Process Engineer

Noblesville, Indiana Manufacturing 28 days ago

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Leads process optimization, equipment reliability, validation, and continuous improvement activities within a regulated cGMP manufacturing environment.

Job Requirements

  • Bachelor’s degree in Engineering; Mechanical Engineering preferred.
  • 5+ years of experience in cGMP manufacturing.
  • Experience with process optimization and manufacturing process improvement.
  • Experience with process validation.
  • Experience working within regulated quality systems.
  • Experience performing root cause analysis and technical investigations.
  • Experience in pharmaceutical, biologics, medical device, food processing, or another regulated manufacturing industry.
  • Experience developing change controls and CAPAs.
  • Ability to travel up to 10%.

Preferred Skills

  • Experience with automated visual inspection systems.
  • Experience with vial labeling processes.
  • Experience with pharmaceutical packaging operations.
  • Lean certification.
  • Six Sigma certification.
  • Experience supporting new product introductions and manufacturing line implementation.

Job Responsibilities

  • Lead process improvement and equipment reliability initiatives.
  • Troubleshoot manufacturing process and equipment issues.
  • Develop and implement process enhancements.
  • Create and execute change controls and corrective and preventive actions.
  • Support new product introductions and manufacturing line implementations.
  • Conduct root cause investigations for process, equipment, and quality issues.
  • Develop technical documentation, protocols, and engineering reports.
  • Support process validation activities.
  • Monitor and maintain manufacturing process KPIs.
  • Review and update batch records and operating procedures.
  • Develop and maintain technical training materials.
  • Support equipment maintenance and reliability activities.
  • Ensure engineering activities comply with applicable cGMP and quality system requirements.


Pay Details: $105,000.00 to $110,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance


Massachusetts Candidates Only: 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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Equal Opportunity Employer/Veterans/Disabled
The Company will consider qualified applicants with arrest and conviction records.

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