CQV CSV Engineer
Support the construction management and qualification of an ongoing project and additional expansion.
The project involves installation, commissioning and qualification of facilities, utilities, equipment and control systems associated with the expansion at the ATMP facility. It will involve tie ins to existing installation (electrical/CO2) IOQ of production equipment, centrifuges, CO2 Incubators, Isolators, Microscopes etc. for the manufacture a regenerative cell therapy product. There will be extensive piping, building services (HVAC), new utilities and extensions to existing utilities, together with an upgrade to the control system.
Develop and write C&Q documents following established standards
Performs and assists with execution of commissioning associated with the start-up, and qualification protocols.
Ensures projects are managed in conjunction with all regulatory requirements (Health & Safety, cGMP, construction, environmental etc.)
Performs walk-down and verification of system drawings (i.e., P&IDs, as-builts, etc.) Management of development and execution of IQ and OQ activities, Summary Reports, Risk Assessments, Specifications (URS), FATs / SATs.
Review/approve execution of the commission and qualification plans.
Review of all design deliverables including drawings, datasheets, specifications and engineering lists.
Point person for review for all associated vendor packages.
Liaise with Engineers in relation to construction readiness and a schedule for systems/equipment within areas of responsibility.
Minimum Qualifications And Experience
8+ years’ experience working in a similar role within an ATMP, Bio-Pharmaceutical or pharmaceutical environment and has successfully completed a number of start-ups.
Experience of Commissioning and Qualification in a project environment.
Hands on attitude, specifically functional testing of equipment and systems outlined above.
Bachelor’s Degree Engineering (or equivalent)
Experience of Thermal Mapping.
Experience of implementing systems in accordance with 21CFR Part 11 regulations i.e. Electronic Sigs & Electronic Records which also leads on to data Integrity & Audit Trail review.
Experience with Data Management Systems, OSI PI, OPC, Historians.
Knowledge of requirements for design, installation, commissioning, qualification of pharmaceutical Facilities, utilities and equipment.
Specific knowledge of cell therapy process.
Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
Strong understanding of pharmaceutical industry regulatory requirements.
Highly motivated with ability to work effectively with as part of a team or independently.
Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern CQV practices