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Calibration Maintenance Technician, Waterford
Client:
Morgan McKinley
Location:
Waterford, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
f0851f7c2fbf
Job Views:
90
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
Job Description
As a Calibration Maintenance Technician, you'll play an important role in being the subject matter expert in our Sterile Fill Finish maintenance operation and be a recognised expert in this industry.
Position Summary:
The person must ensure equipment is maintained in a validated state meeting cGMP requirements. Development, deployment, and improvement of validated processes are key to ensuring the maximum levels of performance and compliance are maintained.
Responsibilities:
Maintenance and Operations
* Understand in detail how the equipment operates with a particular focus on instrumentation and calibrations.
* Work very closely with the manufacturing team to coordinate and carry out planned and reactive maintenance with minimal disruption to production and programme schedules.
* Coordinate calibration of equipment with outside service vendors.
* Develop Maintenance SOPs, WIs and PMs.
* Continually improve procedures for calibration.
* Develop Maintenance schedules and ensure PMs and Calibration routines are completed per the schedule and in a compliant manner.
* Ensure spare parts requirements are available and cost-effective for equipment.
* Effective problem-solving and reactive maintenance as required.
* Continuously improve the process through the improvement of equipment performance.
* Lead & Support the implementation of a Computerized Maintenance Management System (PEMAC) and ensure high-quality data input to enable effective performance analysis.
* Leads and supports investigations and Root Cause Analysis of manufacturing and utility system issues.
* Identifies and escalates the need for interventions due to compliance-related issues.
* Operate Production equipment if required in a GMP environment.
* Support Project activities as required to ensure Maintenance and Operational requirements are included. FAT attendance, commissioning and qualification support.
Health, Safety and the Environment
* Comply at all times with the Health, Safety and Environmental policy and associated procedures.
* Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
Quality Compliance
* Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP's and regulatory guidelines.
* Take ownership of quality compliance in all activities you are responsible for.
Qualifications and Skills Required:
* Senior trade and/or a relevant third-level qualification in Instrumentation, Electrical or a Multiskilled discipline.
* Minimum 5-10 years' calibration maintenance experience within a relevant environment (preferably within a Pharma manufacturing environment).
* Experience in a sterile Manufacturing environment would be an advantage.
* Safety and cGxP compliance.
* Ability to understand engineering processes through a logical, data-driven approach.
* Technically, highly skilled in hands-on Maintenance and has strong attention to detail.
* Multi-skilled - Primarily Calibration & Metrology, but an understanding of Electrical & Automation would be a distinct advantage.
* Methodical problem-solving approach.
* Operate SCADA/control systems and retrieve/interpret data.
* Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective.
* Proven track record of building relations with equipment vendors.
* Proficient in Microsoft Office.
* Strong interpersonal skills.
* Excellent written and verbal communication skills.
Morgan McKinley are working in partnership with Horizon Therapeutics
Apply Now
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