CQV Engineer Staff II
Job Location:
Monthly Salary:
Posted on:
5 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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.
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)
34402 - 45000 a year
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.
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:
Staff IC
About Company
CAI helps organizations leverage technology, people, and processes to solve business problems, enable savings, and spur innovation.
