LotusWorks is an Engineering Services provider specializing in managing Commissioning, Construction Services, Calibration, Operations & Maintenance scopes of work within global manufacturing facilities. LotusWorks operates globally across EMEA and North America partnering with the world’s leading manufacturers across the Semiconductor, Pharmaceutical & Biologics, Medical Device and Data Centre sectors. Our team of Engineering and Technical professionals is immersed in cutting-edge technologies and innovations. LotusWorks is committed to a diverse and inclusive workplace, integral to our people-first approach.
As a Senior Calibration Technician 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 Dunboyne, Co. Meath.
You will be responsible for execution of monthly planned calibrations and co-ordinating daily work schedules. Working hands in the set up and calibration of manufacturing and utility instruments.

SKILLS REQUIRED:

• Minimum 5 years Calibrations Experience in a Pharmaceutical, Bio-Pharmaceutical, Biologics or similar facility.
• A strong knowledge of Calibration Systems and Automation/Controls system.
• Experience dealing with regulatory agencies.
• CCMS and SAP or relevant system experience essential.
• Detailed knowledge and experience of instrumentation, automation systems and calibration programs.
• Literacy in Computer Operating Systems and applications such as Microsoft Windows, Word, Excel, and PowerPoint, etc.
• Detailed knowledge and experience in the pharmaceutical/biopharmaceutical industry, with in- depth knowledge of regulatory requirements (safety, quality and calibrations).
• Possess excellent documentation and written skills.
• Strong client management and communication skills.

EDUCATION / LICENSES / CERTIFICATIONS:

• Level 6 Trade qualification E & I or Instrumentation OR Level 7 in Process and Controls Instrumentation or relevant subjects.

• Co-ordinating a small team of technicians to ensure regulatory requirements are met with regards to the execution of planned calibrations.
• Ensuring compliance to Calibration SOP’s, WI’s and Job Plans are met.
• Using CCMS to capture calibration results and raise compliance reports.
• Maintain all documentation in an organised and controlled manner in accordance with GMP and FDA standards.
• Supporting the engineering team with instrumentation criticality assessments.
• Co-ordination of vendors on site.
• Performing and facilitating root-cause failure analysis on chronic/critical/high impact failures.
• Review and approve third party calibration certification and documentation.
• Work with operation teams as required to facilitate calibration activities.
• Attend daily Tier meeting to update client on activities of the team
• Carry out calibrations in a safe and timely manner.
• Calibration standard management as required.
• Assist in purchasing of equipment or standards as required.
• Using SAP to carry out on demand calibrations.
• Any other duties or responsibilities that may be assigned to you in your role.