Aseptic GMP Process Engineer

Grand River Aseptic Manufacturing; Grand Rapids (MI); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Benefits starting day 1

Paid volunteerism starting day 1

PTO & wellness time off

Job summary

Grand River Aseptic Manufacturing seeks a Manufacturing Process Engineer to drive GMP operations in a multi-product aseptic filling and formulation environment.

You will execute change controls, assess cGMP discrepancies, analyze batch data, and support equipment with hands-on maintenance and process optimization. The role requires a bachelor’s in engineering, 2+ years of relevant pharma experience, and willingness for off-shift/on-call work; on-site at GRAM's facility in Michigan.

Qualifications

• Bachelor's degree in mechanical or electrical engineering, automation, or life sciences OR equivalent work experience.
• Master's degree with 1 year of relevant experience or Bachelor's degree with 2 years of relevant experience or 7 years of relevant training and/or experience.
• Proficient computer skills in Microsoft Word, Excel and Outlook.
• Available for off-shift and/or on-call work, as needed.

Responsibilities

• Execute actions from Change Control and CA/PA projects for the manufacturing/finishing department.
• Assess, evaluate, and provide corrective actions for cGMP discrepancies.
• Assist with batch process data, analyze data set, and generate applicable report.
• Develop expertise to ensure equipment in functional area is maintained and operational. Work hands on with advanced aseptic fill/finish technologies with some flexibility for on-site support during critical operations.
• Execute minor preventative maintenance (PM) activities. Provide support for more advanced PMs executed by the maintenance department and outside vendors.
• Participate in process optimization and troubleshooting efforts for production equipment and software.
• Communicate with leadership on solutions that minimize human error, mechanical failure, environmental contamination, and procedural deviation.
• Support process and plant improvements to increase efficiency and manage costs.
• Update SOPs and forms to improve processes.
• Effectively collaborate with manufacturing, quality assurance, facility engineers, MSAT, microbiologists, project managers, and senior management team.
• Provide guidance to facility engineering and validation during upgrades of clean room spaces and utilities.
• Take corrective action by thinking creatively, solving problems, and develop innovative solutions based on sound science and engineering analysis.
• Execute assignments as directed to support multi-shift operations, training, and testing.

Skills

Microsoft Word

Microsoft Excel

Outlook

Education

Bachelor's degree in mechanical or electrical engineering, automation, or life sciences

Master's degree with 1 year of relevant experience or Bachelor's degree with 2 years of relevant experience

Job description

Grand River Aseptic Manufacturing seeks a Manufacturing Process Engineer to drive GMP operations in a multi-product aseptic filling and formulation environment.

You will execute change controls, assess cGMP discrepancies, analyze batch data, and support equipment with hands-on maintenance and process optimization. The role requires a bachelor’s in engineering, 2+ years of relevant pharma experience, and willingness for off-shift/on-call work; on-site at GRAM's facility in Michigan.