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 Application Engineer for Bags and Bag Systems works closely with Sales and Product Line Management to translate customer requirements into engineered single-use bag solutions. Acting as a key technical liaison between internal engineering and external customers, this role drives product configuration, quoting support, design inputs, and application troubleshooting across SaniSure's bag product lines.
Essential Functions
- Develop deep product knowledge of SaniSure's single-use bag portfolio to provide technical expertise to Sales, Customers, and other functional areas.
- Serve as a customer-facing technical resource: confidently lead and respond to application inquiries, technical proposals, and customer counterproposals.
- Translate customer specifications and application requirements into engineering inputs, drawings, and bill of materials for bag assemblies.
- Support quoting activities by performing make/buy analyses, engaging external suppliers for pricing and qualification, and providing technical guidance to the commercial team.
- Apply knowledge of regulatory requirements to ensure bag solutions meet customer compliance needs.
- Collaborate with Manufacturing to evaluate Design for Manufacture & Assembly (DFMA) and Design to Cost (DTC) perspectives for bag assemblies.
- Lead or support root cause analyses and corrective/preventative actions (CAPAs) related to bag product complaints and quality issues.
- Participate in New Product Introduction (NPI) activities including product validation, process optimization, and post-commercial improvements.
- Support audits, respond to NCRs, and drive continuous improvement in design documentation and engineering change processes.
- Provide technical direction and guidance to less experienced Engineers and Drafters.
- Perform other duties as assigned.
Education
- Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, or related field); Master's degree preferred.
Required Experience & Competencies
- 7+ years of engineering experience in a biotechnology, pharmaceutical, or medical device manufacturing environment.
- Experience with single-use bag design, assembly, and application engineering for bioprocessing.
- Proficient in CAD software (2D and 3D) for building models and assemblies; able to create, read, and interpret technical drawings, BOMs, and specifications.
- Experience performing or supporting make/buy analyses and supplier qualification/onboarding activities.
- Strong customer-facing skills: able to present technical content, manage proposals, and drive technical alignment with external stakeholders.
- Execution and documentation of Root Cause Analysis and corresponding Corrective Actions (RCCA, CAPAs).
- Experience working in a GMP (Good Manufacturing Practice) environment.
- Project management and strong organizational and time management skills. Detail and deadline oriented.
- Adaptable and capable of working in a fast-paced environment; high initiative, sense of urgency, with ability to work independently.
- Strong work ethic with excellent verbal and written communication skills; ability to interact with staff at all levels within and external to the organization.
- Proficient with Microsoft Office Suite.
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, Biomedical, Chemical, or a related field
- Master’s degree in Engineering
- 7+ years of engineering experience in a biotechnology, pharmaceutical, or medical device manufacturing environment
- Experience with single-use bag design, assembly, and application engineering for bioprocessing
- Proficiency with 2D and 3D CAD software
- Ability to create, read, and interpret technical drawings, bills of materials, and specifications
- Experience with make-or-buy analyses and supplier qualification or onboarding
- Customer-facing technical communication, proposal management, and stakeholder alignment skills
- Root cause analysis and corrective action experience, including RCCA and CAPAs
- Experience working in a GMP environment
- Project management, organizational, and time management skills
- Strong verbal and written communication skills
- Proficiency with Microsoft Office Suite
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.
