Application Engineer - Single Use Bag Solutions

Sanisure; Camarillo, Northern (CA, KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

SaniSure, a Camarillo-based biotech device manufacturer, seeks an Application Engineer for Bags and Bag Systems to translate customer requirements into engineered bag solutions. You’ll act as the technical liaison between Sales, Product Management and customers, guiding product configuration, quotes, design inputs and application troubleshooting across the bag portfolio.

Requires 7+ years in biotech/pharma or medical device manufacturing, CAD (2D/3D), GMP experience and strong cross‑functional

Qualifications

• Bachelor's degree in Engineering required; Master's preferred.
• 7+ years in biotech/pharma or medical device manufacturing.
• CAD proficiency for 2D/3D models, drawings, and BOMs.
• Make/buy analysis and supplier qualification experience.
• GMP experience and strong documentation discipline.
• Strong customer-facing communication and proposal management.

Responsibilities

• Develop deep product knowledge of SaniSure's bag portfolio to provide technical expertise.
• Serve as a customer-facing technical resource and lead inquiries, proposals, and counterproposals.
• Translate customer specifications into engineering inputs, drawings and BOMs for bag assemblies.
• Support quoting with make/buy analyses, supplier engagement, and pricing guidance.
• Apply regulatory knowledge to ensure compliant bag solutions.
• Collaborate with Manufacturing on DFMA and DTC considerations.
• Lead or support CAPAs related to bag product quality issues.
• Participate in NPI activities including validation and process optimization.
• Assist audits, respond to NCRs, and drive design documentation improvements.
• Mentor junior engineers and drafters.

Skills

Customer-facing

Project management

Problem solving

Regulatory awareness

Mentoring

Education

Bachelor's in Engineering

Master's degree preferred

Tools

CAD 2D/3D

BOM & drawings

MS Office

Job description

Application Engineer - Single Use Bag Solutions

Regular - Full Time Camarillo, CA, US

Salary Range: $120,000.00 To $150,000.00 Annually

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.