CQV Lead (API)

Location: Onsite in Tipperary, Ireland

Salary: Hourly rate in EUR

Company

hirify.global is an employee-owned international engineering, architecture, project, and construction management firm delivering complex capital projects across life sciences, food and beverage, mission-critical, advanced manufacturing, energy, and environmental sectors.

What you will do

• Lead planning, coordination, and execution of commissioning, qualification, and validation activities for API manufacturing facilities and utility systems.
• Develop CQV strategies, validation plans, schedules, and resource requirements aligned with project and client objectives.
• Author, review, and approve VMPs, risk assessments, traceability matrices, commissioning test scripts, IQ/OQ/PQ protocols, and summary reports.
• Provide CQV leadership during design and constructability reviews, FATs, SATs, and system turnover.
• Coordinate Engineering, Automation, Quality Assurance, Manufacturing, Operations, and vendor teams.
• Manage deviations, change controls, CAPAs, root-cause investigations, inspections, audits, and project reporting.

Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Science, Life Sciences, or a related technical discipline.
• At least 10 years of Commissioning, Qualification, and Validation experience in pharmaceutical, biotechnology, or life sciences environments.
• Experience leading CQV teams on large-scale capital projects in API or bulk pharmaceutical manufacturing.
• Strong knowledge of GMP requirements and FDA, EMA, ICH, ISPE Baseline Guides, GAMP, 21 CFR Part 11, and Annex 11.
• Experience qualifying process equipment, clean utilities, facilities, and automation systems.
• Strong stakeholder management, communication, leadership, problem-solving, and prioritization skills.

Nice to have

• Experience with DeltaV, PCS, SCADA, or equivalent process control systems.

Culture & Benefits

• Employee-owned company with a focus on people, clients, and trade partners.
• Inclusive workplace centered on mutual respect, belonging, diversity, and equal participation.
• Commitment to corporate responsibility and sustainability.
• Reasonable accommodations are available during the recruitment process for candidates with disabilities.