Sterility Assurance Manager

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/ Division Specific Information 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.
What will you do? Accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of operation.
Contamination control strategy (define/own/maintain for the assigned areas) EM program (define/oversee/improve) Media Fill Program (oversee) Aseptic Comportment/Training/Oversight (Manage) Sterilization processes (oversee) Risk assessments and improvement programs (implement/manage - 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 best practice (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, and facilitate harmonizing practices across sites in the network Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required) How will you get here? Education: Minimum required education: Bachelor of Science Degree in relevant area; e.
g.
Microbiology, Applied Biology, or similar.
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 and 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 Our Mission is to enable our customers to make the world healthier, cleaner and safer.
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