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Skills: Contamination Control Strategy, Environmental Monitoring, Aseptic Processing, Media Fill Program, Sterilization Processes
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Senior$29B raised
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Charlotte, North Carolina, United States · On-site
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Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Paid Time Off, Designated Paid Holidays, 401k
Posted 30d ago
~40 hrs/week
Responsibilities
The Sterility Assurance Manager is responsible for defining and maintaining the contamination control strategy and overseeing the environmental monitoring and media fill programs. They act as the subject matter expert for regulators and clients while leading investigations into sterility assurance issues.
Requirements
Requires a Bachelor of Science in Microbiology or a related field with at least 7 years of microbiology experience and 5 years of leadership experience. Candidates must have detailed knowledge of aseptic processing and familiarity with U.S. FDA and EU Annex-1 regulations.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift
Job Description
GROUP/DIVISION SUMMARY
The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
Relocation assistance is NOT provided.
Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screening.
POSITION SUMMARY
The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of operation.
Key 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.
Qualifications:
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.
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.
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.
PHYSICAL REQUIREMENTS:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
What We Offer
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Compensation
Competitive Pay
Annual performance-based bonus
Annual merit performance-based increase
Excellent Benefits
Benefits & Total Rewards | Thermo Fisher Scientific
Medical, Dental, & Vision benefits-effective Day 1
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
How much do Manufacturing jobs in North Carolina pay?
Based on 1494 listings with disclosed salaries, most manufacturing jobs in North Carolina pay between $69k–$165k per year. Individual offers vary with seniority, company size, and specialization.
How many Manufacturing jobs are open in North Carolina right now?
There are currently 8,702 open manufacturing positions in North Carolina listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in North Carolina?
Companies currently hiring include Corning Incorporated, Eaton, ABB, Butterball, RTX, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in North Carolina?
Yes — 733 of the 8702 open manufacturing positions offer remote or hybrid work (188 remote, 545 hybrid).
How do I apply for Manufacturing jobs in North Carolina?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.