Commissioning & Qualification Lead/Project Manager to provide technical support and leadership for new Process Area CAPEX project.Essential Duties and Responsibilities include, but are not limited to, the following:• Prior to commissioning drive and track deliverables to completion – engineering and qualificationdocumentation, FAT/SFAT executions, VTOPS reviews, Asset Builds etc.• Support the handover of systems to operations by ensuring all issues are resolved and systemsmeet operational requirements.• Oversee onsite setup and shakedown of new systems and equipment to ensure functionality andreadiness for commissioning.• Lead and oversee the execution of commissioning and qualification (CA, CTP, IQ, OQ, PQ)activities as per pre-approved protocols.• Act as the primary point of escalation for troubleshooting and resolving issues during C&Qexecution.• Provide hands-on support to the C&Q team in identifying and addressing system issues.• Collaborate with cross-functional teams, including engineering, validation, and operations, toensure smooth execution of C&Q tasks.• Ensure all commissioning and qualification activities comply with GEP and GMP standards.• Conduct system walkdowns and support readiness reviews to verify systems are ready for C&Q.• Communicate progress, challenges, and resolutions to stakeholders and project leadership.• Coordinate with vendors and contractors to address equipment-specific issues and ensurecompliance with project specifications.Education and experience:• Minimum of 8 years of experience in commissioning and qualification in a regulated biopharma or pharmaceutical environment.• Demonstrated expertise in troubleshooting and problem-solving during C&Q execution.• Strong knowledge of biopharma equipment and systems (e.g., bioreactors, chromatography columns, filtration units, utilities).• Proficiency in interpreting engineering drawings, P&IDs, and technical documentation.• Familiarity with process control systems (e.g., DeltaV, PLCs) and automation systems.• Excellent leadership and communication skills to manage teams and interface with stakeholders.• Strong analytical and problem-solving abilities to resolve technical issues efficiently.• Ability to work under pressure and manage multiple priorities in a fast-paced environmentApply today or contact Róisín Vaughan at or