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Lead a cross-functional team during technical transfers (sending site) and new product introduction (NPI) (receiving site) projects in accordance with a pre-approved project plan, schedule and current project management best practice. Ensure that critical manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements as needed. Liaise with technology transfer project counterparts in other Takeda sites;

Project manage the technical transfers to ensure a smooth transition;

Execute early stage feasibility, technical, process optimisation and process validation studies;

Liaise with the Engineering Process Support Team to identify process improvement opportunities for legacy products. Propose and implement sustainable solutions to reduce processing times, improve yield, reduce defects and eliminate waste;

Identify cost-effective opportunities for the introduction of best-in-class manufacturing technologies. Design and introduce these technologies to manufacturing operations;

Review Change Records and Risk Assessments to assess potential process and validation impact;

Use statistical software packages for data analysis and in the identification and reporting of shifts, signals and trends in process parameters and product quality attributes;

Execute process improvement projects and deviation investigations using Six Sigma methodologies;

Liaise with other departments, vendors, external consultants & other Takeda sites as required;

Provide regular progress updates (written and verbal) on projects and activities within and beyond the Manufacturing Sciences Team as stated in project communication plans and/or as required by the relevant stakeholders;

Adhere to the compliance matrix of business processes and routine departmental tasks;

Comply with the relevant industry and Company quality standards and the cGMP pertaining to pharmaceutical production;

May be required to assume responsibilities of Process Support Engineer where applicable, from time to time and as directed by the Manager or Director.

General Responsibilities

Participate fully in any cross functional training initiatives;

Drive and promote the corporate values of company within the workplace;

Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business;

Ensure timely completion of all SOP reading, training and assessment;

Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

Requirements

Degree qualified in a Science or Engineering discipline;

Masters in a related field is preferable.

Relevant Experience/Competencies

Ideally 3 - 5 years’ experience as a Process Engineer with Pharmaceutical industry and New Product Introduction project experience;

Operations, process / technical support, projects or validation-based experience of oral solid dosage manufacturing processes an advantage;

Experience with technical transfers (sending site) for pharmaceutical products an advantage.

Excellent communication, report writing, presentation, interpersonal and time management skills.

Qualifications

Bachelors Degree in Engineering

Skills

Experience

3-5 years

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