The purpose of this position is to provide engineering support to Operations including oversight of product packaging design/implementation, filling/packaging equipment, participation in project teams (e.g. equipment upgrades, product launches), specifying/purchasing new equipment, supporting customer complaint investigations and supporting Operations documentation changes.
This is a senior level within the Manufacturing Engineer job series.
Packaging Engineer/SME familiar with design, modification, testing and implementation of primary and secondary packaging components for medical device/diagnostic manufacturing, including vials, bottles, vessels, containers, closures, labeling, cartons and shippers.
Previous experience with packaging components testing, including ISTA 2A testing (drop testing, compression testing, vibration testing) procedures and interpretation of results, Dangerous Goods shipping/testing requirements, leak detection, leak testing, blister burst testing, peel testing, temperature monitoring of shipments and cold chain practices.
Previous direct interaction with primary and secondary packaging component suppliers on design changes, specifications and managing tooling build projects.
Familiar with execution of engineering studies and/or component verification tests to verify changes/modifications to packaging components.
Familiarity with plastics processing (e.g. Injection molding, extrusion, vacuum forming), tooling, and resin types.
Working knowledge of AutoCad for Packaging design/changes, palletization optimization/configuration and engineering support.
Lead larger scale projects supporting Operations or for product launches.
New/Current equipment support Operations by specifying, purchasing, installing and commissioning equipment, typically smaller scale, standalone equipment.
Lead in execution of engineering studies and factory acceptance tests.
Support equipment qualification process and draft operational SOP s for equipment.
Prepare production documents (e.g. filling records, packaging records, and label records) as needed.
Investigate customer complaints in an engineering support capacity.
Packaging improvement and development activities, including revising and creating primary and secondary packaging components, and associated specifications.
Provide a technical role model to others.
Performs other duties as assigned.
Bachelor s degree in Engineering or related field, or equivalent combination of education and work-related experience.
BS in Packaging Engineering, Mechanical Engineering or Materials Engineering preferred.
10+ years experience in manufacturing engineering, preferably in a biotech or diagnostic equipment industry.
Knowledge, Skills, and Abilities:
Expert knowledge of manufacturing engineering principles; manufacturing process flow, analysis, diagnostic equipment and packaging components preferred
Previous experience in and familiarity of GMP manufacturing environment in FDA-regulated industry preferred.
Some domestic/international travel may be required
Who we are At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we ve become one of the world s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.