Senior Pharma / Biotech Process Engineer (Buffers & CIP)

Visium Resources•Kankakee, IL

1d•Onsite

About The Position

Visium Resources has been asked to identify qualified candidates for this Senior Pharmaceutical Process Engineer position with an emphasis on Buffers & CIP. This position is a direct hire opportunity which is expected to be on-site in Kankakee, Illinois. Client is seeking an experienced Senior Process Engineer to support a major pharmaceutical capital expansion project at manufacturing campus in Kankakee, Illinois. Serving as the Owner's Representative, this individual will provide technical leadership throughout the design, procurement, fabrication, installation, commissioning, qualification, and startup of downstream purification systems. The successful candidate will ensure that engineering deliverables prepared by the Architect/Engineer (A/E), equipment manufacturers, and system suppliers meet the Owner's User Requirements Specifications (URS), process performance requirements, GMP standards, and long-term operational objectives. The Senior Process Engineer will work closely with Process Engineering, Automation, Commissioning & Qualification (C&Q), Validation, Manufacturing, Quality, Construction, Procurement, and equipment vendors to successfully deliver complex purification systems supporting plasma-derived therapeutics and biologics manufacturing.

Requirements

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 6 years of bioprocess engineering experience (upstream or downstream).
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.
Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.
Buffer Preparation Systems
Liquid/Liquid Buffer Preparation
Solid/Liquid Buffer Preparation
Inline Dilution Systems
Batch Buffer Make Systems
Duty/Standby Buffer Supply Systems
Buffer Storage and Distribution Systems
CIP Systems
Centralized Clean-in-Place (CIP) Systems
Dedicated CIP Skids
CIP Distribution Networks
Automated Cleaning Sequences
CIP Recipe Development
Sanitary Process Piping

Nice To Haves

Basic knowledge of AutoCAD is an asset.

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: Feasibility, Concept Design, Basic Design, Detailed Design, Procurement, Construction, Project Monitoring/Governance, 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 MMR Consulting. 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 MMR 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, and/or MMR, based on workload and project requirements.