Manufacturing Engineer

SaniSure; Twinsburg (OH); On-site; USD 80,000 - 105,000; Full time

Job summary

A multinational manufacturer, SaniSure, is seeking a Manufacturing Engineer to enhance silicone extrusion processes. This role emphasizes improving production efficiency and quality within a controlled environment. Candidates should possess strong technical expertise and a proven track record in manufacturing engineering.

Qualifications

• Experience in rubber, plastics, or silicone rubber fabrication.
• 4+ years of experience in manufacturing engineering focusing on silicone extrusion.
• In-depth knowledge of extrusion equipment and tooling.

Responsibilities

• Develop and optimize manufacturing processes for silicone extrusion operations.
• Lead root cause analysis for process deviations.
• Collaborate with teams for new product introductions.

Skills

Analytical skills

Problem-solving skills

Troubleshooting skills

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Manufacturing Engineering

Bachelor’s degree in Chemical Engineering

Tools

ERP systems

Microsoft Office

Job description

SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines. This role is expected to be on-site.

We continue to be on a robust growth trajectory, via both organic and inorganic growth, as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.

Our primary offering includes high-value assembly solutions and a portfolio of market-leading products, including PharmaTainer bottles and carboys and related assemblies, Mixed4Sure mixing solutions, Flex4Sure bags and bag assemblies, Fill4Sure needles and needle assemblies, fittings, clamps and a wide range of silicone, braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fast-growth applications, such as cell and gene therapies.

SaniSure is a high-growth, nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure!

Summary

The Manufacturing Engineer is responsible for supporting and optimizing the extrusion manufacturing processes for silicone-based products. This role focuses on improving production efficiency, ensuring product quality, supporting new product introductions, and driving continuous improvement within a cleanroom or controlled environment. The ideal candidate has strong technical expertise in silicone extrusion and a passion for process development, troubleshooting, and operational excellence.

Essential Functions

• Develop, implement, and optimize manufacturing processes for silicone extrusion operations.
• Lead root cause analysis and corrective actions for process deviations, quality issues, and equipment down-time.
• Collaborate with cross-functional teams (Production, Quality, Engineering, Maintenance) to support new product introductions and process transfers.
• Design, validate and review existing extrusion tooling, dies, and fixtures to ensure optimal flow, dimension control, and surface finish.
• Input, monitor, and analyze process metrics to drive yield improvements, reduce scrap, and enhance product consistency.
• Write and update manufacturing documentation including work instructions, standard operating procedures (SOPs), process specifications, and validation protocols.
• Support and lead process validations (IQ/OQ/PQ) for new and existing extrusion lines.
• Implement Lean, Six Sigma, and 5S methodologies to improve process capability and reduce waste.
• Assist in equipment selection, layout planning, and capital projects related to extrusion capacity and capability enhancements.
• Train operators and technicians on new equipment and process changes.
• Perform other duties as assigned.

Education

Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Chemical Engineering, or related field.

Required Experience and Competencies

• Experience in rubber, plastics, or silicone rubber fabrication.
• 4+ years of experience in a manufacturing engineering role with a focus on silicone extrusion.
• In-depth knowledge of extrusion equipment, process controls, tooling, and materials (specifically silicone).
• Experience working in regulated industries (e.g., medical device, pharmaceutical, or bioprocessing).
• Strong analytical, problem-solving, and troubleshooting skills.
• Familiar with validation and quality system requirements (GMP, ISO 13485, etc.).
• Ability to work interdependently and as part of a team.
• Familiar with ERP systems, Microsoft Office and Industrial PC based systems.

SaniSure is an Equal Employment Opportunity Employer.

SaniSure does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at [e-mail] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

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