HVAC CQV Engineer: Clean Rooms & GMP Validation

DPS Group; Dublin; On-site; EUR 65,000 - 95,000; Full time

Job summary

DPS Group is seeking a CQV professional to support the development and execution of commissioning and qualification testing for the Sterile Drug product facility. You will ensure documentation, schedules and compliance with EU and FDA regulations.

The role involves working with cross-functional teams and external vendors to deliver CQV activities, EMPQ protocols, data review and deviation management, with a strong emphasis on safety and quality.

Qualifications

• Demonstrable capacity to implement a project CQV strategy from initiation to completion.
• Demonstrable experience as part of a diverse team of CQV professionals/contractors delivering tasks safely, with quality and on time.
• Experience in CQV of Drug Substance/Drug Product sterile manufacturing HVAC & Clean Rooms with integrated automation platforms.
• Experience using digital validation execution systems (e.g. Kneat or Valgenesis) is an advantage but not essential.
• Strong communication skills both written and oral.
• Strong problem-solving and analytical skills.
• Ability to work within a cross-functional team.

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 and Global procedures.
• 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.
• Deviation management associated with the assigned HVAC & Clean Rooms.
• Preparation of validation summary reports

Skills

CQV planning

Documentation execution

Cross-functional teamwork

Analytical skills

Communication skills

Education

Bachelor's degree in scientific/engineering

Tools

Kneat

Valgenesis

Job description

DPS Group is seeking a CQV professional to support the development and execution of commissioning and qualification testing for the Sterile Drug product facility. You will ensure documentation, schedules and compliance with EU and FDA regulations.

The role involves working with cross-functional teams and external vendors to deliver CQV activities, EMPQ protocols, data review and deviation management, with a strong emphasis on safety and quality.