CQV Engineer

PE Global; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

PE Global is recruiting a CQV Engineer (HVAC) for a leading pharmaceutical facility in Dublin. This is a 12-month contract role.

The candidate will develop and execute CQV documentation for HVAC & Clean Rooms, ensure compliance with GMP, EU and FDA regulations, and coordinate with vendors to deliver CQV milestones on time.

Qualifications

• Bachelor's degree in a scientific/technical/engineering discipline is required.
• 3–5 years of C&Q experience including documentation and execution.
• Experience with CQV for HVAC & Clean Rooms in pharma/regulated environments preferred.

Responsibilities

• Develop and execute CQV testing documentation for HVAC & Clean Rooms.
• Meet project deliverables for safety, CQV schedule, and quality of documentation.
• Ensure GMP Clean Rooms, Cold Rooms and HVAC systems are tested per GMP and EU/FDA regs.
• Manage deviations and assess CQV risks with action plans.
• Coordinate with vendors/contractors during CQV execution.
• Execute EMPQ protocols and support lab testing and data review.
• Prepare validation summary reports.

Skills

Communication skills

Problem-solving

Cross-functional teamwork

Analytical skills

Education

Bachelor's degree in a scientific/technical/engineering discipline

Tools

Kneat

Valgenesis

Job description

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

Responsibilities:

• Development and execution of CQV testing documentation for HVAC & Clean Rooms for the Sterile Drug product facility.
• Responsible for meeting key project deliverables for safety, CQV schedule management and quality of project related documentation/electronic records for HVAC & Clean Rooms assigned.
• Responsible for ensuring GMP Clean Rooms, Cold Rooms and HVAC Equipment systems are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Deviation management associated with the assigned HVAC & Clean Rooms.
• Risk Management – Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.
• Coordination with vendors & contractors during execution of Commissioning & Qualification documents.
• Execution of Environmental Monitoring Performance Qualification (EMPQ) protocols in compliance with site procedures and safety procedures for the SDP manufacturing facility.
• Performance of sampling and liaising with the laboratory to support testing of the EMPQ samples.
• Review of laboratory data and data analysis.
• Preparation of validation summary reports

Education and Experience:

• Bachelor’s degree in a scientific, technical or engineering discipline
• 3-5 years of C&Q experience to include both documentation preparation and execution.
• Demonstratable capacity to implement a project CQV strategy, effectively execute the CQV testing approach for assigned from initiation to completion.
• Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.
• Experience in CQV of Drug Substance/Drug product sterile manufacturing HVAC & Clean Rooms with integrated automation platforms.
• Experience using a digital validation execution system (e.g. Kneat or Valgenesis) is an advantage but not essential.
• Strong communication skills both written and oral.
• Strong problem-solving & analytical skills.
• Ability to work within a cross-functional team.

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