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Engineer III
Ref No.: 18-08978
Location: cc, California
This position is in the Global Biologics Manufacturing Science and Technology group, which supports GMP manufacturing of Roche products at internal Roche/Genentech and partner sites. This position will primarily focus on leading cross-functional projects, troubleshooting manufacturing and supplier issues, and aligning technical experts to define best practices for Single-Use Technologies (SUT) across the Global Biologics Manufacturing Network. In this position, you will need to provide scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role. Full working knowledge and experience with Single-Use equipment qualification, design and operation is highly preferred, although not required.
Essential Duties
Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
Lead and/or participate in global initiatives and cross-functional investigation and project teams
Work collaboratively with Global Manufacturing Science and Technology (gMSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network
Provide leadership as the business process owner for the management of multi-site vendor initiated changes (VICs) impacting single-use technologies
Assist supplier quality groups as a technical assessor for VICs
Provide guidance to the global manufacturing network in order to assure consistent and timely VIC assessments are delivered
Develop training materials and provide training sessions as needed
Define metrics to monitor the business process performance in order to recommend future improvements
Expand the implementation of the multi-site business process to account for material categories other than the single-use category
Represent GBMSAT and the single-use category in meetings such as the Material Review Board (MRB) and the Single-Use Category Team (SUCat) and Supplier Quality Management (SQM) meetings as required
Support single-use technologies at Roche manufacturing sites
Define the current state of SUT conformance compared to Roche standards
Identify gaps and propose a remediation plan to mitigate potential compliance risks
Align VIC management practices with internal Roche standards and multi-site VIC processes
Support technology transfers, audits, and regulatory filings pertaining to new and existing SUT items (e.g. antifoam bags, bioreactors, tubing sets, sampling containers, etc.)

Self-motivated, able to work independently as well as in teams. Excellent organizational and communication skills (both written and verbal)
Demonstrated proficiency in leading teams, experience leading cross-functional or cross-site teams is a plus
Proven ability to influence beyond direct line reporting relationships including to senior management
Experience with change control is required
Strong problem-solving and troubleshooting skills to support polymer chemistry analysis
Full working knowledge and experience with Single-Use equipment qualification, design and operation is a plus