Process Development Student

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Job Description

JOB DESCRIPTION

JOB TITLE:       Process Development Student

REPORTS TO:  Process Development Engineer, Manufacturing Sciences Dept

JOB PURPOSE:

The intern will gain experience in the pharmaceutical manufacturing industry within the Manufacturing Sciences Group.

RESPONSIBILITIES:

• Collaborate with the process engineers and compliance engineers on new product introduction (NPI) and process improvement projects;
• Use statistical software packages in the identification and reporting of shifts, signals and trends in critical process parameters and product quality attributes;
• Conduct production-based trials and studies, including in-process testing of product and creation of associated reports;
• Creation of standard procedures for continuous improvement including non-value adding (NVA) analysis and redesign of existing standard Manufacturing Sciences procedures;
• Preparation, review and/or execution of Risk Assessments, GMP assessments, Manufacturing Instructions, Annual Product Reviews and Validation Protocols / Reports;
• Contribute to Technical Studies, Optimisation Studies, Process, Hold Time and Cleaning Validations;
• Management of internal systems: requalification’s, periodic reviews, sample orders, trial material, process recipes, Investigation & Test Plans, 5S, product sample management and Change Records;
• This position presents an exciting opportunity to work in cross functional teams with departments such as Production, Packaging, Engineering, Quality Assurance, Quality Control, Agile and Supply Chain.

GENERAL RESPONSIBILITIES:

• Participate fully in any cross functional training initiatives;
• Drive and promote the corporate values of Takeda-ism 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 training and assessment;
• Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS: 

• Studying towards third Level Qualification in Engineering or Science.

RELEVANT EXPERIENCE:

• Knowledge of the pharmaceutical industry and pharmaceutical Oral Solid Dosage(OSD) would be preferable but not essential.

SKILLS/COMPETENCIES:

• A self starter with initiative and good interpersonal skills is required;
• The applicant should also have excellent communication, report writing, time management skills and be highly IT proficient;
• Attention to detail is also required to comply with the relevant industry and Company quality standards and the cGMP rules pertaining to production.

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