SK pharmteco, part of SK Inc, is a global Contract Development and Manufacturing organisation (CDMO) with state-of the-art small molecule manufacturing facilities in Korea, US, and Ireland. The SK Small Molecule Europe facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce, exceptional technical capabilities and facilities we make some of the world’s most important medicines. Further information on SK pharmteco can be found at www.skpharmteco.com
Current Need
A vacancy now exists for an E&I Maintenance Specialist within the Operations Department. This is a day role reporting to the Senior Maintenance Specialist. The role provides technical expertise in maintaining and improving the site maintenance and engineering activities in order to ensure minimum downtime and reduction of risks to equipment and production, ensuring we are operating a safe and compliant site.
Responsibilities
Manage OperationsSME for assigned area. Technical person responsible for resolution of long‑term issues and the reliability strategy related to the area of responsibility.Ensure that maintenance routines, calibration procedures, and work plans are developed to the necessary standards for best practice and to ensure compliance with GMP and SHE regulations.Review of planned work schedules to optimize equipment availability and drive improvements in relation to equipment reliability.Champion the use of OPEX tools in relation to equipment reliability.Responsible for leading FMEA activities where required on site to develop appropriate maintenance programs for equipment.Review and approve maintenance records (i.e. work orders, calibrations, and test certs) post work completion. Assist with feedback of compliance and related issues to relevant supervisors.Identify possibilities of incremental improvements with regard to quality of data in work orders and assist supervisors to drive improvements in this data.Project support (capital or expense). Support to be provided in the planned structured environment.Responsible for raising change controls where required and also execution of assigned actions in a timely manner to support change activities on site.Audit support, provide support as required for both internal and external SHE and Quality audits.Maintain links with relevant external organisations (HSA, OSHAS, MEETA etc.) and identify opportunities for knowledge sharing.Participate in department teams, cross functional teams, programs or company initiatives as required.
SafetyLead and assist in Safety and Environmental investigations where required (relating to area of responsibility), including raising accepting CAPA’s and closeout maintenance related CAPA’s.
QualityEnsure all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirements.Lead and assist in GMP Deviation investigations where required (relating to area of responsibility) including raising and accepting CAPA’s, and close out of Maintenance related CAPA’s.
Manage informationContinuous monitoring of equipment performance through the CMMS utilizing all available means to identify equipment failure trends, bad actors and areas which require focus. Develop and execute data driven improvement initiatives.Support the Maintenance manager in the generation and review of performance metrics relating to maintenance activities.
Manage PeopleManage service contract with third party vendors where applicable for relevant equipment. Establish economic and efficient work relationships.Ensure that the standard of maintenance work execution is consistent by developing and/or delivering training as necessary.Facilitate the development of technicians through training and coaching.
Manage FinanceMRO- ensure all purchasing is completed via the CMMS to accurately capture costs and facilitate asset lifecycle cost analysis.Optimise and develop the spare parts and MRO inventory holding related to the area of responsibility.Budgeting and planning support- providing forecast of maintenance work requirements. Monitors spend v budget relating to contracts, shutdown and project plans.
TeamworkWork and liaise with all other maintenance personnel and site automation to achieve common goals and objectives. Work across departments when required. Respect the views of other team members at all times. Promote an open forum for the sharing of ideas to resolve issues. Instruct and assign work for maintenance technicians, liaise with maintenance supervisor to resolve any issues that arise. Liaise with maintenance manager when required.
Environmental and EnergyPartake in energy and environmental management systems as required including awareness training and campaigns, consideration of energy usage/efficiency and potential environmental impact where relevant during day‑to‑day activities.
DevelopmentKeep self‑up to date with changes in legislation and improve work practices. Ensure that training is attended both internal and external to continually update toolset.
HousekeepingAfter all work is completed clean all work areas and ensure that area is production ready and safe to work in. If working in conjunction with contractors, ensure that they follow SK Biotek Ireland protocols at all times regarding housekeeping.
Required Key Skills and Experience
Relevant engineering qualification or trade background
Cross skilling ability and training.
Calibration management experience.
Pharmaceutical experience desirable
Operation of a CMMS in a regulated environment.
Other Benefits
Excellent opportunities for career enhancement and personal development.
Competitive base salary.
Annual bonus linked to business results.
A well‑established further education program.
Pension scheme.
Private healthcare.
SK pharmteco SM Europe is an equal opportunity employer
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