- Location: Dundalk, Co. Louth
- Sector: Biologics
- Duration: Permanent
What’s In It For You?
- Recognition And Reward
- Inclusive And Diverse Culture
- Career Development And Progression
- Global Client Projects
- Global Travel Opportunities
- Benefits Especially For You – Pension Contribution, Health Insurance, Maternity/Paternity Leave
- Work With The Most Innovative Technologies
About LotusWorks:
LotusWorks exists to support world-leading organisations with engineering and technical expertise for over 34 years. LotusWorks work in partnership with its clients specialising in Commissioning, Calibration and Operations and Maintenance work scopes.
Our 650+ strong staff work across 24 locations in EMEA & North America gaining exposure to the very latest technologies and innovations. At LotusWorks, we believe that embracing a diverse and inclusive culture is integral to our people first strategy. With people from 20 unique nationalities throughout our teams across the globe, we are proud of the diverse array of cultures and continuously ensure employees culture is recognised and celebrated throughout the business.
We lead by putting our people first and we are dedicated to supporting employees in developing their careers within the company, so that each LotusWorker can reach their full potential.
Your Job Purpose:
As the Calibrations Team Lead working with the LotusWorks team, you will join our client site in the Biologics sector. This job is based in a cutting-edge facility in Dundalk.
Working with the LotusWorks team as a Calibrations Team Lead, you will provide engineering support for calibrations and instrumentation across the client site in a highly automated environment. You will own the site calibration program with responsibility for ensuring compliance with EHS and Quality Regulations.
Your Job Description:
- Managing a team of Calibration Technicians to ensure that the site Calibration Program follows all Regulatory requirements including Quality (GMP), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as local regulatory requirements.
- Ensuring compliance to Calibration SOPs, EWIs and Job Plans as the project moves through the commissioning and into the sustaining phase.
- As the calibrations program owner support all compliance – complete risk assessments, investigations, identify appropriate CAPAs etc. to ensure no reoccurrence issues.
- Establish high performance standards including development of appropriate metrics to track instrumentation reliability, calibration efficiency, deviations, out of tolerance.
- Supporting the project by supporting instrumentation criticality assessments being developed by your team.
- Managing, reviewing, and updating the CMMS data, calibration data sheets, Spare parts requirements, PMs, PDMs, job plans etc. to ensure that all maintenance schedules are designed to deliver cost effective, efficient reliability-based maintenance programmes maximising uptime.
- Performing and facilitating root-cause failure analysis (Cause Mapping) on chronic/critical/high impact failures.
- Minimizing unscheduled equipment downtime through effective preventative and predictive maintenance programs and rapid response to equipment failure.
- Using the CMMS, review and accept maintenance reports from Vendors and contractors, develop action plans etc. to address any issues. Raise CMs/PMs/PDM etc. to ensure the issues are appropriately addressed.
- Supporting audits as required.
Job Requirements:
- BEng qualification in an engineering discipline. An Instrumentation related qualification is desirable.
- At least 8 years of experience working in pharmaceutical manufacturing facilities.
- Experience dealing with regulatory agencies. Working knowledge of Maximo, Planning and Schedule activities.
- Detailed knowledge and experience of instrumentation, automation systems and calibration programs.
- Detailed knowledge and experience in the pharmaceutical/biopharmaceutical industry, with in- depth knowledge of regulatory requirements (safety, quality and calibrations.
Proud To Be:
- 7 Consecutive Years A Great Place To Work
- 5 Consecutive Years Deloitte Best Managed Company
- Culturally Diverse Workforce
Benefits Just For You:
- VHI Healthcare Cover
- Life Assurance
- Pension Contribution
- Training And Educational Assistance
- Annual GP Check-Up
- Extra Annual Leave
- Healthcare Screening
- Recognition Rewards
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