Engineer III

Summary
This position reports to the Sr. Manager of Frontline Engineering in the Facilities and Engineering Department. The Utility Engineer is a subject matter expert in plant utilities (WFI WRO clean steam compressed air and plant steam) and supports manufacturing and utility operations at the Vacaville site.
Job Responsibilities
Technical:

• Identify analyze and design improvements and capabilities for facility utility process and equipment systems.
• Understand and provide technical support for all site utility systems including natural gas systems water pretreatment systems drain systems water for injection systems plant & clean steam systems cooling water systems lab vacuum air systems and bulk gas/chemical systems
• Support Roche/Genentechs Right to Operate and to Make Assess and Release our pharmaceuticals; ensuring our patients are able to receive an uninterrupted quality supply of their necessary prescriptions on time
• Develop and maintain engineering documentation such as PFDs P&IDs design drawings and specifications design review and protocols (FAT SAT and IQ).
• Support development and review of project documentation such as schedules budget URS PEP RFQs Contractor Bid Packages Statements of Work and Credit Applications.
• Drive and manage the planning and design phases including project initiation and conceptual/basic/detailed design depending on assignment.
• Daily process monitoring and analysis of manufacturing data engineering evaluation and support for discrepancy investigations and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation
• Support debug operational and performance qualification and handover to operations.
• Manage construction phases including contractors construction supervision Genentech business processes change orders punch-list turnover and closure.
• Immediate resolution of emergent issues; including troubleshooting process equipment and system malfunctions or failures on a 24/7 basis including weekends and holidays as necessary
• Support Global Engineering on major projects in a user team role.
• Collaborate with peers in continuous improvement of technical infrastructure including standards practices specifications procedures and business processes.
• Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems root cause analysis and ownership/sponsorship of corrective and preventative actions
• Provide technical guidance to utility operations technicians

Leadership & People Management:

• Individual Contributor

Job Requirements
Education:
BS Engineering degree from an accredited university. Electrical mechanical or chemical engineering is preferred.

Experience:

• 5-7 years of work experience in a GMP manufacturing environment for SE05
• 8-11 years of work experience in a GMP manufacturing environment for SE06

Knowledge/Skills/Competencies:

• S trong understanding and demonstrated ability with engineering principles and techniques.
• Knowledge of FDA and EMA cGMPs applicable building codes and related regulations.
• Proficiency in ISA standards and practices for instrumentation
• Knowledge of calibration theories techniques and practices
• Knowledge of project lifecycle including initiation design construction and commissioning/validation.
• Effective communication and interpersonal skills with technical operations maintenance quality and senior management personnel .

Work Environment/Physical Demands/Safety Considerations

• Work environment includes office utility clean room warehouse laboratory roof and outdoors.
• Physical demands require sitting standing walking climbing stairs ladders scaffolding and cleanroom gowning.

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.

Required Experience:

IC