Biotech Process Engineer Jobs in California (NOW HIRING)

Introduction
Visium Resources has been asked to identify qualified candidates for this Senior Process Engineer position. This position is a direct hire which is expected to be on-site in Thousands Oaks, CA. This role will require work on the design, project execution and commissioning of process systems in the biopharmaceutical industry. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers

Responsibilities

* Provide technical guidance into the design, project management, commissioning and start-up of equipment and facilities, for upgrades, renovations and expansions of client facilities and processes.

* Support project execution from Feasibility through to project completion/handover, including all project stages such as:

o          Feasibility

o          Concept Design, Basic Design, Detailed Design

o          Procurement

o          Construction

o          Project Monitoring/Governance

o          Commissioning & Qualification

* Prepare/perform/review process engineering drawings, calculations, whether as part of engineering design or as part of verification of calculations of vendors/client/other consultants, or Junior Engineers at our client. Drawings may include PFDs, P&IDs as well as others. Calculations may include heat exchanger, pump, piping, control valve sizing, heat and mass balances, as well as other engineered calculations. 

* Prepare/review technical specifications and data sheets for various equipment, instrumentation, and systems (such as vessel data sheets, etc).

* Review technical documentation such as SDS/HDS, layouts, manuals, datasheets.

* Manage other engineering design firms, equipment vendors, construction firms, and internal/external stakeholders as required to execute projects.

* Integrate safety into the design and execution of all projects (HAZOP reviews, PHSRs, design reviews with EHS representatives).

* Prepare/review User Requirements Specifications (URS)

* Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), as well as support execution of Commissioning & Qualification.

* Prepare/review automation sequences, as required for Process Automation, such as Functional Specifications, Valve & Alarm Matrices.

* Coordination with other engineering disciplines and other cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).

* Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.

* Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.

* Travel may be occasionally required for meetings with the client and equipment fabrication vendors or Factory Acceptance Testing (FATs).

* Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.

* Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.

* Visit construction and installation sites.

* Supervise contractors during critical installations of process equipment and associated utilities.

* Other duties as assigned by client, based on workload and project requirements.

Qualifications

* Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, Change Controls.

* 10+ years of experience pharma process engineering experience, with at least 5 years of process engineering experience. 

* Excellent written and spoken English is required including the preparation of technical documents in English

* Experience in leading teams.

* Experience with, and knowledge of some of the typical Biotechnology processes & peripheral systems is required; Upstream Biotech Processes (Fermentation, Bioreactors, Centrifugation, Thawing), Downstream / Purification Biotech Processes (chromatography, TFF, DF, NF-MF), Fill & Finish equipment, Media Preparation, CIP/SIP systems, Buffer Preparation, clean utilities (PW, WFI, CS, PS)

* Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.

* Possess mentorship skills, to coach and develop junior and intermediate employees.

* Basic knowledge of AutoCAD is an asset.

* Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.