GMP-Driven Pharma Project Engineer

ThermoFisher Scientific; Monza; On-site; EUR 60,000 - 80,000; Full time

Job summary

Thermo Fisher Scientific in Lombardy (Monza area) is seeking a Process Engineer to lead pharmaceutical process development projects. You will collaborate with clients, define design specs, and ensure GMP compliance throughout the project lifecycle.

The role requires a Master’s in mechanical or chemical engineering, 3+ years in GMP/GEP environments, and strong leadership and communication skills. English fluency is required; the position is on-site in Italy.

Qualifications

• Master's degree in mechanical or chemical engineering.
• 3+ years of experience in process engineering.
• Experience with GMP/GEP and pharmaceutical environments.
• Experience with API/chemical manufacturing projects.
• Strong leadership and communication skills.
• Fluent English.

Responsibilities

• Join call/meeting with clients to provide technical information and collect all process requirements (URs)
• Provide technical input in the project team for own discipline, having technical and operational knowledge and expertise. Know how process development and know the internal requirements (operational/technical/compliance).
• Define and documents the technical specs (Design specifications, P&ID’s, layouts, functional specifications, ecc.) and review with the relevant SME.
• Follow the Good Engineering Practice (GEP)
• Follow up the construction and implementation activities to guarantee the installation is according to spec.
• Guarantee good PM practices and tools (schedule, budget control, issues, decisions, reporting, stakeholder management, ).
• Keep oversight of the contractor company that will build, install or test the equipment.
• Deliver all project documentation and close out of the project. Follow start up results to guarantee that the project deliverables were achieved.
• Deliver all projects within cost and timeline according to business strategies.
• PE is responsible to manage changes and document actions (CAPA’s, risk assessments, CGMP review, new document versions).

Skills

3+ years experience

Education

Master's Degree (mechanical/chemical engineering)

Job description

Thermo Fisher Scientific in Lombardy (Monza area) is seeking a Process Engineer to lead pharmaceutical process development projects. You will collaborate with clients, define design specs, and ensure GMP compliance throughout the project lifecycle.

The role requires a Master’s in mechanical or chemical engineering, 3+ years in GMP/GEP environments, and strong leadership and communication skills. English fluency is required; the position is on-site in Italy.