Senior Process Engineer IV
Posted on: May 8, 2022
Role: Senior Process Engineer IV
Location: Vacaville, CA
Duration: 12 month (Possible Extension)
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
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
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
- 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
- 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
- Participate in and/or lead engineering-related site or network
- 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
- 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 -
Keywords: Mindlance, Vacaville , Senior Process Engineer IV, Engineering , Vacaville, California
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