Senior Container Closure Expert (PFS / Cartridges)

About the role

Roche is seeking a senior expert to lead the development of container closure systems for prefilled syringes and cartridges. The role combines hands‑on engineering, design control, and cross‑functional collaboration to bring combination products from development to market.

Key responsibilities

• Serve as technical lead and subject‑matter expert for combination products and medical devices, guiding them from development through commercialization.
• Develop and evaluate container closure designs, ensuring integrity, fill‑finish performance, and compliance with regulatory standards.
• Provide external technical oversight on mechanical designs with partners, ensuring robustness and innovation.
• Lead structured problem‑solving investigations and root‑cause analyses for device and container issues.
• Author design control documentation, risk assessments, and conformity assessments in line with ISO 13485, 21 CFR 820, ISO 14971 and related standards.

Required profile

• University degree (BSc or MSc) in engineering or a related technical discipline.
• 5+ years of experience in mechanical engineering and drug‑delivery device development within pharma or highly regulated environments.
• Deep expertise in primary container materials (glass, COP/COC polymers, elastomers, functional coatings) and extractables/leachables.
• Proven technical leadership, problem‑solving skills, and ability to work in cross‑functional teams.
• Fluency in English; German is a plus.

Required skills

• Mechanical engineering
• Container closure systems for prefilled syringes and cartridges
• CCI testing, elastomer and coating chemistry
• Fill/finish technology and stoppering
• Design control documentation (DDP, URS, DIs, DOs, DVPs)
• Regulatory standards: ISO 13485, 21 CFR 820, ISO 14971, USP <1207>, USP <381>, USP <660>