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.

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.