knowledge of GMP, aseptic processing, contamination control, and validation.
- Strong technical expertise in cleanroom operations, sterilization technologies, and environmental monitoring.
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
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