What are the responsibilities and job description for the Process Manager (Lifts, Columns, Bulk Chemical Delivery) position at IntePros?
Our client is seeking a Process Owner to lead key process transformation, design, and improvement initiatives across multiple equipment-related projects at their Kankakee site. This role will work closely with Manufacturing, Quality, and Facilities & Engineering to ensure that systems are designed and implemented to meet internal customer needs, business objectives, and patient safety requirements.
The Process Owner will serve as a subject matter expert (SME), providing leadership in process design, documentation ownership, compliance oversight, and coaching throughout each project’s lifecycle.
Primary Project Areas
Assignments will depend on the candidate’s expertise and project priorities:
Lift Systems
User Requirements & System Design
The Process Owner will serve as a subject matter expert (SME), providing leadership in process design, documentation ownership, compliance oversight, and coaching throughout each project’s lifecycle.
Primary Project Areas
Assignments will depend on the candidate’s expertise and project priorities:
Lift Systems
- Hands-on experience with mechanical lifting equipment in a biopharmaceutical or GMP-regulated environment
- Strong focus on ergonomics, safety, and compliance
- Knowledge of column design, qualification protocols, and integration into purification processes
- Experience with bulk chemical handling, piping, and delivery systems
- Familiarity with acids, bases, and cleaning/passivation agents
User Requirements & System Design
- Collaborate with cross-functional teams to define and document User Requirements Specifications (URS)
- Ensure design solutions align with operational, safety, and regulatory requirements
- Participate in design reviews, including P&ID, HAZOP, and FMEA sessions
- Provide input on system usability, safety, and accessibility
- Support FAT, SAT, and CQV (IV, OV, IOQ, PQ) testing activities
- Identify and escalate functional gaps, deviations, or nonconformances
- Contribute to the development of SOPs and Work Instructions
- Support hands-on training and knowledge transfer to end users
- Evaluate system performance and collaborate on improvement initiatives
- Ensure all documentation meets GMP/GDP requirements
- Support audit preparation and inspection readiness activities
- Qualifications
- Bachelor’s degree in Mechanical, Chemical, or Manufacturing Engineering (or related field)
- 4 years of relevant experience with a BS; 2 years with an MS
- Prior experience in pharmaceutical or biopharmaceutical manufacturing strongly preferred
- Solid understanding of GMP, FDA, and other regulatory standards
- Proficiency in Microsoft Office and strong technical writing skills
- Excellent interpersonal, problem-solving, and collaboration abilities