Validation Engineer with expertise in isolators and VHP Cycle development.

Commissioning Agents Inc; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading engineering firm in Italy is seeking a Validation Engineer to support documentation for commissioning and validation of pharmaceutical facilities. The role involves developing protocols, managing the C&Q documentation lifecycle, and providing cGMP guidance. Applicants should have a BS or MS in relevant fields and 3-5 years of experience, along with strong problem-solving skills and proficiency in Microsoft Office. Availability for travel throughout Italy is required.

Competenze

• 3–5 years of experience in commissioning and/or qualification activities in FDA-regulated industry.
• Strong understanding of life science manufacturing processes.
• Excellent oral and written English skills.

Mansioni

• Develop protocols for validation, execution, and reporting at client sites.
• Support documentation for commissioning, qualification, and validation.
• Manage the C&Q documentation lifecycle from SLIA to OQ completion.

Conoscenze

cGMP knowledge

Technical problem-solving

Microsoft Word proficiency

Microsoft Excel proficiency

Team building

Formazione

BS or MS in a relevant science or engineering field

Strumenti

FAT/SAT

WFI

RO

HVAC

P&ID

Descrizione del lavoro

We are now seeking a Validation Engineer to join our growing operations in Italy. The Validation Engineer develops the documentation to support commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.

Key Responsibilities

• Develop protocols for validation, execution, and reporting at client sites.
• Support documentation for commissioning, qualification, and validation of facilities and equipment.
• Write and execute isolation qualification protocols, VHP cycle development, and GMP‑based qualification protocols.
• Manage the C&Q documentation lifecycle from SLIA generation through to OQ completion.
• Support onsite and offsite activities such as FATs, SATs, IOQ, PQ executions, and system walkdowns.
• Provide cGMP leadership and guidance for the integration and delivery of validation services for Life Sciences clients.
• Proactively identify, troubleshoot, and resolve technical issues related to commissioning and qualification activities.

Requirements

• BS or MS in a relevant science or engineering field, or equivalent hands‑on experience.
• Minimum 3–5 years of experience in commissioning and/or qualification activities in an FDA‑regulated industry.
• Experience with facilities and equipment startup, walk‑downs, utilities (WFI, RO, HVAC), building automation, FAT/SAT, URS, design review, P&ID, IQ/OQ/PQ generation and execution.
• Strong cGMP knowledge, Microsoft Word and Excel proficiency.
• Excellent technical problem‑solving and troubleshooting skills with a solid understanding of typical project deadlines.
• Ability to work independently, build and nurture a project team, and manage the C&Q documentation lifecycle.
• Proficient in life science manufacturing processes such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent.
• Excellent oral and written English skills.
• Availability for travel throughout Italy and occasional European travel; valid permit to stay in Italy.
• High attention to detail and ability to multitask and take initiative to accomplish assigned tasks accurately by established deadlines.

Equal Opportunity Statement

La selezione rispetta il principio delle pari opportunità (l. 903 / 77).