Manufacturing 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

Description

Manufacturing Process Engineer

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? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this Position:

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.

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.