Process Development Engineer Student - Grange Castle

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Process Development Engineer Student - Grange Castle

Dublin, Ireland

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On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
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Process Development Engineer Student - Grange Castle

Job ID R0082378 Date posted Nov. 22, 2022 Location Dublin, Ireland

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Job Description

JOB PURPOSE:

A Process Development Engineer has a very important role to play in TILGC’s commitment to quality and efficient manufacturing together with the training of people. Specific and varying duties will be given to a Process Development Engineer in relation to their current assignment but some key tasks and responsibilities are outlined below.  A Process Development Engineer must be capable of working both on their own initiative and as part of a very flexible team in a demanding, regulated environment.  They are required to proactively contribute to the delivery of manufacturing targets in compliance with quality, safety and environmental requirements and on schedule.

The role of Student Engineer is a learning and development internship as a Process Development Engineer. The role is aimed at developing or demonstrating the skills and responsibilities outlined below in preparation for the employee’s future career.

RESPONSIBILITIES:

Operations

  • Perform duties as directed in whatever area of manufacturing operations they are currently assigned to.  This would include (but not be limited to) :

- the provision of direct technical support to manufacturing operations (both  troubleshooting and on an ongoing basis)

-  investigation and reporting in relation to equipment and processing issues
-  technology transfer and associated support both to and from the TILGC site
-  hazard evaluation and control including HAZOPs and Process Reaction Safety analysis

-  the specification, selection and introduction of new equipment

  • Play a leadership role in the introduction of new processes together with the preparation and execution of process validation programs.
  • Provide technical support and direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency and that changeover of both equipment and production areas can be carried out in an efficient and effective manner.
  • Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services.  Continuous improvement with a cross functional focus is a core activity.
  • Carry out any manufacturing activities, as required, in strict compliance with the relevant Batch Manufacturing Instruction and Record (BMR) and Standard Operating Procedures (SOPs) or other Protocol.
  • Quality Systems and GMP
  • Perform development and manufacturing operations in accordance with TILGC quality standards, current Good Manufacturing Practices (cGMP) and all other relevant policies, procedures, regulations and standards including and Environmental, Health & Safety(EHS) Legislation.
  • Complete required documentation relating to development and manufacturing activities in an accurate and timely manner. Such documentation would include (but not be limited to) BMRs, records required by SOPs, Logbooks and Labels as well as EHS records.
  • Notify the Process Development Manager/Designee (or other appropriate responsible person) in a timely and comprehensive manner of any deviations from defined manufacturing processes or other established procedures.  Any abnormal occurrences or observations should also be so reported.
  • Generate documentation associated with their activities as required by cGMP and review Standard Operating Procedures (SOPs), Batch Manufacturing Instruction and Record (BMRs), Logbooks, Labels, In-Process Test documentation, and other regulatory documentation (Quality, Environmental, Health & Safety,) as required.
  • Assist the Plant Team Leader with the review of batch documentation, as required.
  • Ask, if in doubt, about any particular practice or unusual finding.

Safety

  • Actively foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
  • Adhere fully to all safety policies, procedures and regulations.
  • Notify the Process Development Manager/Designee (or other appropriate responsible person) in a timely and comprehensive manner of any
    - breach of EHS policy, procedure or regulation.

- Potential hazard which could have a serious impact on safety or result in serious personal injury.

  • Complete Accident Reports / Near Miss Forms in a timely manner after an event.

Housekeeping

  • Maintain the workplace and ancillary facilities in a clean and tidy state at all times and particularly during manufacturing activities.

Training

  • Lead/actively participate in all training and assessment activities (internal and external) in relation to themselves, manufacturing personnel or other employees.
  • Preparation and delivery of training materials.
  • Ensure timely completion of all SOP training and assessment tasks.
  • Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures. 
  • Maintain and improve their professional knowledge base.  Keep up to date with all current trends and relevant legislation.

EDUCATIONAL REQUIREMENTS:     

  • Studying towards 3rd Level Degree in  Science/ Engineering or other relevant course

RELEVANT EXPERIENCE/CRITERIA:

  • Good organisational, communication, interpersonal and report writing skills.
  • Good computer skills
  • Ability to adapt to changing priorities.
  • Ability to work as part of a team.
  • A self-starter with initiative and good interpersonal and analytical skills is required

To be eligible for the this role you must be currently undergoing an undergraduate degree.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Paid Intern (Fixed Term) (Trainee)

Time Type

Full time

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