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Location / Division Specific Information
The pharmaceutical manufacturing plant in Ferentino (80km from Rome), with more than 850 employees, is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyophilized formulations, with an increasing focus on biologics.
How will you make an impact?
The Sterility Assurance Lead, reporting directly to the Site Quality Head and collaborating with the global Quality structure, will be accountable for sterility assurance across site and will own / promote / define the systems listed as key responsibilities in order to guarantee the highest quality standard and sterility excellence of the Ferentino’s manufacturing site.
What will you do?
Contamination control strategy
EM & APS program
Aseptic Comportment / Training / Oversight
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
Staying up to date with best practice and sharing that knowledge (10% of time should be devoted to this)
Act as SA SME for the above with regulators / clients (i.e. key part of major audits)
Act as SA SME for new product introduction and for applicable capital projects (i.e. new lines / processes)
Implementing best practice (e.g. ensuring understanding / compliance with SA related regulations & guidance owning the transition and any risk assessments we need)
Represent site on the Sterile Working Group (potential future team leader) actively harmonizing practices across sites in the network
Report status of and promote Sterility Assurance within the Senior Leadership Team (lead)
Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)
How will you get here?
Relevant science based degree; e.g. Microbiology, Applied Biology.
Management qualifications (or equivalent experience).
Typically from a microbiology QC background, ideally within a sterile manufacturing site.
Substantial experience working in a pharmaceutical quality function, preferably within a sterile manufacturing site.
Has intimate knowledge of sterile processing at a supervisory / management level, ideally will have managed one or more sterile production lines.
Experience with validation of sterile processes would be advantageous
Involvement in capital projects (new build / refurbishment of sterile lines) would be advantageous
Intimate knowledge of Annex 1 and similar guidance
Demonstrable audit / client facing experience.
Knowledge, Skills, Abilities
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