Validation Engineer

CAI

Milano, Italy

Hybrid

Who this role is best for

A natural match if you have 4–8 years of GMP-regulated pharmaceutical experience and expertise in CQV documentation.

Best fit for

Candidates with hands-on validation experience in pharmaceutical facilities and equipment
— “Minimum 4 – 8 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry.”
Professionals skilled in protocol writing and execution for CQV projects
— “Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.”
Individuals with deep knowledge of GMP-based validation and aseptic processing
— “Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.”

Things to consider

100% travel requirement may be a significant lifestyle adjustment
— “Available for travel in Italy and abroad 100%.”
Non-European candidates must have a valid residence permit for Europe
— “It is absolutely necessary, in order to apply, to be a European citizen or to hold a valid residence permit for Europe.”

How to stand out

Highlight experience with FAT/SAT, URS, and design reviews in your resume
— “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.”
Emphasize your ability to lead and guide CQV services in a GMP context
— “Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.”
Demonstrate technical problem-solving skills in validation scenarios
— “Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues”

Pace · SteadyCollaboration · MediumAutonomy · MediumDecision Impact · Team

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

Developed documentation for Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment

Typical background

BS or MS in a relevant science or engineering field4-8 years of experience in FDA regulated industry

Skills & requirements

Required

CommissioningQualificationValidationGmp-regulated EnvironmentPharmaceutical Industry ExperienceProtocol WritingExecutionSummary Report Development

Preferred

Fat/satURSP&idsIq/oq/pqsGeneration & Execution

Stack & domain

CommissioningQualificationValidationProtocol WritingField VerificationSummary ReportsCgmpTechnical Problem-solvingTroubleshootingProject Technical IssuesBS Or MS In A Relevant Science Or Engineering FieldAttention To DetailMulti-taskingInitiativeCommunicationTeamworkLeadershipLife SciencesMission Critical IndustriesPharmaceutical IndustryGmp-regulated Environment

About the role

Original posting from CAI via Lever

CAI Overview:
Are You Ready?
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.
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)
Compensation:
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.

Source: CAI careers (Lever)