Job Summary : The Senior Manufacturing Engineer will play a pivotal role in shaping and optimizing Roche's diagnostic manufacturing processes, ensuring high efficiency, quality, and compliance with regulatory standards.
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.
This position is fundamental to advancing production capabilities, driving cost reductions, and leading cross-functional projects within filling and packaging streams.
The role offers a unique opportunity to influence the future of manufacturing operations while working in a mission-driven environment focused on innovation and healthcare impact.
Skills : ENGINEER, GMP Key Responsibilities :
- Define and establish specifications for new equipment and packaging components aligned with manufacturing and marketing objectives.
- Lead and manage project activities for filling and packaging manufacturing streams, ensuring timelines and deliverables are met.
- Support operations in designing, scaling, optimizing, automating, troubleshooting, and validating manufacturing processes and equipment.
- Prepare user requirements, bid packages, capital justifications, and acceptance strategies for new manufacturing equipment.
- Draft and execute equipment qualification protocols and test method validations for automated filling and packaging equipment.
- Create and maintain manufacturing documentation, including SOPs, records, and purchasing specifications.
- Identify and implement process improvements to reduce equipment downtime, minimize mean time to repair, and improve throughput yield.
- Ensure compliance with cGMP, ISO, and FDA standards in all manufacturing activities.
- Lead and facilitate cross-functional teams, communicating project status and resolving critical issues to achieve operational excellence.
Recruiter Insights :
High-impact role central to operational excellence and future manufacturing innovations at Roche.Opportunity to lead key projects with autonomy in a globally recognized healthcare company.Exposure to both U.S.and international manufacturing sites and suppliers, broadening professional experience.
Preferred skills such as automation implementation, injection molding, and design transfer are valued, offering a broader candidate pool.Potential for contract extension or full-time hire based on performance, providing career growth prospects.Candidate Insights :
Join a mission-driven team dedicated to advancing healthcare and improving patient outcomes.Hands-on involvement in state-of-the-art manufacturing equipment and process optimization.Collaborative, cross-functional project leadership within a supportive, innovative culture.Exposure to advanced technologies like surface treatment, adhesive bonding, and microdispensing.Competitive advantage : Opportunity to influence large-scale manufacturing improvements and gain global experience, with possibilities for long-term career development.