エージェント取り扱い求人

Process Engineering Associate Director, Japan New Plasma Facility Project

募集中
  • 勤務地
    大阪府
  • 職種
    その他製剤化/製造・生産関連職
  • 業種
    医薬品メーカー(先発医薬品)

募集要項

業務内容 OBJECTIVES/PURPOSE

Own 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

Capacity Modeling and Site Master Planning

Engineering and Equipment Design

Safety engineering design and management

“Factory Floor” Continuous Improvement/ Troubleshooting / System ownership

Own strategic preparation of sites for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions

Provides leadership to all engineering disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget#

The incumbent is responsible for improving existing equipment to minimize production downtime and provide leadership to all process equipment related investigations

Develop and implement strategies to ensure cost and time effective designs while ensuring innovation and adhering to user requirements while managing daily operational support

ACCOUNTABILITIES

Technology selection

Drive Cross functional stakeholder management with our Partners in Manufacturing e.g. Sciences and/or Pharmaceutical Sciences. Sponsor the evaluation and selection of new, state-of-the-art technologies and process equipment and applicable process equipment vendors (e.g. Robotics Single Use Technology)

Identify future industry trends and decide on strategies for process equipment/technologies

Own business case development for CAPEX investments in process equipment incl. Total Cost of Ownership (TCO) calculations

Manage Process Equipment Vendors and Architectural/Engineering firms in the delivery of CAPEX and OPEX projects in areas of responsibility

Capacity Modeling and Site Master Planning

Mentoring of Process Unit Operation Capacity models and identify capacity bottlenecks / constraints in GMP manufacturing processes / production process and in the utilities delivery systems

Apply knowledge of heat transfer, mass transfer, fluid dynamics, reaction kinetics to solve common process engineering problems

Engineering and Equipment Design

Own Front-End Engineering and Design activities in feasibility study and conceptual design phases

Sponsor Project Turnover Packages for Process Equipment are delivered to site and that critical engineering knowledge such as as-built drawings, operating and maintenance manuals, equipment and instrument data sheets, spare parts lists are maintained, remain accurate and up to date

Gather requirements from Stakeholders - such as from Quality, Manufacturing, Reliability, Maintainability, Automation, and EHS – to decide on Process Basis of Designs, specifications and designs for Process Equipment, Process Control Systems, Process Instrumentation and Process Safety Systems and Devices

Lead Scope of Work and RFx Packages for Process Equipment Vendors, Process Engineering Consultants, Architectural / Engineering services, Commissioning services and (Sub-) Contractors

Sponsor commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment

With Partners in Engineering Validation mentor the Qualification and Validation activities for Process Equipment

SME Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Utilities Operations, Maintenance, Calibration, Reliability, Automation

Safety engineering design and management

Conduct Process Hazard Analysis (e.g. PHA-Hazop) of hazardous manufacturing / production processes and incorporate improvements into the design of process equipment, process control, and process safety systems

Perform Design Reviews of all process equipment with relation to EHS and lead for the relevant changes

Own Investigations for process equipment and implement Corrective and Preventive Actions (CAPA)

“Factory Floor” Continuous Improvement/ Troubleshooting / System ownership

Provide leadership the Manufacturing and Maintenance departments with troubleshooting activities of Process Equipment on the factory floor

Owner continuous improvement activities for Process Equipment applying continuous improvement tools such as DMAIC, FMEA, RCA, identify improvements, design and implement improvements and sponsor 3rd level troubleshooting in collaboration with “Manufacturing” &” Manufacturing sciences”

Mentor Management of Change for Process Equipment in area of responsibility

Responsible for internal and regulatory Audits and Inspections

Engage in the Process Engineering Community of Practice (CoP) through sharing of best practices and lessons learned

DIMENSIONS AND ASPECTS

Technical Expertise:

Lead and mentor system/equipment specifications

Determine basic causes, and develop and then follow up on recommendations for corrective actions

Enable capabilities to perform troubleshooting on system/equipment

Lead customer service problems and recommend design improvements

Leadership:

Displays and drives culture of -ism, PTRB, safety, and quality into the organization

Be on the floor to study and train and recommend techniques to enable the team to improve existing equipment to minimize production downtime.

Good interpersonal skills and be able to work effectively and efficiently in a team environment as leader, mentor, trusted advisor.

Demonstrates strong communication skills to effectively communicate with all levels of professionals, both internal (local & global) and external

Coach, motivate, develop, recognize and mentor the engineering staff, including senior level engineers and managers. Being a mentor developing future leaders

Decision-making and Autonomy:

Decision making on organizational changes to build the required capacity/capabilities

Autonomy in decision making to the level of required alignment

Decision making of short/mid & long-term impacts

Interaction:

CAPEX Project Teams, Manufacturing Sciences, Quality, Manufacturing / Production, Utilities/Facilities Operations, Plant/Facilities/Utilities Engineering, Reliability Engineering, Maintenance, Calibration, Automation, EHS, Procurement / Purchasing, Equipment Vendors, Architectural / Engineering Services Companies, (Sub-) Contractors, Consultants

Innovation:

Generate innovative solutions to highly complex problems

Demonstrated problem solving skills to support resolution of Engineering, Manufacturing and/or Quality-related issues

Complexity:

Assess, analyze, advise, propose and direct improvements that will deliver greater productivity, capacity, reliability and compliance for the Process Engineering Department

Ensure compliance to all regulatory GMP, Safety and Environmental requirements

Shall interface with regulatory agency representative (e.g. FDA/EMA) as the site Process Engineering SME during internal and external audits and shall be able to defend current practices to such agencies

Strong skills to work in matrix organization with excellent interpersonal, communication, influencing, and negotiation skills required
雇用形態 正社員
応募資格 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

Leader of CAPEX project delivery and equipment acquisition processes

Mentor in applying process improvement methodologies such as DMAIC and Root Cause Analysis (RCA), and tools such as Failure Mode and Effects Analysis (FMEA)

Understanding of Good Manufacturing Practices (GMP)

Experience with leading expert for e.g statistical data analysts and data visualization tools

Experience in managing of all machines/lines/systems and all its components

SME of Process Unit Operations in Pharmaceutical Manufacturing

Expert of CAPEX project delivery and equipment acquisition processes

Fluency in English

Fluency in Japanese is preferred
英語力 ネイティブレベル
年収 1300万 〜 1700万円
給与詳細 ■給与: 経験・スキルに応じ当社規定により決定します
基本給 月¥649,800~
*残業手当は残業時間に応じて別途支給
諸手当:通勤手当、住宅手当、残業手当等
昇給:毎年
賞与支給:年2回
想定年収 1300万円-1700万円
勤務地 大阪府
備考 ”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us.
global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

企業情報

匿名

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