Process Engineer

Yoh is hiring a Process Engineer for our Pharmaceutical Manufacturing client in Noblesville, Indiana.

This position will support a fast-paced sterile drug-product manufacturing operation. The Process Engineer will lead process and equipment improvements, troubleshoot manufacturing issues, establish performance metrics, investigate failures, and support new products and manufacturing lines within a cGMP environment.

• Lead process improvement, equipment reliability, troubleshooting, and remediation initiatives across manufacturing operations.
• Establish and monitor process KPIs related to reliability, quality, throughput, yield, downtime, and operational performance.
• Evaluate, design, and implement robust manufacturing processes for new products using existing or new equipment.
• Support product launches, technology transfers, and implementation of new manufacturing lines.
• Lead formal root-cause investigations involving manufacturing processes and equipment.
• Author deviations, determine root causes, and develop corrective and preventive actions to prevent recurrence.
• Write and execute technical documentation, including engineering protocols, reports, risk assessments, and process-improvement documentation.
• Initiate and support change controls associated with equipment and process improvements.
• Partner with Quality, Manufacturing, Validation, Technical Services, R&D, and other functions to ensure compliant implementation of cGMP practices.
• Provide input into project-cost forecasts and track project activities against established milestones.
• Develop and maintain manufacturing procedures, batch records, equipment documentation, and training materials.
• Provide hands‑on manufacturing‑floor support during equipment issues, process changes, startup activities, and project implementation.

• Bachelor's degree in Engineering required. Mechanical Engineering is preferred;
  Chemical, Biochemical, Biotechnology, Manufacturing, or another engineering discipline may be considered based on relevant experience.
• Five or more years of relevant engineering experience in a cGMP manufacturing environment.
• Demonstrated experience optimizing manufacturing processes and establishing or monitoring process KPIs.
• Hands‑on experience troubleshooting manufacturing processes or equipment and implementing sustainable reliability or quality improvements.
• Experience leading formal root‑cause analysis using structured problem‑solving methodologies.
• Experience authoring deviations, CAPAs, change controls, protocols, technical reports, or comparable controlled documentation.
• Working knowledge of cGMP requirements, validation, quality systems, document control, and the regulatory impact of engineering changes.
• Experience supporting cross‑functional projects from evaluation and design through implementation and operational handoff.
• Strong project‑management, organizational, technical‑writing, and communication skills.
• Ability to work independently while collaborating effectively within multidisciplinary project and manufacturing teams.

• Automated visual inspection systems
• Vial inspection or vial‑labeling equipment
• Pharmaceutical packaging equipment or packaging lines
• Sterile injectable, aseptic, or fill‑finish manufacturing
• New‑product introduction, technology transfer, or manufacturing‑line startup
• Medical‑device or other highly regulated manufacturing environments may also be considered when accompanied by strong process‑engineering, validation, and quality‑system experience

• Must be able to work fully onsite in Noblesville, Indiana, Monday through Friday from 8:00 a.m.
  
  -5:00 p.m.

#IND-SPG

Estimated Min Rate
: $95000.00

Estimated Max Rate
: $110000.00

Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement…