Job Description

Engineering Manager - Cape TownThe PositionRoche Diagnostics in Cape Town has an opportunity for an Engineering Manager.This role will enable you to own the engineering and maintenance activities in the Cape Town Operations team. You will manage a team of engineers with the focus on purchasing and maintenance activities of manufacturing equipment.Key Challenges:Develop and lead the Cape Town Engineering team.Work at the interfaces of Global Sequencing Operations Network and local Cape Town Operations (QC, validation, enzyme manufacturing, bulk manufacturing and filling and labeling) organization.Management of the maintenance and calibration program. Creating and delivering preventive and predictive maintenance and repair to critical equipment in a regulated scientific environment. Ensuring that all instrumentation/standards used to calibrate equipment have a valid calibration certificate.Perform and/or manage unplanned equipment maintenance (corrective maintenance).Manage and develop a high performing team according to Roche global standards to ensure the Cape Town organization is a great place to work (for example check-ins, development plans etc.).Manage and execute on project, budget and resource planning of all equipment related activities. Align with production planning, Cape Town Operations, and finance.Plan, manage and document existing equipment regarding maintenance, calibration, and spare parts. Coordinate equipment installation planning with Site Management and Cape Town Operations managing the process end to end. Coordinate equipment changes according to equipment change control guidelines.Plan, manage and document inventory replenishment for Cape Town Operations.Define specifications of equipment for fermentation, bulk manufacturing, filling and labeling, QC and packaging in accordance with manufacturing capabilities and marketing objectives.Apply engineering principles and financial expertise to improve diagnostic biologic manufacturing performance and promote cost reductions to achieve optimum level of quality and efficiency. You may be required to direct cross-functional personnel on specific projects.Establish new equipment and processes - Use your technical and business knowledge and expertise to support Operations in the design, maintenance, scale-up, optimization, automation, troubleshooting and validation of manufacturing processes and equipment. Prepare the requirements, bid package, capital justification and Installation/Operational Qualification for all new processing, filling and packaging equipment. Work closely with indirect procurement and suppliers to source, manage, repair and commission new equipment; handing over equipment with appropriate documentation upon commissioning.Serve as project manager for all CAPEX, manage URS writing/maintenance and support the physical move of equipment. Author, complete and maintain PPM forms for equipment.Design and/or perform studies to assist Operations in the monitoring of processes, equipment and facilities to optimize efficiencies, increase capacity, incorporate process changes, monitoring of equipment performance, responsible for up-time of equipment etc. Present recommendations to the Operations Leadership Team.Engineering SME for the site setup. Coordinate Cape Town operations activities and serve as the interface for the new site PM, Global Engineering and Network Lead.Manage the Data Management System (DMS) xe2x80x93 Perform weekly physical checks of rooms and equipment, responding to alarm messages and transferring stock where appropriate. Liaison with service provider when DMS equipment/rooms need to be connected, corrected, or disconnected. Perform DMS temperature trend analysis and provide monthly KPI reports to the Operations team. Liaison with scientists for Non-Conformance Records (NCRs). Work closely with IT, Site Service, Facilities, Process Development, Regulatory Early Development and Logistics to coordinate DMS execution.Develop and implement an Operations Support function.Support and/or own process and/or continuous improvement projects with the team.Supports and/or own non-conformance records (NCRxe2x80x99s) and/or CAPAxe2x80x99s with the team.Represent the Engineering team during Audits.Other duties as assigned.You, as an ideal candidate, will have the following skills, experience and education:Required Qualification: Engineering degreeRequired Experience: At least 5 years of experience in manufacturing engineering, preferably in a biotech or diagnostic equipment industry, with management and leadership experience. Knowledge of engineering principles, manufacturing process flow, analysis, diagnostic equipment and packaging components is highly desirable as well as working knowledge of document control and ISO 13485/GMP/IVD.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, wexe2x80x99ve become one of the worldxe2x80x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

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