Senior CQV Engineer (Pharmaceutical)

TL;DR

Senior CQV Engineer (Pharmaceutical): Leading commissioning, qualification, and startup activities for API manufacturing process trains within a major brownfield Pharmaceutical Project with an accent on safe and compliant delivery of process systems. Focus on executing FAT, SAT, IQ, OQ and managing the transition from construction to handover in a GMP environment.

Location: Onsite in Tipperary, Ireland

Company

hirify.global's Outsourced Technical Services (OTS) Department partners with global industry leaders to provide skilled professionals for technically challenging projects internationally.

What you will do

• Lead Commissioning & Qualification (C&Q) activities for API process trains.
• Execute and oversee FAT, SAT, Commissioning, IQ, OQ, and startup activities.
• Develop and execute commissioning and qualification documentation within Kneat.
• Coordinate punch list generation, tracking, and closure through to handover.
• Support PSSR/PSSER activities, risk assessments, change controls, deviations, and CAPAs.
• Interface with Operations, Quality, Engineering, Construction, and Automation teams.

Requirements

• Degree in Chemical, Process, Mechanical Engineering, or related discipline.
• 8+ years' experience in Pharmaceutical/API manufacturing projects.
• Proven experience delivering CQV on large capital or brownfield API projects.
• Strong knowledge of GMP manufacturing processes and regulatory requirements.
• Experience using Kneat for digital CQV execution.
• Experience with DeltaV systems, alarms, interlocks, and process control strategies.

Culture & Benefits

• Opportunity to contribute to exciting and technically challenging projects in Ireland and internationally.
• Excellent career development opportunities.
• Competitive benefits.
• Long-term assignments.