CQV Engineer

Atrium; Leinster; On-site; EUR 65,000 - 85,000; Full time

Job summary

Atrium is seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing facilities and equipment. The successful candidate will play a key role in ensuring systems, utilities, equipment, and processes are commissioned and qualified in compliance with GMP requirements.

The role involves executing CQV across equipment, utilities, and facilities, developing IQ/OQ/PQ documentation, and coordinating with multidisciplinary teams

Qualifications

• Degree in Engineering or Life Sciences or equivalent.
• CQV/Validation/Commissioning experience in pharma/biotech/medical devices.
• Strong GMP knowledge and validation lifecycle principles.
• Experience qualifying process equipment, cleanrooms, and manufacturing systems.
• Knowledge of risk-based validation approaches and change control processes.
• Excellent documentation and stakeholder management skills.
• Ability to work effectively within multidisciplinary project teams.
• Experience with sterile manufacturing facilities and clean utilities.
• Experience with DeltaV, MES, and CSV.

Responsibilities

• Execute CQV activities across equipment, utilities, and facilities.
• Develop and review IQ, OQ, PQ protocols and reports.
• Support commissioning for process equipment, clean utilities, HVAC, and facilities.
• Ensure GMP/GDP and regulatory compliance.
• Perform risk assessments and support CAPA investigations.
• Coordinate with engineering, manufacturing, quality, and project teams.
• Review vendor documentation, FATs, SATs, and turnover packages.
• Support project schedules and ensure timely qualification activities.
• Participate in audits and inspections as required.

Skills

CQV experience

GMP knowledge

Documentation

Risk assessment

CAPA

Stakeholder management

Cross-functional teamwork

Pharma/Biotech/Medical devices

Clean utilities understanding

Education

Engineering or Life Sciences degree

Tools

DeltaV

MES

CSV

Job description

Atrium is seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing facilities and equipment. The successful candidate will play a key role in ensuring systems, utilities, equipment, and processes are commissioned and qualified in compliance with GMP requirements.

Key Responsibilities

• Execute Commissioning, Qualification, and Validation (CQV) activities across equipment, utilities, and facilities.
• Develop and review qualification documentation, including IQ, OQ, PQ protocols and reports.
• Support commissioning activities for process equipment, clean utilities, HVAC systems, and facilities.
• Ensure compliance with GMP, GDP, and regulatory requirements.
• Perform risk assessments and support deviation investigations and CAPA activities.
• Coordinate with engineering, manufacturing, quality, and project teams to ensure successful project delivery.
• Review vendor documentation, FATs, SATs, and turnover packages.
• Support project schedules and ensure qualification activities are completed on time.
• Participate in audits and inspections as required.

Experience required

• Degree or equivalent qualification in Engineering, Life Sciences, or a related discipline.
• Previous experience in a CQV, Validation, or Commissioning role within the pharmaceutical, biotech, or medical device industry.
• Strong knowledge of GMP regulations and validation lifecycle principles.
• Experience qualifying process equipment, utilities, cleanrooms, and manufacturing systems.
• Knowledge of risk-based validation approaches and change control processes.
• Excellent documentation, communication, and stakeholder management skills.
• Ability to work effectively within multidisciplinary project teams.
• Sterile manufacturing, biologics, vaccines, or API facilities.
• Clean utilities including WFI, Clean Steam, Purified Water, and compressed gases.
• DeltaV, MES, automation, or computerized system validation (CSV).
• Experience supporting large capital projects and facility start-ups.

Why to apply

• Opportunity to work on leading pharmaceutical and biotechnology projects.
• Collaborative and innovative project environment.