CQV Engineers (HVAC & Black Utilities)

Women Building Bio; Connacht; On-site; EUR 60,000 - 100,000; Full time

Job summary

Women Building Bio is seeking a CQV Engineer for a client in Ireland, based in County Limerick, on a 12-month contract with potential extension. The role targets candidates with strong CQV background in HVAC or Black/Grey Utilities.

You will deliver CQV activities for a pharmaceutical manufacturing facility, develop and execute protocols and validation plans, and ensure compliance with GMP, GDP and regulatory standards while coordinating with cross-functional teams and external vendors.

Qualifications

• CQV experience in pharmaceutical manufacturing.
• Strong background in HVAC or Black/Grey Utilities.
• Familiarity with GMP, GDP and regulatory expectations.

Responsibilities

• Deliver CQV activities within a pharmaceutical manufacturing facility.
• Develop, review and execute commissioning/qualification documents.
• Support commissioning, qualification and troubleshooting of facility and utility systems.
• Ensure CQV activities align with GMP, GDP and regulatory requirements.
• Manage deviations, punch-lists and non-conformances.
• Collaborate with Engineering, Quality, Validation, Operations and external vendors.
• Provide technical input into project design, installation and qualification activities.
• Maintain CQV documentation in line with Good Documentation Practice.
• Support risk assessments, change controls and impact assessments.
• Participate in walkdowns, FAT/SAT and handover of equipment/systems.
• Proven CQV experience with Black Utilities or HVAC systems.
• Experience qualifying utility systems within GMP pharma environment.

Skills

CQV

HVAC

GMP

GDP

Validation

Documentation

Job description

I am currently on the lookout for a CQV Engineer to join a client based in County Limerick. This is an initial 12-month contract, with the chance of an extension.
There are several positions available, but they are looking for people with a strong background in HVAC or Black/Grey Utilities. If you have experience with both that would be excellent.

Key Responsibilities

• Deliver Commissioning, Qualification & Validation (CQV) activities within a pharmaceutical manufacturing facility.
• Develop, review and execute commissioning and qualification documentation, including protocols, test scripts, reports and validation plans.
• Support commissioning, qualification and troubleshooting of pharmaceutical facility and utility systems.
• Ensure all CQV activities are conducted in accordance with GMP, GEP and relevant regulatory requirements.
• Manage and resolve deviations, punch-list items, non-conformances and qualification issues.
• Work closely with Engineering, Quality, Validation, Operations and external vendors/contractors.
• Provide technical input into project design, installation, commissioning and qualification activities.
• Maintain accurate and compliant CQV documentation in line with Good Documentation Practice (GDP).
• Support risk assessments, change controls and impact assessment associated with CQV activities.
• Participate in system walkdowns, FAT/SAT activities and equipment/system handover.
• Proven CQV experience with either Black Utilities (such as compressed air, process gases, cooling water, chilled water, boilers, steam and associated utility systems) or HVAC systems (such as cleanrooms, air handling units, environmental monitoring and associated qualification activities).
• Experience commissioning and qualifying utility systems within a GMP pharmaceutical manufacturing environment.