Process Engineer

ThermoFisher Scientific; Monza; On-site; EUR 45,000 - 65,000; Full time

Job summary

Thermo Fisher Scientific in Italy is seeking a Process Engineer to support the introduction of new manufacturing processes for sterile injectable medicines. You will manage technical documents and ensure GMP compliance while assisting tech transfer activities.

Responsibilities include drafting documentation, participating in project teams, reviewing shopfloor data, and supporting technical operations. English proficiency and IT tool knowledge are essential; teamwork and a proactive attitude are

Qualifications

• Degree in Pharmacy, Chemistry, Biotechnology, Biology, Engineering or similar degree.
• Experience in pharma or tech transfer/validation is helpful.
• Proficient English (written and spoken).
• IT knowledge: PMX, LIMS, Trackwise, Minitab and Microsoft Office tools.

Responsibilities

• Issuing of Engineering and Technical documents relating to manufacturing processes to enable tech transfer.
• Drafting technical documentation.
• Participate in project teams to discuss technical aspects of new product introduction for regulatory submission.
• Review shopfloor data and analyses in accordance with protocols and procedures.

Skills

Teamwork

English

IT skills

Interpersonal skills

Proactive

Education

Degree in Pharmacy/ Chemistry/ Biotechnology/ Biology/ Engineering

Tools

PMX

LIMS

Trackwise

Minitab

Job description

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.

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.