The Engineer provides maintenance-centric technical support to the Drug Manufacturing organization to support their ongoing and future activities. They also represents the interest of Drug Manufacturing Maintenance to other organization for maintenance related issues, such as spare parts, maintenance and reliability strategies, reference documentation, and liaison with internal and external Biotech and maintenance organizations.
He/She also acts as a liaison and service provider to other Genentech groups such as manufacturing, engineering, MSAT, Quality, EH & S, legal, Facility Services, etc. to share information & needs, and identify opportunities for improved equipment reliability, and improved manufacturing consistency resulting from improved maintenance and equipment and equipment reliability and sterility or quality related issues.
· Preview pre-turnover maintenance plans for new projects.
· Represent maintenance on engineering projects and ensure the project turnover and documentation requirements contained in EP-G11 and 21 requirements, such as TOP’s, walk-throughs, coordinate development of training and PM SOP’s.
· Act as a consulting engineer for spare parts & quality matters, including like for like evaluation, substitutions, vendor reviews & evaluation, assistance with MRO stores.
· Spare parts evaluations for new and existing equipment.
· Participation in new equipment design and layout phase to ensure safe and effective equipment maintenance access and maintenance issues are addressed. In new equipment design phase participate to ensure system components are compatible with existing maintained systems where appropriate and ensure reliability / maintainability history of existing similar components is a key consideration.
· Working with EH & S to ensure adherence to all industrial and OSHA requirements and to assist with personnel safety initiatives related to maintenance.
· Identify and execute maintenance related small projects.
· Identify & execute areas in need of improved training or better maintenance procedures.
· Develop or revise Maintenance SOP’s to provide more specific, detailed component maintenance instructions (such as valve lists), and instructions surrounding post maintenance testing / checkout / turnover procedures.
· Discrepancy, Change Control Management (CR), CAPA, and Corrective Action management. Work with MQA, QEV and QA/QC to help prevent future discrepancies, and verify that corrective actions are completed.
· Equipment reliability research, trending and corrective actions.
· Participate and help ensure that maintainability, documentation, equipment accessibility, parts lists, etc. are adequately covered.
· Provide technical support to MRO stores to evaluate like-for-like substitutions of parts, equipment or repairs for parts and equipment.
· Provide advisory technical support to Manufacturing on proposed maintenance work or projects.
· Provide updates, reports and presentations to Managements, stakeholders and customers.
· Participates in teamwork and is expected to suggest project improvements.
· Works with others to generate support for assigned projects. Justifies goals to colleagues. Acts as a mentor for those with similar or less engineering expertise.
· Productive interactions across work groups and with outside collaborators on technical issues associated with specific projects.
SUPPLIERS AND CUSTOMERS:
Customers are primarily the Drug Manufacturing maintenance execution groups, but other organizations occasionally request advice from the Associate Engineer such as MSAT, Manufacturing Operations, MRO stores, corporate reliability and corporate engineering, EH & S, procurement, and corporate contract services.
Suppliers are primarily corporate engineering, and individual small project groups whose equipment generate the need for maintenance and maintenance issues. Other suppliers of materials and information are MRO stores, Manufacturing, outside vendors and suppliers, internal maintenance groups within Genentech, and outside trade organizations related to biotechnology, pharmaceutical and industrial maintenance work.
Education and Experience:
BS in Chemical Engineering, Mechanical Engineering or a related field, with a minimum of five years manufacturing systems experience and a thorough knowledge of engineering principles and applications is required.
Knowledge, skills and abilities:
Excellent communication skills and the ability to provide technical leadership in a cross-functional, cGMP regulated environment are essential. The ability to assess and develop timely, effective solutions and project plans for short and longer term manufacturing equipment and operations needs is required. This position requires some domestic and foreign travel.
Roche - 20 months ago
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...