Commissioning & Qualification Engineer (Process Development)
CPL, a premier supplier of cutting-edge pharma equipment in Ireland and the UK, is looking to add a talented C&Q (Process Development) professional to support their pharmaceutical and biopharmaceutical clients and suppliers. The core function of this role will be to provide thermal mapping, process development, and validation support, offer technical and scientific expertise to both the organisations team and their customers, and be primarily responsible for the optimisation & qualification of autoclave and washer cycles, within a GMP pharmaceutical environment.
This position offers a dynamic work environment and the opportunity to collaborate on innovative projects within the industry with the option of working in a hybrid, remote, or office setting. The key stakeholders associated with this role are the Commissioning Manager (reporting to), Process Validation Manager, Projects Director, Operations Director, internal SME, Customers (all), and Suppliers (all).
Responsibilities:
* Be accountable, customer-focused, and collaborative, coordinating and executing cycle development and performance qualification studies on upstream and/or downstream process equipment including autoclaves, GMP washers, bioreactors, process skids, and vessels.
* Analyse cycle performance data, troubleshoot issues, and implement improvements where necessary.
* Collaborate with cross-functional teams, including Quality Assurance, Engineering, and Production, to support ongoing sterilisation and washing needs, and assist with deviation and exception resolution.
* Liaise with internal & supplier SMEs where necessary.
* Responsible for the execution of routine (PQ) & cycle development temperature mapping on same equipment.
* Analyse, interpret, and report on validation testing against acceptance criteria.
* Execute particular validation documentation, including protocols, qualification reports, summary reports, procedures, and other lifecycle documents.
* Ensure GDP is adhered to.
* Calibrate thermocouples and perform post-study calibration verifications.
* Stay up-to-date with industry trends, regulatory changes, and advancements in sterilisation/washing technology.
* Together with our SMEs, provide technical expertise on autoclave cycle development and sterilisation & washing principles.
* Test equipment management.
* Due to the nature of this work, extended stays at Customer location are expected.
* Support other C&Q work and team as required.
* Ensure that safety procedures are adhered to at all times.
* Reflect the company's goals and values at all times.
Requirements:
* Technical writing: an excellent understanding of 'Plain English' writing technique.
* Experience of autoclave, equipment validation, instrument calibration, and a track record or knowledge of using the E-Val Pro wired validation system (or equivalent datalogger is desirable but not essential, as full training will be provided).
* Relevant Degree or comparable qualification in an engineering, science, or validation discipline.
* Proven experience in autoclave and washer cycle development and validation within a GMP-regulated pharmaceutical or biopharmaceutical environment.
* Experience with different types of autoclaves, including porous load, air/steam mixture, superheated water, etc.
* A strong working grasp of physics principles that affect autoclave cycle development.
* A strong understanding of sterilisation principles and regulatory guidelines (e.g. EU GMP annex 1, ISO, EN).
* A strong understanding of GMP washing principles and regulatory guidelines (e.g. EudraLex Vol. 4, ASME BPE, ISO ).
* The ability to read and interpret documents such as technical drawings, process specifications, safety protocols, company policies, and procedure manuals.
* A demonstrated clear understanding of equipment validation lifecycles in the pharma industry.
* The ability to work on your own initiative, to pre-determined schedules, and execute validation studies.
* The ability to successfully manage concurrent deliverables on time.
* The ability to converse with, present on, and interrogate customer/supplier validation requirements.
* The ability to analyse and organise complex material, attention to detail.
* The right attitude and drive to meet objectives and targets.
* A demonstrated proficiency in the standard MS packages.
* Organised, adaptable, and flexible.