Sr. Manager, Sterility Assurance - Thermo Fisher Scientific : Job Details

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Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Work ScheduleStandard Office Hours (40/wk)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $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, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding 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 and Patheon. For more information, please visit www.thermofisher.com.Position SummaryAccountable for Sterility Assurance across site and will own/promote/define the systems listed as key responsibilities. Lead the Sterility Assurance department.Key Responsibilities:

• Contamination Control Strategy (define/own/maintain for the site)
• Environmental Monitoring program (define/oversee/improve)
• Media Fill Program (oversee)
• Aseptic Comportment/Training/Oversight (oversee and manage)
• Sterilization processes (oversee)
• Risk assessments and improvement programs (implement/manage - against current and future expectations)
• Lead major investigations into issue impacting Sterility Assurance (i.e. Adverse EM trends, media fill failures)
• Review & approve any Major/Critical deviation and any change proposals with Sterile Assurance impact (lead)
• Staying up to date with best practice and sharing that knowledge (10% of time should be devoted to this)
• Act as SME for the above with regulators / clients (i.e. key part of major audits)
• Act as SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
• Implementing standard processes (i.e. ensuring understanding / compliance with updated Annex 1 – owning the transition and any risk assessments we need)
• Represent site on the Sterile Working Group (potential future team leader) harmonizing practices across sites in the network
• Report status of and promote Sterility Assurance within the Senior Leadership Team (lead)
• Manage the Sterility Assurance department
• Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)

Education:

• Bachelor's degree minimally required, preferably Microbiology, Applied Biology, Life Sciences, or some comparable field.

Experience:

• At least 5 years of exprience in an applied microbiology, aseptic processing, or equivalent role
• At least 5 years of multifunctional experience working in a pharmaceutical quality function, preferably in sterile manufacturing (Auditing, Manufacturing QA, Quality Compliance, etc).
• At least 2 years of experience in some relevant management, supervisory, or leadership role
• Detailed knowledge of sterile processing at a supervisory/management level, ideally will have led one or more sterile production lines, or, led teams that directly support sterile production.
• Experience with validation of sterile processes would be important
• Involvement in capital projects (new build/refurbishment of sterile lines) would be useful.
• Intimate knowledge of Annex 1 and similar regulations
• Demonstrable audit/client facing experience.

Key Skills:

• Influencing
• Curiosity
• Networking
• Assertiveness
• Diplomacy

Benefits: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!

Seniority level

• Seniority levelNot Applicable

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance, Product Management, and Engineering
• IndustriesPharmaceutical Manufacturing and Biotechnology Research

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