P2 API Plant Technologist

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Job Description

P2 API Plant Technologist - Fixed Term Contract

Fixed Term Contract

Location: Grange Castle

About the role:

• Support the P2 (Plant 2) operational readiness team in the introduction of Takeda product manufacturing to Grange Castle.
• Complete manufacturing activities promptly and to the highest quality to ensure relevant site goals are achieved.
• Work as part of the P2 team to ensure all start-up and manufacturing relating activities are performed 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 tasks as directed in whatever area of manufacturing operations they are assigned. This would include (but not be limited to) batch processing, utility monitoring and waste management.
• Help develop Standard Operating Procedures (SOPs) and Equipment Operating Procedures (EOPs) for P2 operations.
• Accomplish 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.
• Participate in AGILE at TILGC including problem identification, Just do its, Root Cause Analysis (RCA) and Agile Projects.
• 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 a thoughtful according to the relevant documentation.
• Ensure that the workplace and ancillary facilities are maintained in a clean and tidy state and during manufacturing activities.
• Ensure that housekeeping tasks 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.
• Accomplish minor repairs/adjustments to plant and ancillary equipment and as authorised.
• This role may involve shift work to meet future production demands.

Environmental, Health & Safety

• Foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business.
• Follow all safety policies, procedures and regulations.
• Notify the P2 API team lead (or other appropriate responsible person) 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 / Beacon reports are completed promptly 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

• Participate in auditing programmes but concerning contracted engineering and related services.
• Notify the Manufacturing Operations Manager/Designee (or other appropriate responsible person) of any deviations from defined manufacturing processes or other established procedures. Any abnormal occurrences or observations should also be reported.
• Produce documentation associated with their activities by cGMP, Health and Safety and Environmental regulations or management systems.
• Ask, if in doubt, about any practice or unusual finding.

Training

• Participate in all training and assessment activities (internal and external) concerning themselves, contractors or other employees.
• Preparation and delivery of training materials.
• Ensure completion of all SOP reading, training and assessment tasks.
• Ensure that all training and assessment is promptly recorded for themselves and other relevant personnel following TILGC procedures.

General Responsibilities:

• Participate in any training plans.
• Promote the core values of Takeda.
• Promote a culture of continuous improvement through all areas of the business
• Foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business.
• Other responsibilities 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.
• 5+ years of experience in a high potency API manufacturing facility.
• 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.
• Safety Focused.
• Excellent planning, scheduling and prioritisation ability.
• Excellent documentation skills.
• Excellent PC and systems skills.
• Experience with Automation Production Systems e.g. MES

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 programmes including onsite flu shots and health screenings

Educational Assistance

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programmes. 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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