CQV Engineer

Jobtailor; Milano; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Jobtailor in Milano, Italy seeks a CQV Documentation Specialist to develop and execute commissioning/qualification documentation for pharmaceutical facilities and equipment. You will write protocols, perform field verifications, and generate summary reports at client sites while supporting CQV activities in demand. Strong English, attention to detail, and travel readiness are required.

Competenze

• BS or MS in a relevant science or engineering field, or equivalent hands-on experience.
• 2-3 years’ experience performing commissioning and/or qualification activities in an FDA regulated industry.
• Experience with facilities and equipment startup, walkdowns & troubleshooting, utilities, FAT/SAT, URS, IQ/OQ/PQ.
• cGMP leadership for CQV services delivery for Life Sciences clients.
• Excellent technical problem-solving and troubleshooting skills.
• Ability to work independently and build a project team.

Mansioni

• Develop documentation to support Commissioning, Qualifications, and Validation.
• Write and execute protocols, perform field verification, and prepare summary reports at client sites.
• Support documentation for CQV of pharmaceutical facilities, utilities, and equipment.

Conoscenze

Attention to detail

Multitasking

Independent work

English proficiency

Travel willingness

Problem solving

Formazione

BS or MS in science or engineering

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

Responsibilities

• Develop the documentation to support Commissioning, Qualifications, and Validation.
• Responsible for protocol writing and execution, field verification, and development of summary reports at client sites.
• Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.

Requirements

• High attention to detail.
• Ability to multi-task and take initiative to accomplish assigned tasks accurately.
• 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.
• Experience in facilities and equipment startup, walkdowns & 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 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.
• Familiarity with Baseline Guide 5 (Second Edition) is 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 is required.
• Available for travel in Italy and abroad.