Validation Engineer

CAI; Bologna; In loco; EUR 45.000 - 57.000; Tempo pieno

Descrizione del lavoro

CAI is seeking a CQV Engineer to join our Italian operations. The role develops documentation to support Commissioning, Qualifications, and Validation, including protocol writing, field verification, and summary reports at client sites.

Required are 4–8 years of FDA-regulated CQV experience, knowledge of GMP processes, and strong English. Expect travel in Italy and abroad, with compensation €45,000–€57,000 gross per year.

Competenze

• 4–8 years’ experience performing commissioning/qualification in an FDA-regulated industry.
• Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), FAT/SAT, URS, IQ/OQ/PQs.
• Provide cGMP leadership for CQV services for Life Sciences clients.
• Excellent technical problem-solving skills and ability to work independently.

Mansioni

• Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities and equipment.
• Responsible for protocol writing and execution (field verification) and development of summary reports at client sites.
• Manage C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
• Support onsite and offsite activities such as FATs, SATs, IOQ and PQ Executions and System Walkdowns.

Conoscenze

Attention to detail

Multi-tasking

Problem solving

Independent work

Team collaboration

English proficiency

Formazione

BS or MS in a relevant science or engineering field

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

CAI Overview

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years.

Are You Ready?

Our approach is simple because our Purpose informs everything we do:

• We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:

• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing

expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

It is absolutely necessary, in order to apply, to be a European citizen or to hold a valid residence permit for Europe.

We are only looking for candidates with experience in the pharmaceutical industry, specifically within a GMP-regulated environment.

Position Description

We are now seeking a CQV Engineer to join our growing operations in Italy. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.

The role of a CQV Engineer in CAI is to:

• Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
• Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.

Position Requirements

• High attention to detail
• Ability to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
• Minimum 4 – 8 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
• Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
• Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
• deadlines
• Ability to work independently, while quickly building and nurturing a project team
• Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
• Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
• Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
• Familiarity with Baseline Guide 5 (Second Edition) a plus
• Expected skills: Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge
• Expertise in Microsoft Word and Excel
• Excellent oral and written English are required.
• Available for travel in Italy and abroad 100%.

The compensation package offered ranges from €45.000 to €57,000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience.

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

€45,800 - €57,000 a year

The compensation package offered ranges from €45.000 to €57,000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience.