Technical Training Specialist, MFG Intervention Team (MIT)

Job description

·  Job facts

Please note:This is a local hire only designated position, as relocation assistance is not available for the position

Summary

Develop and improve departmental capabilities in automation systems, both directly and of manufacturing technicians. Provide coordination and issue resolution across Biochemical Manufacturing Operations, other groups and/or projects. Maintain quality system records in compliance with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Perform critical, technical troubleshooting, training, and documentation within the Quality system. Manage, lead, and implement operational excellence efforts to solve complex problems while maintaining required levels of safety, quality, regulatory compliance, and production. The Training Specialist is an integral member of the Manufacturing Compliance group, identifies compliance gaps within the Manufacturing, and leverages training and automation expertise and the compliance team to address and improve compliance. Allemployees in GMP Services are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities.

Job Responsibilities

Primary trainer for MIT onboarding program

·  Manage and oversee the MIT training program
·  Provide on the floor training support for MIT trainees, across all shifts
·  Ownership of MIT Web Based Training program training material, as required to maintain, sustain or create relevant content.
·  Development and application of OP4 Dev environment intervention practice problems to supplement the on the job training period, including maintenance of curriculum relevance
·  Train other support groups as needed (i.e. Maintenance and Utilities), to ensure that proper knowledge of automation is transferred to all frontline operations (Mfg, Maintenance)

MIT Business process support

·  Develop and manage long term program strategy providing recommendations to MLT/MELT as needed
·  Manage the manufacturing intervention business processes: intervention decision tree, work instructions and associated procedures (e.g. SOP01999)
·  Primary Automation Intervention service level call review, support and troubleshooting, as required
·  Communication point of contact for MIT floor issues at appropriate SQDECs and site huddles, work as the liaison between manufacturing and automation for MIT related issues
·  Review and trending of Automation log intervention data in order to provide input for focus team change prioritization, compliance risks, and required communication and training updates
·  Oversee manufacturing with timely QRM interventions and management of exception comments, as needed
·  Manage MIT Trackwise action items requests as needed.
·  Fills in as a backup when needed to address on the floor issues
·  Responsible for the lifecycle management of the MIT program building capabilities to own/enhance system
·  Collaborate with stakeholders to identify and develop automation change process improvements.

Manufacturing Automation Technical Support

·  Manufacturing liaison for automation change implementation processes (UDC, Commissioning, etc) and improvements to drive more efficient, right first time changes
·  Support creation of User Requirement Specifications/Functional Requirement specifications /Detail Design Specification, and lifecycle documentation to correspond with control software
·  Provide automation support for equipment/software field testing, and commissioning and enable other MIT technicians to support.
·  Assist with troubleshooting process equipment and critical process utility systems
·  Support process technical transfers and implementation of significant engineering changes through the development of scope and execution of debug and on the floor testing
·  Manage and resolve technical and compliance issues that impact multiple functions following cGMP regulation and applying advanced theory, technical principles, and expert judgement

Job Requirements

Education and Experience

·  BS/BA in Life Sciences/Engineering preferred, and at least 5 years' experience in the pharmaceutical, biopharmaceutical industry or a combination of education and experience.
·  Automation system troubleshooting experience required
·  Ability to make sound decisions, solve complex problems, and teach others troubleshooting skills

Knowledge, Skills and Abilities

·  Delta V Control Studio, Explorer and Batch Navigation
·  OP4 Delta V, Delta V Historian, MES Access
·  Experience troubleshooting and fielding calls from Manufacturing is preferred
·  Complete DV Operate Training Modules
·  Understand GMPs and how to support different department's requests
·  OP4 Dev System set up and practice problem execution
·  Electronic Batch Report / Data Analytics
·  Understand the discrepancy process, Trackwise child record closure requests
·  Strong technical knowledge of Upstream and Downstream process and associated equipment
·  Understand MFG Equipment, related SOPs and relationship to the process.
·  Good communication skills required to discuss floor issue with MTS, MQA, and SciEng
·  Shift flexibility will be required, working hours outside of your normal shift to support 24/7 manufacturing
·  Authorized trainer for Delta V user
·  Trackwise change owner, CAPA owner

Work Environment / Physical Demands / Safety Considerations

·  Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.
·  Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a load environment.
·  May work with hazardous materials.

Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties and to assign other duties as necessary.

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Roche is an equal opportunity employer.
Customer Support, Customer Support > Technical & Application Support

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.