Process Engineer (pharmaceutical- bioprocess manufacturing science and technology)

Experteer Italy; Bologna; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a Process Engineer to manage technology transfer projects and ensure compliance with regulatory standards. The ideal candidate will have extensive experience in project management and knowledge of complex pharmaceutical manufacturing processes. This hybrid role requires travel throughout Italy and potentially some European travel.

Competenze

• At least 4/5 years of experience in a Technology Transfer team.
• Experience managing or involved in at least 5 TT projects.
• Knowledge of Pharma GMPs and complex pharmaceutical manufacturing processes.

Mansioni

• Lead and manage technology transfer projects in pharmaceutical manufacturing.
• Ensure compliance with regulatory requirements and GMP standards.
• Develop metrics and lead teams to achieve performance goals.

Conoscenze

Technology Transfer

Project Management

Change Control

CAPA process

Identifying Critical Attributes

Commissioning and Qualification

Developing User Requirements

Schedule Development

Leading Team to Achieve Goals

Descrizione del lavoro

Process Engineer (pharmaceutical- bioprocess manufacturing science and technology)

CAI

Specialista Senior / Project Manager

Europe Life Sciences – South Europe /

Full Time /

Hybrid

Regulatory Knowledge: Pharma GMPs main regulations knowledge (at least comprehension and/or ability to work on):

- Technology Transfer: at least 4/5 years of experience in a TT team as Process Technology SME (alias process Manufacturing Science and Technology/Process Engineer) or Process Validation SME

- Experience in project management in TT projects or similar context

- Management or involvement in an average number of TT projects (not less than 5)

- Experience in manufacturing of complex pharmaceutical forms such as: aseptic process of drug product, lyophilized products, biological products, biotechnology/ biosimilar products

Other Desired Experience:

• Change Control
• CAPA process
• Identifying Critical Attributes and Critical Process Parameters
• Commissioning and Qualification
• Developing User Requirements
• Schedule development and execution
• Establishing metrics and leading team to achieve performance goals

Suitable candidates must be available for travel throughout Italy and some European travel may be required.