Job Details

Job Responsibilities:

• Develop and qualify global primary and secondary packaging solutions for sterile, non-sterile and combination products, incl. author/co-author the related packaging specifications and qualification documentation
• Qualification of global packaging solutions in line with the current validation requirements (e.g. Development of test protocols and reports, risk assessment, execute IQ/OQ/PQ, and shipping qualification)
• Maintenance of global packaging solutions (e.g. support change control records, provide impact assessments, execute requalification)
• Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements
• Support or lead projects delivering innovative packaging technologies and systems under Roche global packaging technology centers

• Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related field
• At least 1 year working experience in relevant field
• Proficient technical leadership, collaboration and communication skills
• English language proficiency required

• Knowledge of packaging testing methodologies and standards including, shock, drop and vibration testing, peel force and tensile testing, barrier analysis, CCI/Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validation
• Knowledge of packaging process equipment, related to steriles, and non-steriles, and combination products packaging activities (e.g. vials, PFS, devices, aseptic form/fill/seal, blister and bottle filling lines), printing systems and serialization
• Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities
• Knowledge of design control for combination products
• Working knowledge of computer systems including TOPS, CAD or Solidworks, and Microsoft tools including MS project, and Adobe
• Knowledge of industry best practices and technical writing skills such as GMP and GDP