Headcount Solutions is sourcing an E&I Handover Engineer for our multinational client’s biotech facility. Reporting to the E&I Suite Team Lead, this engineer will be required to work closely with a cross-functional team and coordinate activities between Design, Construction, Process, Technical Operations, C&Q, IPT and QA.
· Confirm SAT’s are suitably completed and category 1/2/3 items are capable of being closed by the design team.
· Review VTOPs , CTOPS for accuracy and completion.
· Review FAT snags are addressed, completed.
· Walk and confirm the installation /equipment is as per the supplied design drawings and documents.
· Confirm all electrical /I+C connection drawings are highlighted and walked down without issues.
· Confirm the equipment has been built correctly, fully tested, components installed as per design.
· Confirm the system construction has been documented and As-built/Redlined docs have been or are in the process of being updated in CAD.
· Coordinate the design effort with the contract engineering firm and ensure compliance to local & Global Standards.
· Facilitate engineering and user requirements for the facility and ICT systems.
· Coordinate review of design material from the owner’s side including Layout reviews, P&ID/AF&ID reviews, Process Descriptions, Job Specifications, and PO’s/Data Sheets.
· Review C&Q plans/protocols as related to Suite systems.
· Assist in the coordinating of C&Q start-up activities , punch list follow-up.
· Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
· Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
· Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
· Delivery of the agreed milestones on the schedule within budget constraints.
· Delivery of stakeholder agreed scope for Suite facilities to Commissioning Qualification or as appropriate Process Qualifications.
· Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
· Minimum of 5 years’ experience similar role in Pharmaceutical Facility/ Building/Utilities systems within Pharmaceutical industry.
· Experience of design and construction/handover of pharmaceutical process and building facilities for pharmaceutical facilities.
· Working knowledge of standards as they apply in biotechnology processes industries and a working knowledge of FDA and EU regulations is preferred.