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Business Process Manager (3 roles with different focus areas) (M/F/D)
Tasks:
The Process Owner will lead key process transformation, design, and improvement efforts across three distinct equipment-related projects. This role requires close collaboration with Manufacturing, Quality, and Facilities & Engineering to ensure systems meet internal customer, business, and patient needs. The incumbent will serve as a subject matter expert (SME) and provide coaching, documentation ownership, and compliance support throughout the lifecycle of each project.
Candidates may be assigned to one or more of the following projects based on expertise:
- Lift Systems (Immediate Need)
- Experience with mechanical lifting equipment in biopharma environments
- Emphasis on ergonomics, safety, and GMP compliance
- Acrylic Columns (Starts January)
- Familiarity with column design and qualification protocols
- Integration into purification processes
- Bulk Chemical Delivery Systems (Major Project)
- Knowledge of bulk chemical handling, piping, and delivery systems
- Experience with acids, bases, and cleaning/passivation agents
In addition to core Process Owner duties, candidates should demonstrate:
- URS Development
- Collaborate with design teams to define user requirements
Align system functionality with operational, safety, and compliance needs
- Design Review & Risk Assessment
- Participate in P&ID reviews, HAZOP, FMEA
- Provide feedback on usability and accessibility
- Equipment & System Testing Support
- Support FAT, SAT, and CQV activities (IV, OV, IOQ, PQ)
- Report functional gaps or deviations
- Training & Operational Readiness
- Contribute to SOP and Work Instruction development
- Support hands-on training and knowledge transfer
- System Performance Monitoring & Continuous Improvement
- Identify performance deviations and collaborate on improvements
- Compliance & Documentation Review
- Ensure GMP/GDP compliance in documentation
- Support audit and inspection readiness
Qualification:
- Bachelor’s in Mechanical, Chemical, or Manufacturing Engineering (or equivalent)
- 4+ years of relevant experience with BS; 2+ years with MS
- Prior experience in pharmaceutical manufacturing preferred
- Strong knowledge of GMP, FDA, and regulatory standards
- Proficiency in Microsoft Office and technical writing
- Strong interpersonal and collaboration skills
Requirements:
Start: depending on focus area (one asap, one in January, one tbd)
Duration: 6 months
Capacity: 20hrs/ week, full-time might be considered as well
Location: Illinois
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