Senior Process Engineer; Buffers & CIP

Relocation & Expenses can be negotiated.

Customer Note - Role is mostly full time onsite, they could likely go and work from home for one week every month or two (at the discretion of their manager and depending on what’s going on with the project at that time).

The term process engineer gets misused very often and can be used for process equipment design, or process development or validation - this role needs to be someone who knows process Equipment design very well, not process development or validation or scaleup.

We are 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 & 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 Owners 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.

• 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 project stages such as
  • Feasibility
  • Concept Design, Basic Design, Detailed Design
  • Procurement
  • Construction
  • Project Monitoring/Governance
• Prepare, perform, and review process engineering drawings, calculations, PFDs, P&IDs and other engineering documentation.
• Prepare and review technical specifications and datasheets for equipment, instrumentation, and systems.
• 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 and review User Requirements Specifications (URS).
• Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), and support execution of Commissioning & Qualification.
• Prepare and review automation sequences, such as Functional Specifications, Valve & Alarm Matrices.
• Coordinate with other engineering disciplines and cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).
• Facilitate project management tools throughout the execution of projects, including procurement tracking, vendor management, meeting minutes/action lists, risk register log, schedule updates, and project updates.
• Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates.
• Travel may sometimes be required for meetings with the client and equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support during 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 company resources for effective project delivery, supporting business development (providing…