Manufacturing Science Associate

GOEBEL FIXTURE COMPANY

Saint Cloud (MN)

On-site

USD 56,000 - 70,000

Full time

17 hours ago
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Benefits offered by this job

Medical & dental
HSA
Life insurance
Disability coverage
401(k) match
Tuition reimbursement
Bonus potential
Growth culture

Job summary

Microbiologics, a global biotechnology company, seeks a Manufacturing Science Associate to support product development transfer into scalable manufacturing. The role emphasizes design controls, technology transfer, process validation, and manufacturing readiness to ensure successful transfer of products into routine operations.

Ideal candidates have a Bachelor’s degree in a relevant field and 2–3 years in regulated environments, with strong technical writing and documentation skills.

Qualifications

  • Bachelor’s degree in engineering, life sciences, biology, microbiology, molecular biology, or a related field.
  • Minimum 2–3 years of experience in regulated product development, manufacturing, quality, or engineering.
  • Experience with design controls in a regulated product development environment.
  • Experience supporting technology transfer or transfer of products/processes into manufacturing.
  • Strong technical writing skills with experience drafting procedures and technical reports preferred.
  • Experience with process validation, manufacturing readiness, risk assessment, or transfer in a regulated manufacturing environment preferred.
  • Laboratory or hands-on manufacturing experience preferred.

Responsibilities

  • Support design control activities for new product development and transfer, reviewing design requirements and transfer documentation.
  • Plan and support transfer of new/revised product designs into manufacturing and assess manufacturing readiness.
  • Participate in cross-functional design and transfer readiness reviews to assess manufacturability and risks.
  • Develop, review, and maintain manufacturing documentation, including work instructions and transfer docs for operational readiness.
  • Plan, execute, and document process validations and transfer activities per quality and regulatory requirements.
  • Evaluate manufacturing processes using data and risk-based approaches to identify process risks and controls.
  • Ensure traceability and completeness of technical transfer deliverables for project milestones.

Skills

Technical writing
Design controls
Technology transfer
Process validation
Risk assessment
Lab/manufacturing experience
Documentation drafting

Education

Bachelor’s degree in engineering or life sciences

Job description

  • Location 200 Cooper Avenue North,Saint Cloud, MN, 56303,United States
  • Base Pay $56,000.00 - $70,000.00 / Year
  • Employee Type Full Time - Regular
  • Required Degree 4 Year Degree
  • Manage Others No

Manufacturing Science Associate

At Microbiologics, our impact goes far beyond the lab. As a global biotechnology company with a strong reputation for quality, collaboration, and scientific rigor, we support the health and safety of people around the world through trusted biological products and services.

Everything we do is grounded in our core values: We Win Together, Driven to Achieve, Brave, Bold and Confident, and We Care, which guide how we work, make decisions, and support one another.

We are seeking a Manufacturing Science Associate to support the development and transfer of new products from product design into controlled, scalable, and repeatable manufacturing processes. This role applies knowledge of design controls, technology transfer, process validation, and manufacturing readiness to ensure that product designs can be effectively manufactured and transferred into routine operations.

To Be Considered for This Position, Candidates Must Have the Following Qualifications:
  • Education: Bachelor’s degree in engineering, life sciences, biology, microbiology, molecular biology, or a related field
  • Experience: Minimum of 2–3 years of experience working in a regulated product development, manufacturing, quality, or engineering environment
  • Previous experience with design controls in a regulated product development environment
  • Previous experience supporting technology transfer, design transfer, or the transfer of products/processes into manufacturing
  • Experience developing, reviewing, or maintaining controlled technical documentation
    Strong technical writing skills with experience drafting procedures and technical reports preferred
  • Experience with process validation, manufacturing readiness, risk assessment, or process development and technology transfer in a regulated manufacturing environment preferred
  • Laboratory or hands-on manufacturing experience preferred
Why You’ll Love This Role
  • Support the transfer of new and revised products into manufacturing
  • Contribute to design control, technology transfer, process validation, and manufacturing readiness activities
  • Use data and risk-based approaches to help identify process risks and support manufacturing decisions
  • Collaborate across functional teams to align objectives, timelines, and project execution
  • Apply scientific knowledge and best practices to technical challenges and continuous improvement

You’ll have the opportunity to make a meaningful impact while working in an environment where our values show up in everyday decisions whether that’s collaborating to win together, pushing to achieve more, stepping forward with bold ideas, or showing care for our colleagues and customers.

What You’ll Do
  • Support design control activities associated with new product development and transfer, including review of design requirements, manufacturing considerations, design outputs, and transfer documentation
  • Plan and support the transfer of new and revised product designs into manufacturing, including transfer planning, identification of requirements, coordination of activities, and assessment of manufacturing readiness
  • Participate in cross-functional design and transfer readiness reviews to assess manufacturability, identify gaps and risks, and support manufacturing implementation decisions
Manufacturing Readiness & Validation
  • Develop, review, and maintain manufacturing documentation, including work instructions, training materials, transfer documentation, and other technical documents needed for operational readiness
  • Plan, execute, and document process validations and transfer activities in accordance with applicable quality and regulatory requirements
  • Evaluate manufacturing processes and product requirements using data and risk-based approaches to identify process risks, establish appropriate controls, and support successful transfer
  • Ensure traceability and completeness of technical transfer deliverables and support timely completion of activities required for project milestones and manufacturing readiness
Testing & Technical Support
  • Perform laboratory or manufacturing activities supporting technology transfer, process development, training, and validation activities
  • Provide production and technical support for new, transferred, or customer-specific products requiring specialized capabilities
Data & Cross-Functional Collaboration
  • Compile, analyze, and communicate data to provide insights and recommendations supporting design, transfer, validation, and manufacturing readiness decisions
  • Collaborate with cross-functional teams to align objectives, timelines, and successful project execution
  • Maintain compliance with applicable regulations, company policies, and industry standards
Who Thrives Here
  • Demonstrates strong technical writing and documentation skills
  • Can manage multiple priorities while maintaining strong organization and time management
  • Uses good judgment and sound decision-making skills
  • Brings strong independent and critical thinking skills to their work
  • Is resourceful, self-motivated, and approaches problems with attention to detail
  • Communicates effectively and works collaboratively in a team environment
  • Aligns with our values by working collaboratively, striving for excellence, bringing forward ideas with confidence, and demonstrating care for others
Additional Requirements
  • Ability to pass a background check and drug screening
  • Ability to work in a laboratory environment and follow required safety practices and PPE requirements
  • Ability to occasionally lift and move up to 25 pounds to shoulder height unaccompanied
  • Ability to work directly with Risk Group I and Risk Group II bacteria, yeast, and fungi
  • Ability to pass a color blindness test
Who We Are

Microbiologics is a global biotechnology company and trusted partner to healthcare and life science organizations worldwide. For more than 50 years, we have supported laboratories, manufacturers, and suppliers with high-quality biological control materials, assay services, and consulting.

Headquartered in St. Cloud, Minnesota, with additional facilities across the United States and in Rostock, Germany, we are driven by how we work as much as what we deliver. We win together through collaboration, push ourselves to achieve more, bring forward ideas with confidence, and care deeply about the people we serve and the colleagues we work alongside. These values shape our culture and guide how we support our customers and each other every day.

What We Offer
  • Medical and dental insurance
  • Company-funded Health Savings Account (HSA)
  • Life insurance and disability coverage
  • 401(k) with company match
  • Tuition reimbursement and professional development
  • Bonus potential
  • A collaborative, team-oriented culture focused on growth
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