Sustaining Engineer

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 Sustaining Engineer works closely with Process Engineering, R&D and Quality teams across the organization to lead and drive project engineering and process improvement efforts of existing and newly launched products. The sustaining engineer will be the focal person for all technical issues in manufacturing and the field, providing project management and technical leadership for improvements, enhancements and extensions of current products. Reports to the NPI Manager/Process Manufacturing Manager (sustaining engineering is more aligned with post commercial release support than NPI) and works closely with R&D, Operations, Quality and Product Management. Interacts with key company personnel both within Sanisure and external partners as related to product design and manufacturing. Develops and maintains positive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements. Based in office at Sanisure R&D center in Camarillo with up to 10% travel

ESSENTIAL FUNCITONS:

• Plan pre-production verification and validation testing and lead production transfer of new products.
• Work with Manufacturing and Design Engineering to advocate and integrate a Design for Manufacture & Assembly perspective during pre-production verification.
• Lead the effort to perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements.
• Support driving full documentation of design including, BOM, drawings, engineering change control and procedures.
• Ensure process and design changes are documented and adhere to industry quality standards
• Support audits, resolve CAPAs and NCRs, continuous improvement, remediation of existing design files to address changing regulations and/or changing test requirements.
• Support customer complaint investigations and analyze complaint data to identify and address systemic design issues. Propose design changes to resolve issues, manage implementation and monitor effectiveness.
• Develop strong product knowledge to provide technical expertise to other functional areas.
• Analyze mechanical designs.
• Lead yield improvement, reduce product variability, support manufacturing resolving technical problems and leading product cost reduction initiatives.
• Support design verification testing and perform process verification / validation.
• Create supplier and component redundancy, perform design changes to reduce manufacturing cost, lead-time and quality issues.
• Lead or support supplier changes to processes, design and/or materials. Resolve supplier issues.
• Provide engineering support for product compliance (REACH, ROHS, CE, etc.).
• Other duties as assigned

QUALIFICAIOTNS

• Bachelor’s degree in engineering; Masters preferred.
• 8+ years hands-on design and development in plastic design and manufacturing or related industry.
• Design verification and process verification/validation protocol and report writing
• Design control, change control and risk management experience (DFMEA, PFMEA)
• In depth knowledge of creation of 2D and 3D drawings and related Bill of Materials is desired.
• Execution and documentation of Root Cause Analysis and corresponding Corrective Actions (CAPAs)
• Project management and strong organizational skills.
• Self-starter must be able to work independently with minimum supervision or direction.
• Must have a strong work ethic and ability to communicate effectively, both verbally and in writing.
• Experience working in a GMP (Good Manufacturing Practice) or laboratory environment
• Single Use Consumable design and development experience
• Experience working with multiple bioprocessing equipment suppliers.
• Biotech device development experience
• Process characterization experience applying Design of Experiments to optimize manufacturing processes
• Design for Manufacture & Assembly (DFMA) experience reducing cost and quality issues
• Statistical Process Control (SPC) experience
• Ability to establish sound working relationships.
• Travel up to 10%.
• High initiative with the ability to work independently and problem solve.
• Ability to organize inputs to generate a customer driven output.
• Ability to repurpose existing technologies or create new innovations to solve problems.
• Detail & deadline oriented; well organized.
• Excellent verbal and written communication skills.
• Strong interpersonal skills: ability to interact with staff on all levels

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 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.