Job Description
As a Calibration Maintenance Technician, you'll be the subject matter expert in our Sterile Fill Finish maintenance operation and recognized industry expert.
Position Summary:
The role requires ensuring equipment is maintained in a validated state meeting cGMP requirements. Development, deployment, and improvement of validated processes are crucial for maintaining maximum performance and compliance levels.
Responsibilities:
* Understand equipment operations in detail, with a focus on instrumentation and calibrations.
* Work closely with manufacturing teams to coordinate planned and reactive maintenance without disrupting production schedules.
* Coordinate equipment calibration with outside vendors.
* Develop maintenance SOPs, WIs, and PMs.
* Continuously improve calibration procedures.
* Develop maintenance schedules and ensure PMs and calibration routines are completed as per schedule and in a compliant manner.
* Ensure spare parts availability and cost-effectiveness for equipment.
* Effective problem-solving and reactive maintenance as required.
* Improve process performance through equipment optimization.
* Lead and support the implementation of a Computerized Maintenance Management System (CMMS) and ensure high-quality data input for effective performance analysis.
* Investigate and analyze manufacturing and utility system issues.
* Identify and escalate compliance-related issues requiring interventions.
* Operate production equipment in a GMP environment if required.
* Support project activities to ensure maintenance and operational requirements are included.
Health, Safety, and Environment:
* Comply with Health, Safety, and Environmental policy and associated procedures at all times.
* Promote a positive safety culture by challenging yourself and others to prioritize safety in all actions.
Quality Compliance:
* Ensure work complies with required standards, adhering to company, cGMP, cGLP, SOPs, and regulatory guidelines.
* Take ownership of quality compliance in all activities.
Qualifications and Skills Required:
1. Senior trade or relevant third-level qualification in Instrumentation, Electrical, or Multiskilled discipline.
2. Minimum 5-10 years' calibration maintenance experience in a relevant environment (preferably Pharma manufacturing).
3. Experience in sterile manufacturing would be advantageous.
4. Safety and cGxP compliance.
5. Data-driven approach to engineering processes.
6. Highly skilled in hands-on maintenance with strong attention to detail.
7. Multi-skilled - Primarily Calibration & Metrology, but understanding of Electrical & Automation is an advantage.
8. Methodical problem-solving approach.
9. SCADA/control systems operation and data retrieval/interpretation.
10. Audits interaction 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 demeanor.
14. Strong interpersonal skills.
15. Excellent written and verbal communication skills.