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Thermo Fisher Scientific · 1 day ago

Sterility Assurance Manager

Greenville, NC

Full-time

Onsite

Senior Level

7+ years exp

Thermo Fisher Scientific is a leading organization in the Pharma Services Group, specializing in sterile injectable and oral solid dose drug products. The Sterility Assurance Manager is responsible for overseeing sterility assurance across the site, leading contamination control strategies, and ensuring compliance with industry standards.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Contamination control strategy (define/own/maintain for the assigned areas)

Define, oversee, and improve the EM program

Oversee the Media Fill Program

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

Staying up to date with the best approach and sharing that knowledge (10% of time should be dedicated to this)

Act as Subject Matter Authority (SME) with regulators / clients (i.e. key part of audits)

Act as SME for new product introduction and for applicable capital projects (i.e. new lines/processes)

Implementing standard methodology (i.e. ensuring understanding / compliance with updated Annex 1 – leading the transition and any risk assessments we need

Represent site on the Sterile Working Group, and facilitate harmonizing practices across sites in the network

Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)

Follows all job-related safety and other training requirements

Qualification

MicrobiologyAseptic processingEnvironmental MonitoringPharmaceutical qualityCGMP ComplianceRoot Cause AnalysisLeadership experienceTechnical writingAttention to detailInterpersonal skills

Required

Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar required

7 years of experience Microbiology experience is crucially required for this role. (Preferably, Micro Laboratory or Environmental Monitoring experience, and ideally within a sterile pharmaceutical manufacturing facility)

5 years of leadership experience required

Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site

Detailed knowledge of aseptic processing, and ideally will have practical experience in an active aseptic manufacturing operation

Knowledge of aseptic process simulations (media fills)

Experience with pharmaceutical industry technology, especially from a validation, technical or laboratory role would be useful

Preferred

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

Leadership experience, and supervisory experience is helpful

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 and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality

Requires discretion and independent judgment