Astellas Pharma Inc.

Process Operator

Building your career at Astellas continues to offer inspiring challenges and a chance to make your mark in doing good for others.

Our open and progressive culture is what makes us Astellas. It is a culture of doing good for others and contributing to a sustainable society.

Reporting to the Production Team Leader, the Process Operator will be responsible for the execution of assigned duties in line with site policies and procedures, as well as site safety, environmental and operational standards. The chosen candidate will also be responsible for the delivery of the function’s objectives in support of the site’s goals and strategic objectives, including support of area projects. Also actively participate in the sites Operational Excellence Programme and to fully contribute to its application in the Production area.

About This Job

• Ensure compliance of manufacturing operations with relevant regulations and standards associated with cGMP including data integrity, ISO 45001, ISO 14001, Health & Safety Legislation and Environmental Legislation.  
• Timely and comprehensive reporting of all hazardous occurrences, incidents, deviations & abnormal occurrences.
• Ensure compliance of manufacturing operations with all site standards, policies, and procedures.  Knowledge of these standards must be kept up to date using site training programs.
• Ensure that the production plants are operated to optimum efficiency.
• Provide input and support for continuous improvement initiatives in Manufacturing and other areas as required, includes identifying opportunity for improvements in efficiencies, operations, and procedures.
• Closely monitor the operation of the plant and process both in the field and from the plant control systems to ensure compliance with process requirements.  
• Perform all activities/operations as required and defined in the relevant documentation (e.g., SOPs, MIR).
• Prepare ingredients and processing requirements for batches and load prescribed quantities to batches.
• Take and deliver samples to the laboratory. 
• Clear blockages.
• Complete inline filter change outs where required or as directed by the Production Team Leader P3 / Senior Process Operator P3.
• Clean the plant area and process ancillary equipment, maintaining general housekeeping at a high level.
• Calibrate Manufacturing instruments in line with current procedures and as directed by the Production Team Leader P3 / Senior Process Operator P3.
• Actively participate in training programmes and continuous improvement or other initiatives as directed by the Team Leader.
• Carry out minor repairs/adjustments to plant and ancillary equipment where possible and as authorised.
• Operation of fork truck or other materials handling equipment as required.
• Perform the required duties of other areas assigned to (provided you are trained to do so) such as Warehouse & Materials Management, Environment & Utilities.
• Participate in the preparation and update of Manufacturing SOPs or Manufacturing related documentation as directed by the Production Team Leader P3.
• Support inter manufacturing campaign cleaning and product changeovers including the completion of all associated tasks as set out in the CIR (This will include confined space vessel entries as required).
• Ensure daily scheduled activities are complete, this may require unforeseen flexibility around the site core business hours.  Batches must be progressed to a safe holding point before activities are concluded.
• Support and cooperate with other departments to maintain site goals and KPI’s.
• Other issues as directed by the Production Team Leader P3 / Senior Process Operator P3.

Essential Knowledge & Experience

• Leaving Certificate or equivalent.

• Previous experience in a similar role or possess transferable skills related to the role.
• This position is based in P3 Dublin Plant and will require on-site work circa 40hrs per week. In addition, the candidate must be willing to work additional hours and/or travel as required by the business.
• Shift work may be required in the future depending on site demands.
• The position involves working directly with the Production operations team and in close collaboration with EHS and other site functions connected with the assigned duties.