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.At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.Our expertise, science and technology make us a pharma company.
Our open and progressive culture is what makes us Astellas.
It's a culture of doing good for others and contributing to a sustainable society.Delivering meaningful differences for patients is our driving force.
We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.
At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action.
We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.