Sr. Manager, Sterility Assurance
Sr. Manager, Sterility Assurance
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
Thermo 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 100000 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 .
Position Summary
Accountable 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:
Bachelors 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!
Required Experience:
Manager
Employment Type
Full-Time
