P2 Plant Technologist - Grange Castle

Job Description

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Job Description

About the role:

Reporting to the P2 API Team Lead the P2 Plant Technologist will:

• Work as part of the P2 operational readiness team to support the introduction of Ninlaro manufacturing to Grange Castle.
• Work as part of the P2 team to ensure all start-up and manufacturing relating activities are executed to ensure operational targets are achieved.
• Adopt and follow all EHS and quality procedures in their daily activities.

Fully onsite work mode.

How you will contribute:

• Perform duties as directed in whatever area of manufacturing operations they are currently assigned. This would include (but not be limited to) batch processing, utility monitoring and waste management.
• Assist in the development of Standard Operating Procedures (SOPs) and Equipment Operating Procedures (EOPs) for P2 / Ninlaro operations.
• Assist in Site Acceptance Testing (SAT) and qualification of new equipment as required.
• Carry out and monitor manufacturing operations (including all control system activities) as directed by, and in strict compliance with, the relevant manual or electronic Batch Manufacturing Instruction and Record (BMR) and Standard Operating Procedures (SOPs) or other Protocol.
• Actively participate in AGILE at TILGC including problem identification, Just do its, Root Cause Analysis (RCA) and Agile Projects.
• Actively support and contribute to the introduction of new processes and the execution of process validation by and under the direction of relevant support personnel.
• Ensure that the manufacturing and ancillary facilities are operated to optimum efficiency.
• Ensure that changeovers of both equipment and production areas are carried out in an efficient and effective manner.
• Ensure that the workplace and ancillary facilities are maintained in a clean and tidy state at all times and particularly during manufacturing activities.
• Ensure that housekeeping duties are completed as assigned including the physical cleaning of process and ancillary facilities
• Take and deliver samples to the laboratory; complete any in-process testing assigned to them.
• Carry out minor repairs/adjustments to plant and ancillary equipment where possible and as authorised.
• This role may involve shift work as required to meet future production demands.

Environmental, Health & 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 P2 API team lead (or other appropriate responsible person) in a timely and comprehensive manner of any:
• Breach of HSE policy, procedure or regulation.
• Potential hazard which could have a serious impact on safety or result in serious injury.
• Ensure that Unplanned Event Forms are completed in a timely manner after an event.
• Participate as a member of the site Emergency Response Team.
• Manage waste streams resulting from the manufacturing process and dispose of waste according to onsite waste management procedures.

Quality Systems and GMP

• Preparation of reports in relation to deviations and/or investigations, as required.
• Proactively participate in auditing programmes as required but particularly in relation to contracted engineering and related services.
• Notify the Manufacturing Operations 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 reported.
• Generate documentation associated with their activities as required by cGMP, Health and Safety and Environmental regulations or management systems.
• Ask, if in doubt, about any particular practice or unusual finding.

Training

• Ensure that staff are well trained to safely and effectively carry out their roles. Develop training for relevant personnel with a particular focus on direct operational and technical support personnel.
• Actively participate in all training and assessment activities (internal and external) in relation to themselves, contractors or other employees.
• Preparation and delivery of training materials.
• Ensure timely completion of all SOP reading, 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.

General Responsibilities:

• Participate fully in any cross functional training initiatives.
• Promote the corporate values of Vision 2025 and Takeda-ism within the workplace.
• Drive and promote a culture of continuous improvement through all areas of the business
• 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.
• Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

What you bring to Takeda:

• Leaving Certificate or equivalent,
• Degree or 3rd level technical qualification in science, chemistry or equivalent. (is an advantage)
• Experience in a high potency API manufacturing facility would be an advantage.
• Experience handling and working with hazardous chemicals would be essential.
• Experience with automation control systems, SCADA would be preferable.
• Proficient in the use of MES systems.
• Start-up experience of a pharmaceutical production facility would be an advantage.
• Flexible, willing and positive attitude / mindset.
• Safety Focused.
• Excellent verbal and written communication skills.
• Excellent planning, scheduling and prioritisation ability.
• Excellent documentation skills and attention to detail.
• Excellent PC and systems skills.
• Experience with Automation Production Systems e.g. MES
• Attention to detail is critical.
• Strong Quality orientation.

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewellery, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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