Job Description
As a Calibration Maintenance Technician, you will be the subject matter expert in our Sterile Fill Finish maintenance operation and recognized as an industry expert.
Position Summary
The person must ensure equipment is maintained in a validated state meeting cGMP requirements. Developing, deploying, and improving validated processes are key to ensuring maximum levels of performance and compliance.
Responsibilities:
* Understand in detail how the equipment operates, with a particular focus on instrumentation and calibrations.
* Work closely with the manufacturing team to coordinate and carry out planned and reactive maintenance with minimal disruption to production and program 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 improvement of equipment performance.
* Lead and support the implementation of a Computerized Maintenance Management System (CMMS) 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 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, SOPs, and regulatory guidelines.
* Take ownership of quality compliance in all activities you are responsible for.
Qualifications and Skills Required:
1. Senior trade and/or relevant third-level qualification in Instrumentation, Electrical, or Multiskilled discipline.
2. Minimum 5-10 years' calibration maintenance experience within a relevant environment (preferably within a Pharma manufacturing environment).
3. Experience in a sterile Manufacturing environment would be an advantage.
4. Safety and cGxP compliance.
5. Ability to understand engineering processes through a logical, data-driven approach.
6. Technically highly skilled in hands-on Maintenance and has strong attention to detail.
7. Multi-skilled - Primarily Calibration & Metrology, but an understanding of Electrical & Automation would be a distinct advantage.
8. Methodical problem-solving approach.
9. Operate SCADA/control systems and retrieve/interpret data.
10. Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective.
11. Proven track record of building relations with equipment vendors.
12. Proficient in Microsoft Office.
13. Professional, proactive demeanor.
14. Strong interpersonal skills.
15. Excellent written and verbal communication skills.
Morgan McKinley is working in partnership with Horizon Therapeutics.