Manufacturing Engineer (Onsite)

Job DescriptionJob Description

ABOUT SANISURE

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.
• Project management experience.
• 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 , , , , citizenship, ancestry, physical or mental , legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, , , , expression, , , 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 humanresources@sanisure.com 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.