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Senior Process Engineer IV

Company: Mindlance
Location: Vacaville
Posted on: May 8, 2022

Job Description:

Role: Senior Process Engineer IV
Location: Vacaville, CA
Duration: 12 month (Possible Extension)

Job Description:
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 in Vacaville, including the responsibilities listed below.

RESPONSIBILITIES
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, Client 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, Client 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.

QUALIFICATIONS
- 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.

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."

Keywords: Mindlance, Vacaville , Senior Process Engineer IV, Engineering , Vacaville, California

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