CAI

Operational readiness consulting for pharma

CQV Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeMilan, Metropolitan City of Milan, Italy€34k - €45k /yr

About the Job

Requirements

High attention to detail and the ability to multitask and take initiative to complete assigned tasks accurately.
A Bachelor of Science or Master of Science in a relevant science or engineering field, or equivalent years of hands-on experience.
At least 4 years of experience performing commissioning and/or qualification activities in an FDA-regulated industry.
Strong technical problem-solving and troubleshooting skills, with knowledge of typical project technical issues.
Ability to work independently and quickly build and nurture a project team.
Proficiency in life science manufacturing processes, such as biotechnology, aseptic processing, aseptic fill/finish, oral solid dosage, or gene therapy, or equivalent experience.
Knowledge of isolator qualification protocol execution and reporting, vaporized hydrogen peroxide cycle development, and good manufacturing practice.
Expertise in Microsoft Word and Excel.
Excellent oral and written English.
Availability to travel in Italy and abroad.

Responsibilities

Develop documentation supporting commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.
Write and execute protocols, perform field verification, and develop summary reports at client sites.
Provide cGMP leadership and guidance for the integration and delivery of commissioning, qualification, and validation services for life sciences clients.
Manage the commissioning and qualification documentation and execution lifecycle from SLIA generation through OQ completion.
Support onsite and offsite activities, including factory acceptance tests, site acceptance tests, installation/operational qualification and performance qualification executions, and system walkdowns.

Desired Qualifications

Experience with facilities and equipment startup, walkdowns and troubleshooting, utilities such as WFI, RO, and HVAC, building automation, or other pharmaceutical manufacturing processes and equipment.
Experience with factory acceptance tests, site acceptance tests, user requirements specifications, design reviews, P&IDs, IQ/OQ/PQs, and generation and execution activities.
Familiarity with Baseline Guide 5, Second Edition.

Salary Range: 34402 to 45000 (Currency: EUR) (Pay period: per-year-salary)

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)

CAI

CQV Engineer

About the Job

Requirements

Responsibilities

Desired Qualifications

About the Company

CAI

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