CQV Engineer

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 weve challenged ourselves to do what others wouldnt. 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 isnt simply a goal. Its 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. Were not interested in how it used to be done. Were obsessed with how it will be done. Key Responsibilities:

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 2/3 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.

The compensation package offered ranges from 34000 to 45000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidates technical competencies and relevant professional experience.

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

34000 - 45000 a year

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1
Yearly Salary Salary: 34000 - 45000