Job Title: Process Engineer
Location: Greater Kansas City Area, Kansas
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Job Summary:We are seeking a Process Engineer with 3โ7 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments. The role will support manufacturing operations for a monoclonal antibody (mAb) production facility, focusing on process optimization, equipment troubleshooting, commissioning, qualification, validation, and continuous improvement activities.
Key Responsibilities
- Provide technical support for manufacturing processes and equipment.
- Troubleshoot process and equipment-related issues on the production floor.
- Support commissioning, qualification, and validation of manufacturing equipment and systems.
- Assist with capital projects, including equipment design, installation, and startup activities.
- Monitor process performance and implement process improvements.
- Perform root cause investigations and support CAPA, Change Control, and Deviation activities.
- Ensure compliance with cGMP, quality standards, and regulatory requirements.
- Create and maintain engineering documents such as P&IDs, PFDs, URS, and qualification protocols.
- Support SIP (Steam-In-Place) and CIP (Clean-In-Place) systems.
- Collaborate with Manufacturing, Quality, Validation, and Engineering teams.
Required Skills:
- Process Engineering
- Process Troubleshooting
- Commissioning, Qualification & Validation (CQV)
- SIP/CIP Systems
- P&IDs and PFDs
- GMP / cGMP Compliance
- Root Cause Analysis (RCA)
- CAPA, Change Control, and Deviation Management
- Data Analysis and Continuous Improvement
Required Qualifications:
- Bachelorโs Degree in Engineering, Biotechnology, Chemical Engineering, Mechanical Engineering, or related Science discipline.
- 3โ7+ years of experience in Pharmaceutical, Biotechnology, Medical Device, or other regulated industries.
- Experience working in a cGMP-regulated manufacturing environment.
Strong problem-solving, communication, and teamwork skills.