Job Title: Operations Technician
Location: Athlone, Ireland
Department: Operations
Reports To: Senior Manager, Manufacturing
Job Type: Full-Time
Work Location Type: On-Site
Travel Requirement: Less than 10% (International)
Job Level: Analyst
Date Revised: 25 April 2025
Position Overview
This role is integral to the success of the manufacturing facility, operating within a cross-functional operations team. The Operations Technician supports routine commercial manufacturing activities while ensuring compliance with regulatory standards. Flexibility, diligence, and a comprehensive approach to both operational and technical responsibilities are essential for this position.
Key Responsibilities
* Develop and update Standard Operating Procedures (SOPs) and Batch Manufacturing Records.
* Assist in creating maintenance and calibration routines to ensure equipment operates per manufacturer specifications.
* Perform preventive maintenance and calibration on manufacturing and utility equipment as outlined in maintenance procedures.
* Execute manufacturing, filling, and packaging processes as required.
* Accurately complete Batch Records, ensuring first-time-right documentation.
* Maintain precise records of calibrations, maintenance, and preventive maintenance activities.
* Adhere to production and maintenance schedules diligently.
* Engage in ongoing training to enhance technical skills.
* Collaborate with Quality Control and Quality Assurance teams to ensure all operations comply with Good Manufacturing Practice (GMP) standards.
* Lead training initiatives for Operations Technicians and Manufacturing Associates on equipment setup and operation.
* Actively participate in continuous improvement efforts.
* Support the receipt, sampling, and secure storage of materials from suppliers.
* Assist in the shipment of products to various distributors.
* Report to and follow directives from the area manager.
Required Knowledge, Skills, and Abilities
* Comprehensive understanding of Environmental, Health & Safety (EHS) requirements.
* In-depth knowledge of Quality System requirements.
* Experience in pharmaceutical manufacturing, including liquid and solid oral dosage forms, as well as filling and packaging processes.
* Proficiency in maintaining cleanroom conditions.
* Strong technical skills, including the ability to troubleshoot equipment issues.
* Demonstrated ability to establish collaborative working relationships across all levels.
* Capability to develop and implement maintenance and calibration routines.
* Accuracy in completing records related to manufacturing, calibration, and maintenance activities.
* Commitment to fostering a culture of change, innovation, and continuous improvement.
* Familiarity with systems such as Laboratory Information Management Systems (LIMS), Maximo/Computerized Maintenance Management Systems (CMMS), Serialization, SCADA Systems, Programmable Logic Controllers (PLCs), and SAP is advantageous.
Education and Qualifications
* Qualified trade certification as an electrician or toolmaker; other relevant qualifications or experience will be considered.
* A third-level qualification in engineering or a science-related discipline is highly regarded.
* Proficiency in Microsoft Word and Excel is required.
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