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 R&D, Operations, Process Engineering, Quality, and Customer Service on continuous improvements to products and processes. 

Scope includes:

• Project management and technical leadership during commercialization and post-commercial improvements to New Product Introductions, including product validation, process optimization, and cost reductions.
• Leading problem-solving, corrective, and preventative actions around product and manufacturing process concerns originating both external and internal to the organization.
• Supporting Sourcing of new items and Supplier Quality.
• Driving and facilitating assigned portions of product and process change management and control.
• Specifying and qualifying Capital equipment.
• Authoring and updating technical and process documentation as required

ESSENTIAL FUNCTIONS:

• Develop deep product knowledge to provide technical expertise to other functional areas.
• Analyze mechanical designs, including technical drawings and associated measurement systems.
• Plan and conduct product verification and validation testing and lead production transfer of new products.
• Work with Design Engineering and Manufacturing integrate a Design for Manufacture & Assembly and Design to Cost perspective during verification.
• Drive Capital equipment requests and qualification.
• Conduct labor and process studies.  Lead yield improvements, reduce variability, support manufacturing resolving technical problems and lead product cost reduction initiatives.
• Lead efforts to perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements.
• Support customer complaint investigations and analyze complaint data to identify and address systemic design issues. Propose design changes to resolve. Manage implementation and monitor effectiveness.
• Support audits, resolve CAPAs and NCRs, continuous improvement, remediation of existing design files to address changing regulations and/or changing test requirements.
• Provide engineering support for product compliance (REACH, ROHS, CE, etc.).
• Create supplier and component redundancy, perform design changes to reduce material and manufacturing costs, lead-times, and quality issues.
• Lead or support supplier changes to processes, design and/or materials. Resolve supplier issues.
• 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.  Author and update technical and process documentation as required.
• Interact with key company personnel both within Sanisure and external partners as related to product design and manufacturing. 
• Develop and maintain positive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements.
• Perform other duties as assigned.

QUALIFICATIONS:

• Bachelors’ 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.
• Ability to repurpose existing technologies or create new innovations to solve problems.
• Execution and documentation of Root Cause Analysis and corresponding Corrective Actions (CAPAs).
• Project management and strong organizational and time management skills. Detail and deadline oriented.
• High initiative with the ability to work independently and problem solve with minimal supervision or direction.
• Must have a strong work ethic and ability to communicate effectively, both verbally and in writing.  Strong interpersonal skills: ability to interact with staff at all levels within and external to the organization.
• Ability to organize inputs to generate a customer driven output.
• Experience working in a GMP (Good Manufacturing Practice) or laboratory environment.
• Ability and willingness to travel up to 10%, including occasional international.
• Preferred experience:
  1. Single Use Consumable design and development experience
  2. Experience working with multiple bioprocessing equipment suppliers.
  3. Biotech device development experience.
  4. Process characterization experience applying Design of Experiments to optimize manufacturing processes.
  5. Statistical Process Control (SPC) experience.

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.