Biotech Bag Systems Application Engineer

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

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.