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As a Software Engineer on the Identity Infrastructure Engineering team, you'll create and operate security tools and infrastructure for multi-cloud environments.
CQV Engineer
📅 Oct 30, 2024
📍 🇮🇹 Italy - Hybrid💰 €34k - €45k / year🎹 Mid-level💻 Software Engineer📢 🇬🇧 English Required💼 Full-Time
Protocol Writing And ExecutionField VerificationCgmpFDA-regulated Industry
📜 Description
- Develop CQV documentation for pharmaceutical facilities, utilities, and equipment.
- Write and execute protocols, perform field verification, and prepare summary reports.
- Manage the C&Q documentation and execution lifecycle from SLIA generation through OQ completion.
- Support onsite and offsite FATs, SATs, IOQ and PQ executions, and system walkdowns.
- Provide cGMP guidance and technical support for CQV service delivery to life sciences clients.
🛠️ Requirements
- Bachelor’s or master’s degree in a relevant science or engineering field, or equivalent hands-on experience.
- Minimum 4–8 years’ experience performing commissioning and/or qualification activities in an FDA-regulated industry.
- Experience with equipment startup, walkdowns, troubleshooting, utilities, building automation, or pharmaceutical manufacturing processes and equipment.
- Knowledge of FAT/SAT, URS, design reviews, P&IDs, and IQ/OQ/PQ generation and execution.
- Strong technical problem-solving and troubleshooting skills; able to work independently and manage multiple tasks.
- High attention to detail, initiative, and ability to build and nurture a project team.
- Proficiency in Microsoft Word and Excel; excellent oral and written English.
- Availability to travel in Italy and abroad.
- Support qualification activities involving isolators, VHP cycles, and pharmaceutical manufacturing processes.
Full job description
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 €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.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
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