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.

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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

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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.