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P2 Plant Technologist

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Job ID R0040912 Date posted Aug. 19, 2021 Location Dublin, Ireland

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Job Description

JOB PURPOSE:

Reporting to the P2 Drug Product Team Lead the P2 Plant Technologist will:

  • Work as part of the team to ensure all manufacturing relating activities are executed to ensure operational targets are achieved.
  • Adopt and follow all EHS and quality procedures in their daily activities.

RESPONSIBILITIES:

  • Work to ensure your team give the best of themselves in order to achieve the company and departmental goals.
  • Carry out and monitor manufacturing operations in strict compliance with, the relevant manual or electronic manufacturing instruction (BMR / EBR) 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
  • The 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 DP 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.
  • Participate as a member of the site Emergency Response Team if required.
  • Manage waste streams resulting from the manufacturing process and dispose of waste according to onsite waste management procedures.

Quality Systems and GMP

  • Proactively participate in auditing programmes as required but particularly in relation to contracted engineering and related services.
  • Notify the P2 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.

Training

  • Actively participate in all training and assessment activities (internal and external) in relation to themselves, contractors or other employees.
  • 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.

EDUCATIONAL REQUIREMENTS: 

  • Leaving Certificate or equivalent,
  • 3rd level technical qualification in science or engineering discipline (is an advantage)

RELEVANT EXPERIENCE:

  • Experience in Solid Oral Dose Production, preferably Capsule filling and/or Primary Packaging
  • Experience in a high potent manufacturing facility would be an advantage.
  • Start-up experience of a pharmaceutical production facility would be an advantage.

SKILLS/COMPETENCIES:

  • Flexible, willing and positive attitude / mindset.
  • Safety Focused.
  • Excellent verbal and written communication skills.
  • Excellent planning, scheduling and prioritization 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.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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