9 days old

Senior MES Automation Engineer

Genentech
South San Francisco, CA 94080

We are looking for a highly motivated Senior MES engineer to be part of the Manufacturing Software Systems team within the South San Francisco Automation department. This individual will be part of a larger team of MES engineers supporting two MES systems. The South San Francisco site consists of both a Drug Substance site that utilizes the POMSnet MES system and a Drug Product site which is currently in the process of implementing the Pharmasuite MES system. Candidate must be a self-starter, who can independently drive projects and day-to-day work tasks to completion according to a defined budget and schedule. There is also the opportunity to learn the new DS standard Syncade MES system at the upcoming new manufacturing facility being built next door.

The Senior MES Engineer will provide subject matter expertise and technical leadership on the deployment of the DP MES Pharmasuite system as well as enhancement and lifecycle strategy for the POMSnet system.

Responsibilities

  • Provide extensive subject matter knowledge / experience with hardware and software development, implementation in support of Pharmasuite MES, including integration of ISA88 and ISA95 Batch Standards within the pharmaceutical industry.
  • Design and execution of large and/or strategic projects in line with overall department and plant strategies, including: project approach and resource needs, options analysis, execution plan, engineering document development, and system ownership through the project delivery life cycle of planning, design, implementation, installation, and qualification.
  • Author and maintain detailed design documents, system architecture diagrams and standard operating procedures.
  • Partners proactively with key customers, team members and stakeholders, while being open and approachable with a friendly, positive and professional attitude
  • Maintain all core GMP and SHE training at target level of 100% on time, and beforeperforming relevant work.
  • Provide 24/7 support to Manufacturing operations in group rotation
  • Participate in all activities required to support production, including but not limited to; MES user support, troubleshooting, investigations, periodic reviews, root cause analysis, safety and Quality preventative and corrective actions.
  • Ensure effective maintenance and availability of MES systems, interfaces and equipment. Support software and hardware life cycle management efforts to ensure systems remain current and compliant.
  • Support site audits and inspections and implement corrections as needed.
  • This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents.
  • Provide technical leadership, guidance and mentoring to staff including projects, continuous improvements and inspection/regulatory readiness initiatives.
  • Strong behaviors, which include Focus, Empower and take ownership, Make it Happen, Continuous Improvement and Go and see firsthand
  • Ability to work in an agile and ambiguous environment
  • Commitment to quality
  • Growth mindset
  • Servant leader with strong coaching skills

Qualifications

  • B.S. Degree in Engineering or related discipline with 8+ years of experience in pharmaceutical/biotech with working experience of Pharamsuite MES system
  • Experience working with multiple control system platforms (i.e DeltaV, Allen-Bradley)

  • Experience working with PL/SQL

  • Proven ability to execute large complex MES automation projects in a GMP environment.
  • This position requires strong adherence to compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents.
  • The successful candidate must have strong initiative and integrity as well as strong interpersonal, written and verbal communication skills. They should be able to successfully work independently and within teams, demonstrate strong problem solving skills, partner/customer focus, and the ability to work with complex business systems and processes.

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Posted: 2020-05-20 Expires: 2020-06-19

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Senior MES Automation Engineer

Genentech
South San Francisco, CA 94080

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