Business Process Manager

Target PR Range: 40-57/hr
*Depending on experience

The Process Owner will lead key process transformation, design, and improvement efforts across three distinct equipment-related projects at Kankakee site. 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.

Project-Specific Focus Areas
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

Qualifications:

- 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