Maintenance Technician

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