Aseptic GMP Process Engineer - Impact & Innovation

Grand River Aseptic Manufacturing, Inc.; Grand Rapids (MI); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical insurance from day 1

401(k) vesting from day 1

Volunteer time off

Job summary

Grand River Aseptic Manufacturing, Inc. is seeking a Manufacturing Process Engineer to execute technical tasks in a GMP multi-product facility, focusing on aseptic fill/finish operations and formulation/prep.

You will contribute to compliant, high-quality manufacturing processes and support ongoing improvements. The role requires a engineering background with strong data-analysis skills, readiness for off-shift work, and collaboration across QA, MSAT, and senior management to ensure safety,

Qualifications

• Bachelor’s degree in mechanical or electrical engineering, automation, or life sciences or equivalent work experience.
• Proficient in Microsoft Word, Excel and Outlook.
• Available for off-shift and/or on-call work, as needed.
• Experience in GMP manufacturing environments preferred.
• Previous experience in a CMO and/or sterile pharmaceutical manufacturing preferred.

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 aseptic fill/finish technologies.
• Execute minor preventive maintenance and support more advanced PMs.
• Participate in process optimization and troubleshooting for production equipment and software.
• Communicate with leadership on solutions to minimize human error, mechanical failure, and contamination.
• Support process and plant improvements to increase efficiency and manage costs.
• Update SOPs and forms to improve processes.
• Collaborate with manufacturing, QA, facility engineers, MSAT, microbiologists, project managers, and senior management.
• Provide guidance during upgrades of clean rooms and utilities.
• Take corrective action with sound science and engineering analysis.
• Execute assignments to support multi-shift operations, training, and testing.

Skills

Mechanical engineering

Electrical engineering

Automation

cGMP knowledge

Microsoft Word

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 with 2 years

Tools

Microsoft Word

Excel

Outlook

Job description

Grand River Aseptic Manufacturing, Inc. is seeking a Manufacturing Process Engineer to execute technical tasks in a GMP multi-product facility, focusing on aseptic fill/finish operations and formulation/prep.

You will contribute to compliant, high-quality manufacturing processes and support ongoing improvements. The role requires a engineering background with strong data-analysis skills, readiness for off-shift work, and collaboration across QA, MSAT, and senior management to ensure safety,