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

$95000.00

$110000.00

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

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