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Aseptic Process Engineer Jobs in Michigan (NOW HIRING)

BoehringerPRD

The Senior Principal Engineer, Automation will serve as an Automation Process-specific Subject Matter Expert (SME) for one or more aspects of the aseptic manufacturing process System Integration ...

Actalent

Quality Control Manager

Grand Rapids, MI

$100K - $140K/yr

... in-process microbiology testing in support of aseptic manufacturing. This role ensures the ... About Actalent Actalent is a global leader in engineering and sciences services and talent ...

New

NSF

Scientist I - Microbiology

Traverse City, MI · On-site

... aseptic discipline and timing precision that microbiological testing demands. We are looking for someone technically capable and detail-oriented - a careful, process-disciplined bench scientist who ...

NSF

Scientist I - Microbiology

Traverse City, MI · On-site

... aseptic discipline and timing precision that microbiological testing demands. We are looking for someone technically capable and detail-oriented - a careful, process-disciplined bench scientist who ...

Nestlé S.A.

Principal Thermal Processing

Fremont, MI · On-site

$150 - $190/hr

... process design, validation strategies (aseptic, retort, hot‑fill), and decision logic * Serve as ... Bachelor's degree in Engineering, Food Science, or related field (advanced degree preferred) * 10+ ...

Nestle

Principal Thermal Processing

Fremont, MI · On-site

... process design, validation strategies (aseptic, retort, hot-fill), and decision logic * Serve as ... Bachelor's degree in Engineering, Food Science, or related field (advanced degree preferred) * 10+ ...

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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 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 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 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.

Manager, Maintenance Engineering & Reliability

Endo International

Rochester, MI • On-site

Full-time

Posted 25 days ago

Key responsibilities

  • Provides strategic leadership for maintenance engineering, reliability, utility systems, and technical support functions to achieve safety, quality, delivery, compliance, and cost objectives.

  • Establishes organizational capability, staffing, and resource strategies to support current and future business requirements.

  • Leads equipment and system investigations, identifies root causes, and drives corrective and preventive actions to improve reliability, compliance, and operational performance.

Job description

Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Job Description Summary
The Manager, Maintenance Engineering & Reliability provides leadership for maintenance engineering, reliability programs, utility systems, technical compliance activities, and maintenance resources supporting manufacturing operations. Working closely with Manufacturing, Engineering, Quality, Safety, and Technical Operations teams, this position is responsible for ensuring the reliability, compliance, safety, and performance of facility, utility, and manufacturing support systems through effective leadership, resource management, continuous improvement, and operational excellence.
Job Description
Leadership Accountabilities:
Budget Responsibility
  • Responsible for development, management, and performance of the Maintenance Engineering operating budget.
  • Provides input and support for capital planning and capital project expenditures.

Span of Control
  • Maintenance Trades, Systems Administrator(s), or other assigned personnel.
  • Indirect Reports: Contractors, service providers, and cross-functional project teams.

Essential Duties and Responsibilities:
  • Provides strategic leadership for maintenance engineering, reliability, utility systems, and technical support functions to achieve safety, quality, delivery, compliance, and cost objectives.
  • Establishes organizational capability, staffing, and resource strategies to support current and future business requirements.
  • Develops and implements maintenance systems, processes, and strategies that improve equipment reliability, maintenance effectiveness, and overall business performance.
  • Ensures maintenance activities, facility systems, utilities, and equipment comply with cGMP, OSHA, corporate, and regulatory requirements.
  • Provides strategic oversight of critical utility systems, including WFI, Clean Steam, Compressed Air, Nitrogen, HVAC, HEPA and supporting facility infrastructure.
  • Provides oversight of Advanced Aseptic Manufacturing systems, including Vaporized Hydrogen Peroxide Decontamination Isolators, Depyrogenation Systems, Sterilization Systems, Aseptic Vial Filling and capping.
  • Provides oversight of Automated Parenteral Inspection and Packaging systems, including Automated particulate and cosmetic inspection, Serialization, Cartoning and Case Packing.
  • Establishes maintenance priorities, resource allocation plans, escalation processes, and response strategies to support safe, reliable, and compliant operations.
  • Leads equipment and system investigations, identifies root causes, and drives corrective and preventive actions to improve reliability, compliance, and operational performance.
  • Provides maintenance engineering leadership for capital projects, equipment installations, new product introductions, FATs, process improvements, and PMO initiatives.
  • Collaborates with Manufacturing, Technical Operations, Engineering, Quality, Safety, and other cross-functional teams to improve process performance, equipment reliability, and operational effectiveness.
  • Ensures inspection readiness and quality system effectiveness by overseeing procedures, investigations, change controls, maintenance practices, regulatory inspections, customer audits, and remediation activities.
  • Leads employee development, succession planning, training effectiveness, performance management, and leadership development initiatives while fostering a culture of accountability, collaboration, Right First Time (RFT), and Continuous Improvement (CI).
  • Develops and manages maintenance engineering budgets, forecasts resource requirements, and supports long-range planning activities.
  • Communicates maintenance performance metrics, project status, operational risks, and improvement opportunities to support informed decision-making and achievement of business objectives.

