Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Purpose of the position/responsibility:
Support the Process Engineering Team in ensuring the introduction of new process for production of sterile injectable medicines, managed through technical documents, in compliance with current regulations (GMP standards, FDA, Ema etc.)
Specific tasks/primary activities:
Technical documents: Issuing of Engineering and Technical documents relating to the manufacturing processes that must be validated, in order to acquire information necessary for the execution of the tech transfer activities and the drafting of the trial reports, in compliance with the company procedures.
Drafting technical documentation.
Participate in the project teams discussing technical aspects of the new product introduction strategy to be submitted to the regulatory authorities.
Support the execution of operational activities from a technical point of view.
Review the data generated by the shopfloor activities and their analysis, in compliance with the protocols and company procedures.
Requirements and qualifications:
• Degree in Pharmacy, Chemistry, Biotechnology, Biology, Engineering or similar scientific degrees or consolidated experience;
• Previous experience in pharmaceutical companies or tech transfer/validation is helpful;
• Proficient English (both written and spoken);
• IT knowledge: Company IT systems (PMX, LIMS, Trackwise, Minitab) and Microsoft Office tools;
• Personal skills: Excellent interpersonal skills, proactivity, ability to work in a team.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.