Description

Purpose

Drive the ambition for patients by ensuring plant change overs between different products or stages in Jurong site manufacturing are carried out with optimum efficiency to maximize plant availability within the framework of current Good Manufacturing Practices (cGMP), quality, safety, responsible environmental protection and in cognizance of the dynamic business environment.

Overseeing and managing change over activities for PB1/2/3, this role will ensure the successful plant turnaround end-to-end between products or stages. Driving the change over as a value stream, the role is responsible for the planning & scheduling including resource management of the various activities ranging from cleaning down of the plant, configuration of the plant for next process and starting up of the plant for manufacture to ensure a seamless flow. This will also include close collaboration and alignment support from other key functions e.g., engineering and quality etc. on related activities for the plant change over not limiting to maintenance work, instrument calibration prior campaign, necessary testing and plant inspection.

This role will also review the efficiency and effectiveness of the change over as a value stream and is responsible to improve the change over duration and cost to support the site ambition to drive flow in manufacturing and improve the average stock turn year on year and reduce the change over cost. Perform data analysis on process waste, in manpower and machine deployment efficiency and effectiveness, the method used and the correct measurements, propose and implement changes to reduce the identified waste to achieve excellent time and cost efficiency and effectiveness in the cleaning activities.

This role is also accountable for setting the plant change over strategy for the Jurong site, including the development and delivery of

the Cleaning Validation Master Plan (CVMP). The role will review and amendment of cleaning plans to maximise cleaning efficiency and minimise

cleaning days. As a subject matter expert for all cleaning activities, this role will prepare and lead the site during internal and external audits with

regards to all cleaning related activity and be the site representative in the Cleaning Lifecycle Management Community of Practice (CoP) where the

topics on validation approach and improvement to the cleaning approach are agreed. This role will serve to influence, agree and adopt and share good

practices on an effective cleaning approach in the CoP.

Responsibilities

• Drive the plant change over activities end-to-end between products or stages to ensure the plant meet required criteria (e.g. cleanliness requirements, plant appropriately configured etc.) for manufacture within the stipulated timelines, cost, sustainability expectations and in full compliance with the relevant safety and quality requirements, regulations standards.
• Driving the change over as a value stream with required planning & scheduling including resource management of the various activities ranging from cleaning down of the plant, configuration of the plant for next process and starting up of the plant for manufacture. This will also include securing and aligning the support from other functions e.g., engineering and quality etc. on related activities for the plant changeover not limiting to maintenance work, instrument calibration prior campaign, necessary testing and plant inspection.
• Managing a team and drive performance management with necessary establishment of tier reviews including visuals & metrics to track progress including escalation process and problem solving.
• Lead the team in troubleshooting all plant turnaround related issue and ensure root caused is determined with CAPA in place.
• Develop, review and approve all relevant documents relating to Change Over in accordance to site procedures.
• As a subject matter expert for all cleaning activities, prepare and lead the site during internal and external audits with regards to all cleaning related activity.
• Act as a subject matter expert for cleaning validation at Jurong, develop and implement the CVMP, cleaning validation documentation and strategy, ensuring the correct application of the validation quality systems is in line with regulatory standards and be a strong advocate for validation approaches and activities during internal and external audits. This will also include working with necessary stakeholders in establishing the cleaning approach for New Chemical Entities (NCEs) introduced to the site.
• Apply good project management skills and liaise with the first touch functions including MSAT, Engineering & Quality to resolve technical issues in relation to implementation of cleaning activities, adequate management of cleaning activities and validation, adequate resources in production team, engineering services, laboratory and quality & support the change control process.
• Generate operational expenditure (OPEX) pertaining to Change Over for budgeting with proactive tracking and managing on spend.
• Continuously optimize the cleaning processes to maximise cleaning efficiency, duration required and reduce cost of each change over through by working with various parties (MSAT, DDA, quality and engineering):
• Using GPS methodology and Operation Excellence methodology by implementing standard work and visual controls with the right leading ad lagging time element measurement and data collection KPIs.
• Applying Digital Data Analytics (DDA) and implement technologies to enhance and transform plant change over
• Ensure that all change over materials and all solvents are accounted for during the issue of a change over batch sheet, so that the SAP system will ensure they are present when required. Accountable for accuracy of Bill of Materials (BOMs) related to change overs as required, to ensure they are accurate.
• Consider and influence product scheduling, sequencing and campaign length at a higher level to ensure the most efficient use of plant vs change over activities and customer demand.
• Manage, develop, and motivate staff to help realize their maximum potential so as to contribute towards achieving the objectives of the department.

Knowledge, Skills & Experience

• A degree in Chemistry or Chemical Engineering or any relevant field.
• For "Lead" position - At least 6-8 years relevant experience in the pharmaceutical, chemical or petrol chemical industry
• For "Manager" position - At least 8-10 years of relevant experience in the
• Good knowledge of production processes and the plant.
• Good working knowledge of cGMP, Health and Safety practices
• Good knowledge of Quality Systems
• Good knowledge of cross-functional business processes – manufacturing, engineering and
• Good project management with ability to communicate at all levels of the organisation.
• Understanding of the budget management, business cost and financial impacts.
• Able to work in a diverse and dynamic environment

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