The C&Q Lead is responsible for managing and overseeing all Commissioning & Qualification (C&Q) activities at a biopharma manufacturing facility, ensuring alignment with both industry regulations and project milestones. This leadership role will drive technical troubleshooting, resource planning, stakeholder reporting, and system readiness, while actively mentoring junior engineers.
Key Responsibilities
Lead and supervise all C&Q activities, collaborating directly with the on-site C&Q Lead.
Serve as the primary escalation contact for troubleshooting and resolving technical issues.
Perform system walkdowns and readiness reviews; confirm systems are prepared for IQ (Installation Qualification).
Ensure compliance with Good Engineering Practice (GEP) and Good Manufacturing Practice (GMP) standards across all activities.
Manage overall C&Q resource planning, including phased onboarding/offboarding in accordance with MC (Mechanical Completion) dates.
Publish weekly progress reports (Actual vs Planned) to project leadership and stakeholders.
Coordinate with Emerson Automation, vendors, Utilities team, and Regeneron quality and validation teams.
Support system handovers to operations, ensuring all issues are resolved and systems meet operational requirements.
Provide guidance and mentorship to junior C&Q engineers.
Experience Requirements
Minimum 10 years’ experience in C&Q within a regulated biopharma or pharmaceutical manufacturing environment.
Proven track record of leading C&Q programmes for multi-system, large-scale bioprocess facilities.
Experience managing integrated schedule coordination across multiple workstreams and vendors.
Technical Skills
Thorough knowledge of biopharma equipment, including bioreactors (USP), chromatography, filtration, CIP/SIP (DSP).
Proficiency in Piping & Instrumentation Diagrams (P&IDs), engineering drawings, functional design specifications, and technical documentation.
Familiarity with process automation platforms such as DeltaV, PLCs, and Emerson systems.
Experience with electronic qualification systems (ValGenesis preferred).
Soft Skills & Behaviours
Excellent leadership and communication skills, capable of engaging stakeholders at all project levels.
Strong analytical, problem-solving, and decision-making abilities.
Ability to manage competing priorities within a dynamic, multi-contractor environment
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