A key member in supporting the execution of operational readiness in the manufacturing facility. The Bioprocessing Maintenance Technician will be responsible for the oversight, scheduling and execution of Preventative Maintenance and Calibration activities relating to the new facility, utilities and process equipment. Will also provide immediate Engineering support to ongoing batch operations and become an SME in a number of systems.
Demonstrate high performance behaviours, ability to work collaboratively within a cross functional team, ability to show independent initiative, to have a focus on continuous improvement and have a strong belief in supporting the right culture in the business.
Management and administration of the site Calibration Maintenance Management System (CMMS), PEMAC.
Management, ownership and execution of the site Maintenance, Calibration and Spare Parts strategies.
Equipment maintenance and calibration SME within the Drug Substance Aseptic Operations team.
Schedule, perform & document preventative and corrective maintenance of process equipment in Drug Substance Facility in accordance with cGMP and Good Engineering Practices (GEP).
Active member of the team who will monitor line performance during batch processing and respond to equipment issues to minimize equipment downtime.
Troubleshoot equipment issues e.g. mechanical, electrical, automation, instrumentation issues within manufacturing facility.
Ensure that all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.
Ensure that maintenance activities are completed in compliance with Site Engineering policies and procedures and documented appropriately in the PEMAC system
Ensure that all work undertaken is reflected accurately in Work Order documentation and documented appropriately in the PEMAC system and/or up to date Engineering / project information files.
Liaise with Engineering & manufacturing team to plan and execute planned preventative maintenance including review of drawings, OEM manuals and identification of required spare parts
Liaise with and support the area Senior Engineer to escalate significant equipment issues, prioritise corrective maintenance between batches and to plan identified CI activities
Participate and support the following processes: Total Productive Maintenance (TPM), Continuous Improvement (CI), 5S, defect walk downs, 5S and quality investigations relating to equipment.
Own individual CI projects as identified through equipment data analysis via TPM & supported by Operations Lead
Review and approve work executed by external contractors such as OEM suppliers & service providers.
Review/prepare maintenance procedures and Engineering Work Instructions (EWIs), and other relevant documentation, where required.
Provide training to colleagues as per site training procedures.
Review equipment spares holding levels and make changes post review.
Any other maintenance related activities as directed by the Operations Lead
Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
Perform role of Shift Lead Designee as required
Experience & Qualifications
More than 3 years’ experience in cGMP Pharmaceutical Operations is essential.
More than 3 years’ experience in Drug Substance Biologics manufacturing is essential.
Vaccine manufacturing experience is preferable along with experience of Grade B/C cleanrooms
Advanced Therapeutics (Cell & Gene Therapy) manufacturing experience is a positive.
Aseptic operations experience is preferable.
The role may operate on rotating shift position and may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend process operations.
Demonstrated experience in the maintenance, repair and troubleshooting of complex equipment including one or more of electrical and mechanical issues is required.
Demonstrated ability to use problem solving tools within a team environment such as 5 Whys, DMAIC e.g. Method 1 is desirable.
Due to the start-up nature of the project there will be an expectation for flexibility and an ability to take on varied tasks at short notice not covered extensively within this job description.
Must be able to read, write and converse in English.
Must have good working knowledge of MS Excel and Word
Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem-solving skills
An ability to work independently, and as a member of a self – managed shift team in a dynamic, fast-paced environment that requires flexibility and initiative.
Technical Engineering qualifications (C&G or equivalent) at a minimum. A Degree in an engineering discipline or equivalent experience preferred.
To be considered for this position apply today or call Paula Ferrie on 01 5252457 If you are interested in finding out more about the above role and would like to be considered for this or other suitable roles that we may have available for your skill set – please attach your CV via the link provided. Please submit your updated CV in Word Format If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Osborne are proud to be an Equal Opportunity Employer. #INDPAUFERRIE #INDOSB1