Aps & Sterility Specialist

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $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, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an unrivaled 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, Patheon and PPD.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

• Location / Division Specific Information
• How will you make an impact?

The resource will become part of a lively and dynamic team which is responsible for the aseptic validation process of products’ manufacturing in Monza site, by managing Aseptic Process Simulation (APS) documentation and supervising on the floor operations, in close contact with Client’s technical and quality teams, and in accordance with Regulatory guidance.

APS & Sterility specialist is a key element for the Company core business. This person collaborates with Project Managers, Process Engineers and Client technical teams, within Monza site Quality Unit.

• What will you do?
• Analysis of technical documentation related to new protocols;
• Issuing APS protocols and reports for, in accordance with GMP and corporate standards; Collect necessary information by involving relevant functions. Processes object of APS are : manufacturing of sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes), as well as modern pharmaceutical technologies (i.e. fill finish processes under isolators);
• Issue of manufacturing instructions (MBR) for APS batches;
• Issue of technical reports and risk assessments related to operator qualification, qualified holding times, aseptic interventions
• Ensure correct management and archiving of documentation in line with GMP and internal procedures;
• On-the-floor overlooking of manufacturing activities related to APS batches;
• Support in preparation and update of APS department SOPs.
• Ensure that all relevant activities are adequately evaluated and managed through change control management
• Support in preparation and participation to Clients’ and Regulatory audits with regards to APS activities.
• Ensure that our client service delivery performance is maintained at the highest level, by building strong relationships with our clients and coordinating activities to ensure the clients are kept informed in a timely manner.
• Ensure an adequate reporting to the Area Management about potential issues
• How will you get here?
• Degree in Pharmacy / CTF / Biological Sciences / Chemistry / Industrial chemistry / Chemical engineering / Biotechnology
• At least 1-2 years of experience in pharma / chemistry industry
• Knowledge, Skills, Abilities
• English and Italian fluent
• Knowledge of sterility assurance concepts
• Knowledge of pharmaceutical legislation and national / international laws
• Good social skills, team working
• Propension to preparation of technical documentation
• Organizational skills

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.