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

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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.