Senior Process 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 companies

  • Engineering and Equipment Design

  • Safety engineering design and management

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

ACCOUNTABILITIES

• Acting as a 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 the approved budget and schedule.

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

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

• Guide and coordinate with the external design company on the procurement strategy and procurement package 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, Utilities Operations, Maintenance, Calibration, Reliability, Automation.

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; for example Chemical, Biochemical, Mechanical or Industrial engineering is preferred

• Minimum 5 years of relevant experience

• Expert of Process Unit Operations in Pharmaceutical Manufacturing

• Understanding of Good Manufacturing Practices (GMP)

• Good knowledge / SME for machines/lines/systems and all of its components is preferred

• Excellent verbal and written communication skills in English and Japanese

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