Manufacturing Process Engineer (Weekends)

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); On-site; USD 70,000 - 95,000; Full time

Job summary

Grand River Aseptic Manufacturing is seeking a Manufacturing Process Engineer to support weekend operations in our GMP aseptic filling environment in Grand Rapids, MI. The role emphasizes adherence to safety, quality, and process excellence in a high-paced facility.

You will execute change controls, analyze batch data, and assist with process optimization. The position requires a strong engineering background and ability to work flexible weekend schedules with on-site support as needed.

Qualifications

• Bachelor's degree in mechanical or electrical engineering, automation, or life sciences or equivalent work experience.
• Master's or Bachelor's with relevant experience as described in the job listing.
• Proficient computer skills in Microsoft Word, Excel and Outlook.

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 with on-site support during critical operations.
• Execute minor preventative maintenance and support for more advanced PMs.
• Participate in process optimization and troubleshooting for production equipment and software.
• Communicate with leadership on solutions that minimize human error 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.

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 or 7 years of relevant training/experience

Tools

Microsoft Word

Excel

Outlook

Job description

Description

Manufacturing Process Engineer (Weekends)

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do?

The Manufacturing Process Engineer executes technical tasks for GMP Manufacturing Operations in a multi-product, Formulation/Fill CMO facility including activities related to compliance, quality, targeted innovation, and plant performance and success. The MPE Contributes to solution strategies for new technical problems encountered during Aseptic Filling and Formulation/Prep.

This position will support production activities on Saturday and Sunday. While ideal workdays are Friday, Saturday, Sunday, and Monday, flexibility exists surrounding workdays as long as weekend coverage is maintained.

Non-Negotiable Requirements:

• Bachelor's degree in mechanical or electrical engineering, automation, or life sciences OR equivalent work experience.
• Prior education and/or relevant engineering 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.

Preferred Requirements:

• 3 years in a production engineering role, or 3 - 5 years of relevant experience in pharmaceutical manufacturing or a laboratory environment.
• Previous experience in a CMO and/or sterile pharmaceutical manufacturing.

Responsibilities Include (but are not limited to):

• 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.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness time off for every 30 hours worked, to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.