APS & Sterility Specialist

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

What Makes This Opportunity Unique

At Thermo Fisher Scientific Inc., we provide a highly collaborative and multifaceted environment where you can excel and make a meaningful difference in the world.

Join our APS & Sterility team and work alongside top-tier experts committed to achieving our mission flawlessly!

In this role, you have the chance to define and implement standard methodologies, playing a vital role in establishing our position as a pharmaceutical industry leader.

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• Develop and issue APS protocols and reports for manufacturing sterile lyophilized and liquid drug products. Adhere to GMP and corporate standards, including modern pharmaceutical technologies like fill-finish processes under isolators.
• Issue manufacturing instructions for APS runs to ensure execution of production processes.
• Issue technical reports and risk assessments pertaining to operator qualification, qualified holding times, and aseptic interventions.
• Ensure appropriate management and archiving of documentation in line with GMP and internal procedures.
• Coordinate manufacturing activities to ensure strict compliance with established protocols.
• Support in the preparation and update of APS department Standard Operating Procedures (SOPs).
• Ensure all relevant activities are assessed and led through change control management.
• Participate in clients' and regulatory audits concerning APS activities.
• Support our client service delivery performance at the highest level by feeding positive relationships with clients and ensuring timely coordination and communication.
• Provide adequate reporting to Area Management about potential issues to maintain seamless operations.

• Educational Background: Degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology.
• Industry Experience: At least 2-3 years of experience in the pharmaceutical or chemistry industry.

• Language Proficiency: Proficient in English and Italian.
• Sterility Assurance: Proven knowledge of sterility assurance concepts.
• Pharmaceutical Legislation: Familiarity with pharmaceutical legislation and national/international laws.
• Social Skills: Excellent interpersonal skills and a demonstrated ability to work effectively in a team.
• Technical Documentation: Strong propension towards the preparation of technical documentation.
• Attention to Detail: Remarkable attention to detail and precision.
• Organizational Skills: Outstanding ability to efficiently manage and complete multiple tasks.