Manufacturing Science Process, Associate Director

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

職務内容 医療用医薬品やワクチン等の製造設備について以下の業務に従事いただきます。 工場全体の設備・機器・計装の校正の実施 設備・機器・計装の校正の実施に責任を持ち、規格通りに製品が製造されることを保証する メンテナンス部門、製造部門等と協同し、最適な校正の実施 校正記録のシステム管理(CMMS: Computerized Maintenance Management Systems) 校正業務の継続的な見直し

職務範囲 設備保全業務に関する計画立案、予算算出、計画保全の実施、トラブル対応、保全実施取引先の工事監理 設備の改造・更新工事の計画、予算算出、設計・工事監理、試運転、バリデーション GMPに関する技術情報管理、新技術評価 SAPを利用した保全業務の指図作成、見積、保全実施、検収の一連の業務の遂行 グローバルSOPとの整合を含むメンテナンス関係のSOPの維持・管理 上記職務をグローバルネットワークの中で推進していくとともに、ハンズオンで改善・改革をリードしていくマインドやスキルが求められます。

【職務内容】 工場の新設工事ならびに改良工事における、洗浄バリデーション業務を実行します。 ・医薬品製造設備の洗浄プロセスを評価し、バリデートする責任を負います。 ・主な業務には、プロトコール作成、バリデーション作業の調整、バリデーションの実施、最終報告書の作成、最終バリデーションパッケージの作成、プロジェクト計画の作成が含まれます。 ・イニシャルバリデーションと再バリデーションの両方の責任を有します。さらに、製造上の課題の調査を行い、プロセスの改善を評価し、報告文書を作成します。 ・規制当局への文書提出、またはそれをサポートし、内部および外部の査察の際、必要に応じて利用できるように保管・管理します。 上記の業務を製造部門、エンジニアリング部門、薬事部門、品質管理部門、品質保証部門と日々連携して業務を行います。