Sterility Assurance Manager
Sterility Assurance Manager
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1 Vacancy
Job Description
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob 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.
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.
- 5 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 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
- Paid Time Off & Designated Paid Holidays
- 401K
- Tuition Reimbursement
- Employee Referral Bonus
- Career Advancement Opportunities
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other non-disability related technical issues will not receive a response.
Required Experience:
Manager
Employment Type
Full-Time
