This is a hands-on manufacturing-floor engineering role supporting automated equipment and processes within a fast-paced cGMP sterile drug-product operation. The Process Engineer will own manufacturing-equipment troubleshooting, recurring-failure elimination, reliability and process improvements, performance monitoring, and implementation of new equipment, products, and manufacturing processes.
This position is best suited for an engineer who has personally supported production equipment, diagnosed equipment or process failures, implemented engineering changes, and demonstrated measurable improvements in reliability, quality, throughput, yield, or downtime. This is not a validation-only, quality-assurance, documentation, or continuous-improvement-only position.
What You Will Do
- Provide hands-on engineering support for automated manufacturing equipment and production processes.
- Troubleshoot recurring equipment and process failures, determine root causes, and implement sustainable corrective engineering solutions.
- Lead equipment-reliability and process-improvement initiatives that improve uptime, throughput, yield, quality, scrap, cycle time, or other manufacturing KPIs.
- Establish, monitor, and trend process and equipment performance metrics to identify reliability and performance opportunities.
- Evaluate, design, modify, and implement manufacturing processes and equipment for existing and new products.
- Support installation, commissioning, startup, qualification, and operational handoff of new or modified manufacturing equipment.
- Support new-product introductions, technology transfers, and manufacturing-line implementation.
- Lead structured root-cause investigations involving manufacturing processes and equipment.
- Author and support deviations, CAPAs, change controls, risk assessments, engineering protocols, technical reports, and other controlled documentation associated with equipment and process changes.
- Partner with Manufacturing, Quality, Validation, Maintenance, Automation, Technical Services, R&D, and other functions to implement compliant engineering improvements.
- Support troubleshooting and diagnostic activities involving automated equipment, PLC/HMI-controlled systems, sensors, machine controls, and associated mechanical systems.
- Develop and maintain manufacturing procedures, equipment documentation, batch-record content, and training materials.
- Provide hands-on manufacturing-floor support during equipment failures, process changes, startup activities, and project implementation.
- Support project schedules, cost forecasts, and implementation milestones.
- Bachelor’s degree in Mechanical, Chemical, Manufacturing, Biochemical, Biotechnology, or another relevant Engineering discipline strongly preferred. Candidates with a closely related technical degree and substantial directly relevant manufacturing-equipment engineering experience may also be considered.
- Approximately 5+ years of relevant engineering experience supporting manufacturing equipment and processes.
- Experience in pharmaceutical, biopharmaceutical, medical-device, or another highly regulated manufacturing environment strongly preferred.
- Demonstrated hands-on ownership of manufacturing equipment or processes, including troubleshooting equipment failures and implementing engineering improvements.
- Ability to provide examples of identifying a manufacturing or equipment problem, determining root cause, implementing a corrective engineering change, and measuring the resulting improvement.
- Experience improving equipment reliability, downtime, throughput, yield, reject rate, scrap, cycle time, OEE, or comparable manufacturing-performance metrics.
- Experience with structured root-cause analysis and technical problem-solving.
- Experience supporting equipment installation, commissioning, startup, qualification, or manufacturing-line implementation.
- Working knowledge of cGMP requirements, validation, quality systems, document control, and the regulatory impact of equipment and process changes.
- Experience with deviations, CAPAs, change controls, engineering protocols, technical reports, risk assessments, or comparable controlled documentation.
- Strong project-management, organizational, technical-writing, and cross-functional communication skills.
Experience with one or more of the following is highly desirable:
- Automated visual inspection or machine-vision systems
- Vial inspection equipment
- Filling or fill-finish equipment
- Vial labeling equipment
- Pharmaceutical packaging or secondary-packaging lines
- Cartoners, case packers, conveyors, or automated material-handling equipment
- Serialization equipment
- Robotics or automated assembly systems
- Integrated automated manufacturing lines
- PLC/HMI-controlled production equipment
- Sensors, controls, or automation-related equipment troubleshooting
- Sterile injectable or aseptic pharmaceutical manufacturing
- Fill-finish manufacturing
- Pharmaceutical packaging
- Radiopharmaceutical manufacturing
- Medical-device manufacturing with strong automated-equipment, validation, and quality-system experience
- New-product introduction, technology transfer, or manufacturing-line startup
- Must be able to work fully onsite in Noblesville, Indiana, Monday through Friday, approximately 8:00 a.m.–5:00 p.m.
- Candidates requiring relocation must be willing to relocate to the Noblesville area at their own expense.
- Applicants must be currently authorized to work in the United States and must not require employer sponsorship for employment visa status now or in the future.
#IND-SPG
Estimated Min Rate:$95,000
Estimated Max Rate:$110,000
What’s In It for You?
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. 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)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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