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Associate Process Engineer, MS&T

Forge Biologics is at the forefront of gene therapy development, looking for an Associate Process Engineer to enhance manufacturing processes while collaborating across multiple teams.

Skills

  • Problem-solving
  • Communication
  • Teamwork
  • Analytical skills
  • Technical documentation understanding

Responsibilities

  • Support engineering studies and continuous improvement projects
  • Contribute to Technology Transfer activities
  • Assist in the development of project justification and capital planning processes
  • Participate in factory acceptance testing and site acceptance testing for new equipment
  • Create and update operation and maintenance documentation

Education

  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology or related field

Benefits

  • Health, Dental, and Vision insurance
  • Competitive paid time off plan
  • Annual bonus for all full-time employees
  • 401(K) company match
  • Onsite fitness facility
To read the complete job description, please click on the ‘Apply’ button
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Average salary estimate

$70000 / YEARLY (est.)
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$60000K
$80000K

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What You Should Know About Associate Process Engineer, MS&T, Forge Biologics

Join Forge Biologics in Columbus, Ohio as an Associate Process Engineer, where you'll be part of a pioneering team focused on transforming gene therapy from concept to reality. At Forge, we're dedicated to empowering innovators in the gene therapy space, and you'll play a crucial role in enhancing our gene therapy manufacturing processes within the Manufacturing Science and Technology (MS&T) department. You'll collaborate closely with talented professionals across R&D, quality assurance, and regulatory teams, working on process optimization and feasibility evaluations to ensure our processes are efficient, compliant, and scalable. As you assist in technology transfer activities and contribute to continuous improvement initiatives, you’ll help drive operational efficiency and product consistency. Whether you’re conducting equipment testing, supporting troubleshooting efforts, or drafting vital documentation, your expertise will be vital for the seamless production of gene therapies designed to change lives. If you hold a Bachelor’s degree in Chemical Engineering or a related field, along with some hands-on experience in manufacturing operations, you might be the ideal candidate to embody Forge's core values of hard work, openness, purpose-driven focus, and engagement. Step into a vibrant work environment at our state-of-the-art facility, and be part of a team that’s making a significant impact on patient care.

Frequently Asked Questions (FAQs) for Associate Process Engineer, MS&T Role at Forge Biologics
What are the key responsibilities of an Associate Process Engineer at Forge Biologics?

As an Associate Process Engineer at Forge Biologics, you will implement new process equipment and optimize gene therapy manufacturing processes. Your role involves partnering with cross-functional teams to ensure that various processes are scalable and compliant. Key responsibilities include conducting engineering studies to drive operational efficiency, assisting in Technology Transfer activities, participating in equipment testing phases, and providing troubleshooting support for manufacturing processes and equipment.

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What qualifications are required for the Associate Process Engineer position at Forge Biologics?

Forge Biologics seeks candidates with a Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related fields, along with at least 1 year of experience in MS&T or GMP Manufacturing Operations. A foundation in drug substance and product manufacturing, knowledge of engineering drawings, and strong problem-solving skills are also essential.

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How does the Associate Process Engineer contribute to technology transfer at Forge Biologics?

The Associate Process Engineer plays a crucial role in technology transfer at Forge Biologics by participating in equipment gap assessments, process mapping, and the implementation of new systems. By assisting with pFMEAs and drafting project justification documents, you ensure that the gene therapy processes transition smoothly into manufacturing, reflecting their commitment to operational excellence.

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What opportunities for professional development are available for Associate Process Engineers at Forge Biologics?

At Forge Biologics, Associate Process Engineers have access to various professional and personal development resources. This includes training programs, mentorship opportunities, and engagement in innovative projects designed to enhance their skills and grow their careers within gene therapy manufacturing.

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What are the work environment and culture like at Forge Biologics for an Associate Process Engineer?

The work environment at Forge Biologics is fast-paced and collaborative, emphasizing clean communication and teamwork. As part of a diverse and driven group, Associate Process Engineers contribute to a purpose-driven mission, embodying core values of hard work, openness to feedback, and engagement in innovative solutions for gene therapies.

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Common Interview Questions for Associate Process Engineer, MS&T
Can you describe your experience with process optimization in manufacturing?

In answering this question, you should highlight specific projects where you implemented changes that led to improved efficiency or reduced costs. Discuss the methodologies you used and any metrics you can provide that demonstrate the impact of your contributions.

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What processes do you believe are crucial for successful technology transfer in gene therapy manufacturing?

Focus on the importance of thorough documentation and communication between teams, the role of feasibility studies, and the necessity of mechanic and process assessments. You could mention past experiences where you had to navigate these challenges and how you ensured a smooth transition.

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How would you approach troubleshooting a technical issue with process equipment?

Outline a systematic process for troubleshooting, such as identifying the issue, gathering relevant data, and collaboration with team members. Mention any tools or methods you have previously used to diagnose and resolve equipment issues.

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What are your thoughts on compliance in a cGMP manufacturing environment?

Discuss your understanding of cGMP regulations and the role they play in ensuring product quality and patient safety. Share examples of how you have ensured compliance in past roles and how you stay updated on best practices and regulations.

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Describe a time when you had to work with cross-functional teams. What was your approach?

Provide an example of a project where teamwork was essential, detailing how you maintained clear communication and leveraged the strengths of team members from different departments. Highlight the positive outcomes that resulted from collaborative efforts.

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How do you prioritize tasks when working on multiple engineering projects?

Discuss your organizational skills and any specific tools or methodologies (such as Agile or Kanban) that you employ to manage your projects effectively. Emphasize your ability to adapt to changing priorities while maintaining focus on key deliverables.

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What motivates you to work in the field of gene therapy manufacturing?

Share your passion for improving patient outcomes through innovative therapies. Discuss any personal connections or experiences that drive your interest in biotechnology and how this aligns with the mission of Forge Biologics.

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What do you see as the biggest challenge in gene therapy manufacturing today?

Reflect on current industry challenges such as regulatory hurdles, technological advancements, or scalability issues, and offer thoughtful insights. Discuss how you would address these challenges within your role at Forge Biologics.

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Can you explain the importance of documentation in the manufacturing process?

Highlight the role of documentation in ensuring compliance, traceability, and quality assurance. Illustrate your experience with maintaining comprehensive SOPs and engineering documentation that support process consistency and regulatory compliance.

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What methods would you employ for continuous improvement within manufacturing operations?

Talk about methodologies like Six Sigma or Lean Manufacturing that you have either studied or applied. Provide examples of how you've helped implement continuous improvement initiatives in past roles and their outcomes.

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Enable access to life changing gene therapies and help bring them from idea into reality.

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DEPARTMENTS
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
SALARY RANGE
$60,000/yr - $80,000/yr
EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 22, 2025

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