CQV Engineer

PE Global; South Dublin; On-site; EUR 75,000 - 105,000; Full time

Job summary

PE Global is recruiting a CQV Engineer for a leading biotech company in Dublin South on a 12-month contract. The role focuses on commissioning, qualification and validation across capital and equipment lifecycle projects, with emphasis on GMP compliance and safety.

The ideal candidate will have 6+ years in validation/engineering, a third-level degree in engineering or science, and strong experience in pharmaceutical/biotech environments, including sterile processes.

Qualifications

• 6+ years experience in validation, commissioning and qualification management.
• Technical degree at third level in engineering or science.
• Experience in pharmaceutical/biotech validation and GMP compliance.
• Risk-based approach to commissioning and qualification.
• Experience with sterile/biotech equipment preferred.
• Knowledge of safety, GMP and environmental regulations.
• Ability to work in cross-functional teams.

Responsibilities

• Provide validation support across full lifecycle from design to qualification.
• Coordinate qualification activities for equipment and utility systems.
• Develop URS, QRAES and validation plans.
• Prepare and review FAT, SAT, IOQ, PQ protocols.
• Ensure safe startup and GMP compliance.
• Liaise with engineering, manufacturing and vendors.
• Support regulatory inspections and RTQs.
• Maintain SOPs and change control adherence.

Skills

CQV engineering

Validation management

GMP knowledge

Biotech equipment

Education

Engineering or science degree

Job description

PE Global is currently recruiting for a CQV Engineer on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

Overview:

Commissioning, Qualification and Validation (CQV) engineer for various capital and Equipment / Clean Utilities lifecycle projects joining a dynamic team. Ensure the activities are completed safely, as per schedule and in compliance with GMP and Quality Requirements. This role will be responsible for equipment validation in Sterile Fill Finish to ensure the maximum levels of performance and compliance are maintained.

Responsibilities:

• Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process from initial design through qualification to validation maintenance (eg. Periodic review)
• Coordinates the qualification activities and maintain Equipment and utility systems in a validated state
• Development or qualification approaches and equipment family strategies
• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
• Development and approval of C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQ’s, PQ’s etc. for the Vial and Syringe filling, formulation, inspection and utility areas in line with GMP’s, regulatory requirements and corporate standards.
• Ensures Startup of equipment/utilities is completed in a safe and coordinated manner. Ensures the safe startup of equipment and utilities.
• Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
• Support NPI introductions to equipment
• Assist in the development and improvements of the equipment validation lifecycle process while ensuring continued compliance to all necessary regulations.
• Participate in regulatory inspections, regulatory filings and RTQ’s (response to questions).
• Update and maintain Standard Operating Procedures (SOP's) in accordance with site and corporate requirements.
• Take ownership for quality compliance in all activities you are responsible for, Ensuring approaches are aligned with current guidelines (ICH/ASTM)
• Ensure the site change control procedure is adhered to.

Education / Experience:

• 6+ years experience in Science, Engineering or Validation, Commissioning and Qualification Management
• Technical qualification at third level or equivalent in Engineering or science.
• Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects
• Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product.
• Knowledge of safety, GMP and environmental regulatory requirements.
• Participate, when required, as a member of a multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team or NPI regulatory marketing applications.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland