Pharma Process Engineer: cGMP, Process Improvement & Reliability

Yoh,-A-Day-; Noblesville (IN); On-site; USD 95,000 - 110,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision benefits

HSA

Life Insurance

Disability Insurance

401K

Direct Deposit

Referral bonuses

Training opportunities

Job summary

Yoh is seeking a Process Engineer for a pharmaceutical manufacturing client in Noblesville, Indiana. The role supports a fast-paced sterile drug-product operation and leads process and equipment improvements in a cGMP environment.

Responsibilities include establishing KPIs, troubleshooting, root-cause investigations, change controls, and working cross-functionally with Quality, Manufacturing, Validation, and R&D to ensure compliant implementation and successful product launches.

Qualifications

• Five or more years of relevant engineering experience in a cGMP manufacturing environment.
• 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.

Responsibilities

• 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.

Skills

Project management

Organizational skills

Technical writing

Communication

Education

Bachelor's degree in Engineering

Job description

Yoh is seeking a Process Engineer for a pharmaceutical manufacturing client in Noblesville, Indiana. The role supports a fast-paced sterile drug-product operation and leads process and equipment improvements in a cGMP environment.

Responsibilities include establishing KPIs, troubleshooting, root-cause investigations, change controls, and working cross-functionally with Quality, Manufacturing, Validation, and R&D to ensure compliant implementation and successful product launches.