Commissioning & Qualification Lead

About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. PSC Biotech is hiring for a project in Limerick a Commissioning & Qualification Lead. Commissioning & Qualification Lead 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 qualification

documentation, FAT/SFAT executions, VTOPS reviews, Asset Builds etc.

• Support the handover of systems to operations by ensuring all issues are resolved and systems meet operational requirements.
• Oversee onsite setup and shakedown of new systems and equipment to ensure functionality and readiness 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&Q execution.
• 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, to ensure 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 ensure compliance with project specifications.

Requirements Education and experience:

• Minimum of 10 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 environment