Core Competencies:
Maintenance Engineering & Reliability Expertise:
  • Demonstrates advanced knowledge of maintenance engineering, reliability programs, utility systems, facility infrastructure, equipment lifecycle management, maintenance strategies, and regulatory compliance requirements. Applies technical expertise to improve equipment performance, reliability, and operational effectiveness.

Leadership & Talent Development:
  • Provides strong leadership through coaching, mentoring, performance management, workforce development, and succession planning. Builds engaged, capable teams that support current and future business needs.

Strategic Thinking & Business Acumen:
  • Aligns maintenance engineering strategies with organizational goals. Effectively balances safety, quality, compliance, delivery, cost, and resource utilization to support business performance.

Compliance & Quality Focus:
  • Maintains a strong commitment to cGMP, OSHA, regulatory, and corporate requirements. Ensures inspection readiness and supports robust quality system performance.

Communication & Influence:
  • Communicate effectively with all organizational levels through presentations, reports, meetings, and technical discussions. Use data and expertise to influence decisions and drive results.

Cross-Functional Collaboration:
  • Build strong partnerships with Manufacturing, Engineering, Quality, Safety, Technical Operations, and project teams to achieve common goals and improve organizational effectiveness.

Continuous Improvement & Operational Excellence:
  • Driving a culture of continuous improvement through data analysis, root cause problem solving, reliability initiatives, process optimization, and implementation of best practices.

Required Qualifications:
To be considered for this role, you must have experience in:
  • Maintenance Reliability Strategy
  • Aseptic Manufacturing Equipment Oversight
  • Maintenance Systems and Process Improvement
  • Utility Systems Leadership
  • Automated Inspection and Packaging Systems
  • Maintenance Engineering and Reliability
  • Equipment Lifecycle Management
  • Regulatory Compliance in Maintenance Operations
  • Performance Metrics and Executive Communication
  • Computerized Maintenance Management Systems (CMMS)

Education and Experience:
  • Bachelor's degree in engineering, Engineering Technology, Facilities Management, Industrial Technology, Reliability Engineering, or a related technical discipline preferred.
  • Master's degree preferred.
  • Minimum 7-10 years of progressive experience in a regulated manufacturing environment.
  • Minimum 5 years of leadership experience.
  • Pharmaceutical manufacturing experience strongly preferred.
  • Experience supporting utility systems, facility infrastructure, equipment reliability, maintenance strategy, and regulatory compliance programs preferred.

Physical Demands / Work Environment:
Work is performed in both office and manufacturing environments and requires regular use of computers and maintenance systems. Frequent walking throughout the facility is required to inspect equipment, support maintenance activities, oversee projects, and monitor utility operations. The position requires occasional climbing, bending, kneeling, reaching, and lifting to 35 pounds. Must be able to wear required PPE and work safely around manufacturing and utility equipment. Occasional support of off-shift activities, audits, outages, emergency response, and project implementations may be required.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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