Sterility Assurance Manager

SHARP STERILE MANUFACTURING LLC•Lee, MA

About The Position

The Sterility Assurance Manager ensures sterility the leads contamination control program, aseptic processing simulation (media fill) program, manages audit interactions related to sterility assurance.

Requirements

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
Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar required
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)
Ability to sit for prolonged periods of time
Ability to stand for prolonged periods of time
Ability to lift up to 20lbs

Nice To Haves

Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial

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
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
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.