C
C AgentsCQV Engineer
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Before you apply
Salary€34k – €45k
LocationMilano
Work modehybrid
Typefull-time
SeniorityMid
Experience4–8 yrs
DepartmentEurope Life Sciences, South Europe
Company size501–1,000 people
PostedOct 30, 2024 · 2y ago
Verified live1d ago
May no longer be actively hiring
Posted by the company on Oct 30, 202477% of this company's open roles have been listed for 90+ days
At a glanceSummarised by Seekless from the posting.
High attention to detail
Ability to multi-task and take initiative to accomplish assigned tasks accurately
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
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
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
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
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
Familiarity with Baseline Guide 5 (Second Edition)
Available for travel in Italy and abroad
Skills
Microsoft Word
Microsoft Excel
About the role
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.
Responsibilities
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.
Requirements
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.
Nice to have
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 €34,000 to €45,000 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.
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