About SaniSure
SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines.
As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.
Job Summary
The Value Analysis/Value Engineering (VAVE) Engineer works closely with Procurement, Finance, Design Engineering, Operations, and Quality on projects that deliver savings. This role provides project management and technical leadership for in-sourcing projects, second-sourcing, Design-to-Cost (DTC), Design-for-Manufacture (DFM), and Design-for Assembly (DFA) initiatives. Key responsibilities include driving product and process change management, specifying and qualifying capital equipment, and authoring technical and process documentation.
Essential Functions
- Work with Procurement and Finance to build the potential pipeline of savings projects. Conduct research and analysis to establish business valuation for each project.
- Plan and drive VAVE projects, starting with project charters that outline expected savings relative to investment required to capture the savings.
- Quantify, track, and report cost savings and cost avoidance associated with VAVE projects; partner with Finance to validate savings realization.
- Conduct Make/Buy analyses to support in-sourcing decisions.
- Conduct analyses for decision support around second-sourcing opportunities.
- Analyze specifications, designs, technical drawings, and Bills of Materials (BOMs).
- Plan and conduct product verification and validation testing and lead production transfer of updated products.
- Work with Design Engineering and Manufacturing to integrate Design for Manufacture & Assembly and Design to Cost perspectives during verification.
- Drive capital equipment requests and qualification activities.
- Conduct labor and process studies. Lead yield improvements, reduce variability, support manufacturing in resolving technical problems, and lead product cost reduction initiatives.
- 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.
- Support driving full documentation of design including BoMs, 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.
- Perform other duties as assigned.
Education
- Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, or related field).
Required Experience & Competencies
- 6+ years of hands-on design and development in plastic design and manufacturing or related industry.
- Demonstrated track record of leading VAVE, DTC, DFM, DFA projects with measurable business results.
- Design verification and process verification/validation protocol and report writing experience.
- Design control, change control, and risk management experience (DFMEA, PFMEA).
- In depth knowledge of creation of 2D and 3D models and drawings and related Bill of Materials.
- Project management and strong organizational and time management skills with high sense of urgency. Detail and deadline oriented.
- High initiative with the ability to work independently and problem solve with minimal supervision or direction.
- Strong work ethic with excellent verbal and written communication skills. Strong interpersonal skills and ability to interact with staff at all levels within and external to the organization.
- Experience working in a GMP (Good Manufacturing Practice) or laboratory environment.
- Ability and willingness to travel up to 10%, including occasional international travel for supplier visits.
Equal Employment Opportunity Policy
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender identity or expression, sexual orientation, national origin, citizenship status, uniform service member status, pregnancy, age (40 and over), genetic information, disability (mental and physical), or any other protected status in accordance with all applicable federal, state, and local laws.
Skills Required
- Bachelor's degree in Engineering, such as Mechanical, Chemical, Biomedical, or a related field
- At least 6 years of hands-on design and development experience in plastic design and manufacturing or a related industry
- Demonstrated experience leading VAVE, design-to-cost, design-for-manufacture, and design-for-assembly projects with measurable business results
- Experience writing design verification and process verification or validation protocols and reports
- Experience with design control, change control, and risk management, including DFMEA and PFMEA
- In-depth knowledge of creating 2D and 3D models, engineering drawings, and Bills of Materials
- Project management, organizational, and time management skills
- Ability to work independently and solve problems with minimal supervision
- Strong verbal, written, interpersonal, and cross-functional communication skills
- Experience working in a GMP or laboratory environment
- Ability and willingness to travel up to 10%, including occasional international supplier visits
What We Do
As your trusted Single-Use Technologies (SUT) expert, SaniSure® designs and manufactures components, fluid management systems, and custom assemblies for complex fluid paths and closed-system applications across bioprocessing and advanced therapies—from upstream processing through final fill. With expertise in single-use system design, materials, and manufacturing, SaniSure works directly with customers to develop solutions tailored to their specific process requirements. Its open-architecture approach provides the flexibility to integrate components and technologies based on application needs rather than being limited to proprietary configurations. SaniSure combines in-house engineering, prototyping, component manufacturing, and assembly capabilities with a global manufacturing footprint. This vertical integration provides greater control over component sourcing, design, manufacturing, and quality. Through its broad component portfolio, custom engineering capabilities, and integrated manufacturing operations, SaniSure helps biomanufacturers address complex fluid management requirements, reduce supplier complexity, and support reliable manufacturing operations.
