4308 Process Engineer IV
The Facilities and Engineering (F&E) seeks a competent and energetic Process Engineer/Senior Process Engineer, who will report to the F&E Project Delivery Team.
The engineer will provide process/mechanical engineering expertise, leadership and support to the GMP manufacturing operations and equipment, including the responsibilities listed below.
Provide process/mechanical engineering on capital and expense projects for GMP production systems (including but not limited to bioreactors, media and buffer prep and hold tanks, centrifuge, chromatography skids and columns, UF/DF skids, CIP/SIP skids, parts washers, autoclaves, utilities and bulk freeze/thaw tanks) by driving and managing the projects from project initiation through conceptual/ basic/ detailed design, build/qualification and closure.
This will include the following:
Lead and complete the hygienic design for engineering, operational and safety aspects with a multi-disciplinary team (manufacturing, frontline, automation, validation, quality, facilities and SHE), which includes engineering design reviews (EDR), process hazard analysis (PHA), design and installation checklists (D&I), maintenance master data (MMD), and change requests (CRs).
Complete engineering designs and calculations per engineering design codes, Engineering Manual (EM), master specifications, and engineering standards and practices.
Develop and maintain engineering deliverables such as P&IDs, process flow diagrams (PFDs), design drawings, master specifications, technical bid evaluation, vendor print reviews, design review, equipment lists, and test protocols.
Support and approve project documentation such as user requirement specification (URS), project execution plan (PEP), basic of design (BOD), technical bid evaluation (TBE), and quality deliverables [system impact assessment (SIA), criticality assessment (CA) and design qualification (DQ)].
Support project management with schedules, budget, request for quotation (RFQ), request for information (RFI), contractor bid packages, statements of work (SOW), and credit applications.
Lead and complete FAT, SAT, commissioning, and IQ.
Support debug, operational and performance qualification, and handover to operations.
Develop and approve construction packages (ISOs, pressure test, passivation, flushing, LOTO, etc.) and field verify construction for mechanical completion.
Support project management with contractor supervision, construction supervision, business processes, work notifications/orders, punch-list, turnover, and closure.
Complete project closure with filing of as-built drawings, IQ supporting documents and project support documents, TOPs, CR completion, D&I handover and lessons learned.
Provide directions to contract personnel and approve their work.
Collaborate with Global Engineering on major facility modifications, process expansions and new construction.
Perform project management role on small projects.
Provide process/mechanical engineering expertise and support to manufacturing, frontline, automation, validation, facilities on GMP production equipment, including investigations, DMS, CAPA’s, audits, inspections, permits, STARI, maintenance master data, and other technical requests.
Provide technical and procedural guidance to junior engineers.
Participate in and/or lead engineering-related site or network improvement initiatives.
Collaborate with peers in continuous improvement of technical infrastructure including standards, practices, specifications, procedures, and business processes.
Bachelor of Science in Chemical Engineering, Mechanical Engineering or related Engineering.
4 to 8+ years of GMP engineering experience.
Experience with process/mechanical hygienic engineering design, large project execution, project management, change control, and qualification in the biotechnology and/or pharmaceutical industry.
Experience with computer systems such as Google suite (gMail, Calendar, Drive), Word and Excel, and familiar with change control systems and SAP.
Must be highly self-motivated and able to work independently or part of a multidisciplinary team with minimal supervision.
Must have excellent organization and communication skills, and be self-managed to prioritize and produce high quality and accurate work in a timely manner.
Ability to communicate information accurately and concisely, both verbally and in writing, to a diverse audience.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.