Application Engineer - Single Use Bag Solutions

SaniSure; Camarillo (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

SaniSure is seeking an Application Engineer for Bags and Bag Systems to translate customer requirements into engineered bag solutions. You will act as a technical liaison between internal engineering and external customers, driving product configuration, quoting support, design inputs, and troubleshooting across bag lines.

The role requires 7+ years in biotech/pharma manufacturing, CAD proficiency, and experience with single-use bag designs.

Qualifications

• 7+ years of engineering experience in biotechnology, pharmaceutical, or medical device manufacturing.
• Experience with single-use bag design, assembly, and application engineering for bioprocessing.
• Proficient in reading and creating technical drawings, BOMs, and specifications.
• Experience performing make/buy analyses and supplier qualification/onboarding.
• Strong customer-facing skills to present technical content and drive alignment.
• RCCA/CAPAs and root cause analysis documentation.
• Experience in GMP environments.
• Project management and organizational skills; detail- and deadline-oriented.
• Ability to work independently in a fast-paced setting.

Responsibilities

• Develop deep product knowledge to provide technical expertise across sales, customers, and functions.
• Serve as a customer-facing technical resource for inquiries, proposals, and counterproposals.
• Translate customer requirements into engineering inputs, drawings, and BOMs for bag assemblies.
• Support quoting through make/buy analyses and supplier engagement for pricing and qualification.
• Ensure regulatory compliance of bag solutions.
• Collaborate with Manufacturing on DFMA and DTC perspectives for bag assemblies.
• Lead or support CAPAs related to bag product issues.
• Participate in NPI activities including product validation and process optimization.
• Support audits and NCR responses; drive design documentation improvements.
• Provide guidance to junior engineers and drafters.

Skills

CAD software

BOM interpretation

Customer-facing

Root cause analysis

GMP experience

Project management

Regulatory compliance

Technical documentation

MS Office

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

CAD software (2D/3D)

MS Excel

ERP/PLM systems

Job description

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.