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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
Other Requirements:
Expertise in Microsoft Word and Excel
Excellent oral and written English are required.
Available for travel in Italy and abroad.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
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Full Time
Social & Legal Services
$84k-97k (estimate)
01/31/2024
06/22/2024
caiglobal.org
NEW YORK, NY
50 - 100
1979
BARBARA CICATELLI
$10M - $50M
Social & Legal Services
CAI is a global non-profit organization that tackles the toughest issues facing underserved populations today. Since 1979, we have worked to improve the quality of health care and social services delivered to vulnerable populations worldwide. At CAI we develop and deliver a wide range of educational training and technical assistance services to health and social service providers. Our innovative staff help organizations build their capacity to better coordinate their services and more effectively serve their clients. From reproductive health and family planning to HIV/AIDS prevention and subst...ance abuse, our mission remains the same -- to use the transformative power of education and research to foster a more aware, healthy, compassionate and equitable world.
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The job skills required for CQV Engineer include Leadership, Problem Solving, Initiative, Troubleshooting, etc. Having related job skills and expertise will give you an advantage when applying to be a CQV Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by CQV Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for CQV Engineer positions, which can be used as a reference in future career path planning. As a CQV Engineer, it can be promoted into senior positions as a Validation Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary CQV Engineer. You can explore the career advancement for a CQV Engineer below and select your interested title to get hiring information.