Manufacturing Process Engineer

Grand River Aseptic Manufacturing - Grand Rapids, MI

Full-time - Mid Level

Grand Rapids, MI

Chemical Manufacturing

About the position

The Manufacturing Process Engineer at Grand River Aseptic Manufacturing (GRAM) is responsible for executing technical support activities for GMP Manufacturing Operations in a multi-product Fill/Finish CMO facility. This role focuses on compliance, quality, innovation, and plant performance, specifically in either Aseptic Filling or Formulation/Prep. The engineer will work closely with production teams to ensure efficient operations and maintain high standards of quality and safety.

Responsibilities

• Transfer technical processes from the MSAT and validation groups to the production floor with the assistance of the Production Team.
• Assess, evaluate, and provide immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis, and reporting.
• Develop technical expertise to ensure equipment in functional area is maintained and operational by completing or assisting with preventative maintenance activities.
• Oversee and train on the changeover and testing of equipment between different product configurations for high-speed filling lines in an isolator environment.
• Oversee and execute formulation activities including setup, thaw, weigh/dispense, compounding, dilution, and all other activities upstream of the sterile filter.
• Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error.
• Support strategic plans for process and plant improvements to increase efficiency and manage costs.
• Work with Tech Transfer and Project Management teams to transition products through the product development timeline.
• Implement and review operational documentation systems within Manufacturing, Operations and Process Development.
• Collaborate effectively with team members, production operators, engineers, microbiologists, analytical chemists, project managers, and senior management.
• Assist engineering and validation with implementation, commissioning, and validation of clean room spaces and process equipment.
• Initiate revisions to cGMP procedures and master batch records as applicable.

Requirements

• Bachelor's degree in mechanical or electrical engineering, automation, or life sciences, or equivalent training and/or experience.
• Three years in a production engineering role, or 3-5 years of relevant experience in pharmaceutical manufacturing or a laboratory environment.
• Availability for off-shift and/or on-call work as needed.

Nice-to-haves

• Previous experience in a CMO and/or sterile pharmaceutical manufacturing.

Benefits

• Medical benefits starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits with the company paying for 75% of the cost.
• Paid volunteerism starting day 1: 16 hours of paid volunteer time per calendar year.
• PTO: Up to 17 days of time off per calendar year for vacation, sick, or mental health needs.
• Wellness Time Off: One paid day of Wellness Time Off (WTO) per quarter.
• Paid holidays: 10 paid holidays per calendar year with immediate eligibility.