Manufacturing Engineer (Onsite)
Manufacturing Engineer (Onsite)
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Salary Not Disclosed
1 Vacancy
Job 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
Bachelors 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 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 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.
Employment Type
Full Time
