Job ID: #11803

Introduction
Visium Resources has been asked to identify qualified candidates for this Senior Pharmaceutical Process Engineer position with an emphasis on Purification (Chrom, UFDF, Nanofiltration, TFF). This position is a direct hire opportunity which is expected to be on-site in Kankakee, Illinois.

Summary

Client is seeking an experienced Senior Process Engineer - Purification 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.

Job Description:

* 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 resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing