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Aseptic Process Engineer Jobs in Michigan (NOW HIRING)

fairlife

Aseptic Quality Engineer

Coopersville, MI · On-site

$10K/mo

The Aseptic Quality Engineer will efforts across all manufacturing sites to reduce quality failures ... Work with process authority to support validation activities as part of new line extension and ...

BoehringerPRD

The Senior Principal Engineer, Process will serve as a process-specific Subject Matter Expert (SME) for one or more aspects of the aseptic manufacturing process, including but not limited to Active ...

fairlife

Process Automation Engineer

Coopersville, MI · On-site

The Process Automation Engineer continuously supports plant processing, packaging and utility ... aseptic filling equipment installed in the plants to key stakeholders. * Providing verbal and ...

fairlife

Process Automation Engineer

Coopersville, MI · On-site

The Process Automation Engineer continuously supports plant processing, packaging and utility ... aseptic filling equipment installed in the plants to key stakeholders. * Providing verbal and ...

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Aseptic Process Engineer information

What is an aseptic process engineer?

Aseptic process engineers are professionals who design, develop, and maintain sterile manufacturing systems, primarily in the pharmaceutical, biotechnology, and food industries. Their main responsibility is to ensure that products are produced in a contamination-free environment, using processes that prevent the introduction of microorganisms. This involves overseeing the design of cleanrooms, validating equipment, developing standard operating procedures, and ensuring regulatory compliance. Aseptic process engineers work closely with quality assurance teams to maintain high standards of product safety and efficacy. Their expertise is crucial for industries where product sterility is critical to consumer safety.

What are some common challenges faced by aseptic process engineers, and how can they be addressed?

Aseptic Process Engineers often encounter challenges such as maintaining strict sterility standards, troubleshooting equipment issues, and ensuring compliance with changing regulatory requirements. Addressing these challenges requires strong attention to detail, proactive communication with cross-functional teams, and staying current with industry best practices and regulations. Collaborating closely with quality assurance, production, and maintenance teams helps to identify and resolve issues quickly, ensuring that processes remain efficient and compliant.

What is the difference between Aseptic Process Engineer vs Pharmaceutical Manufacturing Technician?

AspectAseptic Process EngineerPharmaceutical Manufacturing Technician
CredentialsBachelor's degree in engineering, life sciences, or related field; GMP trainingHigh school diploma or associate degree; GMP training often required
Work EnvironmentCleanroom, sterile environments, manufacturing facilitiesManufacturing floors, production areas, sometimes cleanrooms
Industry UsageDesign, optimize, and validate aseptic processes in pharmaOperate equipment, assemble products, support manufacturing

The Aseptic Process Engineer focuses on designing and validating sterile manufacturing processes, requiring specialized engineering knowledge. In contrast, the Pharmaceutical Manufacturing Technician handles day-to-day production tasks, often with less formal education but essential for maintaining manufacturing flow. Both roles are vital in pharmaceutical production but differ in responsibilities and qualifications.

What are the key skills and qualifications needed to thrive as an aseptic process engineer, and why are they important?

Aseptic Process Engineers need a strong background in chemical, mechanical, or biomedical engineering, along with experience in aseptic manufacturing environments and a solid understanding of GMP regulations. Familiarity with process automation systems, sterilization equipment, and industry certifications such as Six Sigma or Lean Manufacturing are often required. Attention to detail, strong problem-solving abilities, and effective communication are vital soft skills for ensuring product quality and process efficiency. These skills are crucial for maintaining sterile conditions, regulatory compliance, and the safe production of pharmaceuticals or biotechnology products.
What are popular job titles related to Aseptic Process Engineer jobs in Michigan? For Aseptic Process Engineer jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Aseptic Process Engineer jobs in Michigan look for? The top searched job categories for Aseptic Process Engineer jobs in Michigan are:
What cities in Michigan are hiring for Aseptic Process Engineer jobs? Cities in Michigan with the most Aseptic Process Engineer job openings:
Aseptic Process Engineer jobs near you
Infographic showing various Aseptic Process Engineer job openings in Michigan as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Manufacturing Process Engineer

Grand River Aseptic Manufacturing

Grand Rapids, MI • On-site

$70K - $94K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 16 days ago

Job 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.
If you meet the required criteria listed above, GRAM welcomes you to apply today!

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