Senior Process & Utility Engineer, Japan New Plasma Facility Project

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Job Description

OBJECTIVES/PURPOSE

• Ensure Process Equipment is “fit for purpose” for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements

• Main objectives (key services)

  • Technology selection

  • Review Capacity Modeling developed by Engineering company

  • Engineering and Equipment Design

  • Safety engineering design and management

• Recommend strategic preparation of project for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions

ACCOUNTABILITIES

• Acting as Process Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for process equipment. In detail, He/she will:

• Report to the engineering manager.

• Develop and maintain process equipment concepts and engineering scope based on approved budget and schedule.

• Ensure that all process equipment meet regulatory requirements, client specifications, and industry standards and define the user requirements.

• Collaborate with other project disciplines to ensure integrated design solutions.

• Guide and coordinate with external design company the procurement strategy packages definition related to its discipline.

• Review and approve design documents and concepts.

• Conduct gate keeping reviews.

• Review and approve contractor submittals.

• Lead commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment.

• With Partners in Engineering Validation support the Qualification and Validation activities for Process Equipment.

• Perform Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Black Utilities Operations, Maintenance, Calibration, Reliability, Automation.

DIMENSIONS AND ASPECTS

Interaction

• Manufacturing/Production, Utilities Operations, Instrument Calibration/Metrology, Spare Parts Manager, EHS, Engineering, Reliability Engineering, Sustainability Engineer

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Engineering degree or equivalent required; preferably, Chemical, Biochemical, Mechanical or Industrial engineering.

• Minimum 5 years of relevant experience.

• Expert of Process Unit Operations in Pharmaceutical Manufacturing.

• Understanding of Good Manufacturing Practices (GMP).

• Preferably, good knowledge / SME for machines/lines/systems and all of its components.

• Excellent verbal and written communication skills in English and Japanese.

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