CQV Engineer

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.

#J-18808-Ljbffr