Job Summary
- Waterford
- Permanent
- 2212
- Aug 15, 2023
- Competitive
Job Description
As a Maintenance Technician, you'll play an important role in being the subject matter expert in our Sterile Fill Finish maintenance operation and be a recognized expert in this industry.
As a Maintenance Technician, you'll play an important role in being the subject matter expert in our Sterile Fill Finish maintenance operation and be a recognized expert in this industry. You will also have responsibilities to maintain equipment/systems in non-Sterile and non-GMP areas that are critical to the manufacturing process.
Position Summary:
The person needs to also ensure equipment is maintained in a validated state meeting cGMP requirements. Development, deployment and improvement of validation 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.
- Support the Operations Team in the reliable operation of their equipment.
- Carry out planned and reactive Maintenance as required.
- Develop Maintenance SOPs, WIs and PMs.
- Develop Maintenance schedules and ensure PMs and calibrations are completed per schedule.
- Ensure spare parts requirements are available and cost-effective for equipment.
- Effective problem-solving and reactive maintenance as required.
- Ensure the preventative maintenance routines are executed on time and in a compliant manner.
- Continuously improve the process through the improvement of equipment performance.
- Support the implementation of a Computerized Maintenance Management System.
- 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.
- Minimum 5-10 years' maintenance experience within a relevant environment (preferably within a Pharma manufacturing environment).
- Experience in a sterile Manufacturing environment is a strong preference.
- Experience in drafting SOPs, WIs and PMs would be an advantage.
- Safety and cGMP compliance.
- Ability to understand engineering processes through a logical, data-driven approach.
- Technically, highly skilled in hands-on Maintenance.
- Attention to detail.
- Multi-skilled - Primarily Electrical, but an understanding of Calibration and Instrumentation is also desired. Basic mechanical knowledge would be an advantage also.
- 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.
- Professional, proactive demeanor.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.
Morgan McKinley are working in partnership with Horizon Therapeutics