A Senior Cold Chain Engineer is required on a PERMANENT basis by CareerWise Recruitment for our Cork based Biopharmaceutical Client.
TCU (Temperature Controlled Units) - Refers to all permanent, portable and temporary units that are designed and qualified at the client site for the storage of material at cold temperature ranges (2-8, ≤-20, ≤-60 and cryogenics).
The Senior Cold Chain Engineer is the site SME (Subject Matter Expert) for Material Management TCUs (Temperature Controlled Units) and is responsible for overseeing all aspects of their qualification, operation, maintenance and retirement, including alarm rationalisation and control strategies. They will be the system Owner for all Materials Management TCUs and Cryogenics equipment at Client Site.
The Senior Cold Chain Engineer will work cross functionally with operations, process scientists, quality assurance, automation, maintenance and others. Engineers are a core function at Kinsale and are highly regarded and responsible in their positions.
Role of this position
- Ownership for equipment qualified state through Commissioning & Qualification (C&Q), Requalification (RQ), oversight of maintenance and Periodic Review Reports (PRRs)/Asset Qualification Management (AQM).
- Troubleshoot and investigate equipment issues utilising root cause analysis techniques, including deviation lead investigator.
- Define process monitoring and alarm monitoring requirements, and alarm rationales/strategies.
- Act as consult for OOH (out of hours) alarms.
- Work with automation and user groups to manage Pi groups and build interactive user dashboards to monitor and trend alarms / performance.
- Frontline audit support for TCUs and cryogenic equipment. This will include but is not limited to qualification, control strategy, alarm parameters and operation.
- In partnership with maintenance planner and vendor, maintain spare parts strategy based on best practices and vendor recommendations.
- Raise and critically review equipment related change controls.
- Deliver new Standard Operating Procedure (SOP) for changes to TCUs and associated control strategies.
- Coordinate with business owners in defining cold chain recapitalisation strategies.
- Build technical expertise and manage Business Continuity Plan (BCP) for all Materials Management TCUs and cryogenics.
- Work with business partners, procurement, and vendors to build robust SLAs (Service Level Agreement) and develop preventative maintenance programme TCUs.
- Generate, approve and/or advise on technical training material on TCUs and cryogenics.
- Hons Degree qualified - Engineering or Science discipline with ideally 3-5 years' relevant experience in GMP manufacturing.
- Experience in equipment troubleshooting, Cold Chain/TCU systems and qualification.
- Experience with GMP/HPRA/FDA regulatory requirements and current Health and Safety standards.
Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)