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.
Responsibilities:
* 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.
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.
Benefits:
* VHI Healthcare Cover
* Life Assurance
* Pension Contribution
* Training And Educational Assistance
* Annual GP Check-Up
* Extra Annual Leave
* Healthcare Screening
* Recognition Rewards
INDHP
LotusWorks is an equal opportunity employer and prohibits discrimination and harassment of any kind. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and empowered.