Sterility Assurance Manager
Thermo Fisher Scientific
Sterility Assurance Manager
Job Description
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence 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 shiftJob DescriptionGROUP/DIVISION SUMMARYThe 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 SUMMARYThe 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 programOversee the Media Fill ProgramLead the aseptic Comportment/Training/OversightOversee sterilization processesImplement and Lead risk assessments and improvement programs against current and future expectationsLead 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 needRepresent site on the Sterile Working Group, and facilitate harmonizing practices across sites in the networkAudit 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, AbilitiesInvolvement 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 skillsInfluencingcGMP ComplianceStrong sense of diplomacy and assertivenessQuality JudgementEffective 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 OfferWe 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!CompensationCompetitive PayAnnual performance-based bonusAnnual merit performance-based increaseExcellent BenefitsBenefits & Total Rewards | Thermo Fisher ScientificMedical, Dental, & Vision benefits-effective Day 1Paid Time Off & Designated Paid Holidays401KTuition ReimbursementEmployee Referral BonusCareer Advancement Opportunities
Locations
- USA, North Carolina, Greenville
Skills Required
- pharmaceutical quality functionintermediate
- active aseptic manufacturing operationintermediate
- aseptic processingintermediate
- aseptic process simulationsintermediate
- pharmaceutical industry technologyintermediate
Required Qualifications
- Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar required. (degree in of science degree in relevant area)
- 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). (experience, 7 years)
- 5 years of leadership experience required. (experience, 5 years)
- Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site. (experience)
- Detailed knowledge of aseptic processing, and ideally will have practical experience in an active aseptic manufacturing operation. (experience)
- Knowledge of aseptic process simulations (media fills). (experience)
- Experience with pharmaceutical industry technology, especially from a validation, technical or laboratory role would be useful. (experience)
- Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar required. (degree in of science degree in relevant area)
- 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). (experience, 7 years)
- Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site. (experience)
- Detailed knowledge of aseptic processing, and ideally will have practical experience in an active aseptic manufacturing operation. (experience)
- Knowledge of aseptic process simulations (media fills). (experience)
- Experience with pharmaceutical industry technology, especially from a validation, technical or laboratory role would be useful. (experience)
- 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. (experience)
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.
- 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.
Benefits
- general: 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!
- general: Competitive Pay
- general: Annual performance-based bonus
- general: Annual merit performance-based increase
- general: Annual performance-based bonus
- general: Annual merit performance-based increase
- general: Benefits & Total Rewards | Thermo Fisher Scientific
- general: Medical, Dental, & Vision benefits-effective Day 1
- general: Paid Time Off & Designated Paid Holidays
- general: 401K
- general: Tuition Reimbursement
- general: Employee Referral Bonus
- general: Career Advancement Opportunities
- general: Paid Time Off & Designated Paid Holidays
- general: Tuition Reimbursement
- general: Employee Referral Bonus
- general: Career Advancement Opportunities
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