Job Description
Job Description
Position Summary
The Sterility Assurance Manager ensures sterility the leads contamination control program, aseptic processing simulation (media fill) program, manages audit interactions related to sterility assurance.
Duties and Responsibilities
- Oversee the Media Fill Program
- Plan and design aseptic process simulations aligning with regulatory expectations, including frequency, number of runs, and risk‑based requirements.
- Ensure APS simulates full aseptic processing from sterilization steps through container sealing, including all product-contact and environmental interfaces.
- Conduct contamination risk assessments and ensure worst‑case scenarios are adequately represented in APS design.
- Define, own and maintain contamination control strategy for all areas
- Lead the aseptic Comportment/Training/Oversight
- Oversee sterilization processes
- Implement and lead risk assessments and improvement programs against current and future expectations
- Lead sophisticated investigations into issues impacting Sterility Assurance (i.e. Adverse EM trends, media fill failures)
- Review & approve any major/critical deviations and change proposals with Sterility Assurance impact for the assigned areas
- Remain up-to-date with the best approach to sterility assurance
- Act as Subject Matter Authority (SME) with regulators and customer audits and other interactions.
- Act as SME to support new product introduction and for applicable capital projects (i.e. new lines/processes)
- Implement standard methodology
- Facilitate harmonizing practices across the site
- Follow all job-related safety and other training requirements
- Other duties as assigned
Regulatory Responsibilities
- Maintain working knowledge of 21 CFR 210/211, 21 CFR 820, EU Annex 1, and related regulations
- Ensure all work is performed in accordance with current regulatory requirements and internal SOPs
- Support data integrity initiatives and provide input to compliance metrics
Supervisory Responsibilities
- Supervise and develop a team of Specialists providing on-the-floor and documentation support.
- Provide regular feedback, performance evaluations, and coaching to team members.
- Coordinate staffing to support manufacturing schedules and priority projects.
Experience
- Five plus (5+) years of Microbiology or Sterile Manufacturing experience, ideally within a sterile pharmaceutical manufacturing facility
- Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site.
- Experience with pharmaceutical industry technology, especially from a validation, technical or laboratory role would be preferred
Education
- Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar required
Knowledge, Skills & Abilities
- Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial
- Familiarity with U.S. FDA, EU Annex-1 and other regulations and guidance
- Strong investigative skills, preferably familiar with Root Cause Analysis methods
- Shown expertise with audits and client-facing roles
- Outstanding technical writing skills
- Influencing
- cGMP Compliance
- Strong sense of diplomacy and assertiveness
- Quality Judgement
- Effective time management and prioritization skills
- Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters
- Outstanding attention to detail and organizational skills
- Self-starter, mature, independent and conscientious
- Ability to work in a fast-paced environment under pressure
- Able to multi-task
- Results-oriented
- Ability to maintain a high degree of confidentiality
- Requires discretion and independent judgment
- Detailed knowledge of aseptic processing and practical experience in an active aseptic manufacturing operation
- Knowledge of aseptic process simulations (media fills)
Physical Requirements
- Ability to sit for prolonged periods of time
- Ability to stand for prolonged periods of time
- Ability to lift up to 20lbs