Our client is a biopharma facility located in the midlands. They have a unique, inclusive culture and people working here are exposed to a broad base of tasks early on in their career. The role of this key team member within the Engineering Department will include responsibility for the maintenance and calibration of all process equipment and utilities. It will include day to day operation of the utilities and systems to support manufacturing and will also include management of projects as required.
• Day to day operation and maintenance of all utilities and systems necessary to support manufacturing and to ensure the safe and efficient operation of all systems. Systems will include purified water, water for injection, Pure steam and plant steam.
• Work with manufacturing, Quality and outside vendors to schedule servicing, Calibration and validation work on equipment and utilities.
• Manage the routine re-qualification of temperature storage areas including the temperature mapping and validation of various fridges, freezers, incubators and cold rooms. Prepare protocols and reports as required for this work.
• Manage the validation and requalification of the GMP autoclave and loads.
• Manage the calibration of instrumentation on plant equipment and utilities and preparation of SOP’s for all items. Maintain the master instrument list for the site and ensure all calibration standards are suitable for use and certified.
• Gather maintenance and calibration data for preparation of SOP’s and setting up of maintenance system and records using CMMS software.
• Identification and management of critical spare parts
• Participate in Engineering Department on cross–functional projects
• Manage any upgrade or improvement projects as required throughout the facility.
• Adhere to safe working practices as set out in the safety statement and other safety instructions. Also, assist in providing a safe place of work for employees and participate/lead risk assessments for all equipment and systems on site.
• Participate in Quality and Safety regulatory audits as required and input to similar supplier audits.
• Setting up and carrying out of environmental tasks required for compliance with IPC licence.
• Operation and maintenance of the onsite plant monitoring system
• Degree/Diploma/Apprenticeship in relevant Engineering discipline.
• Minimum 5 years’ experience in pharmaceutical/healthcare industry.
• Excellent interpersonal and communication skills.
• Knowledge and experience in calibration and validation of utilities and equipment
• Experience with CMMS software
• Experience working with and managing external contractors
• Excellent project management capability
Contact Brian Christensen on 01 6854747 or submit your CV to email@example.com for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747