Commissioning & Qualification Engineer (Process Development)
My client, 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, hybrid, remote and in office. The key stakeholders associated with this role are the Commissioning Manager (reporting to), Process Validation Manager, Projects Director, Operations Director, internal SME, Customers (all) & Suppliers (all).
Responsibilities:
- Be accountable, customer focused & collaborative. Coordinating and execution of 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 assisting with deviation and exception resolution.
- Liaising with internal & supplier SME’s where necessary.
- Responsible for the execution of routine (PQ) & cycle development temperature mapping on same equipment.
- Analysing, interpretation and reporting on validation testing against acceptance criteria.
- Execute particular validation documentation including protocols, qualification reports, summary reports, procedures, other lifecycle documents.
- Ensuring GDP is adhered to.
- Calibrating thermocouples and performing post-study calibration verifications
- Derivation of process-specific documents from standard template design.
- Engage & communicate task progress and actions through meetings, presentations, and reports to management, customers & suppliers.
- Staying up to date with industry trends, regulatory changes, and advancements in sterilisation/washing technology.
- Together with our SME’s, 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 is expected.
- Supporting other C&Q work and team as required.
- Ensuring that safety procedures are adhered to at all times.
- At all times this person needs to reflect the company’s goals and values.
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.
- Have a strong working grasp of physics principles that affect autoclave cycle development.
- Strong understanding of sterilisation principles, and regulatory guidelines (e.g. EU GMP annex 1, ISO 17665,EN285).
- Strong understanding of GMP washing principles, and regulatory guidelines (e.g. EudraLex Vol. 4, ASME BPE, ISO 17665).
- 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.
- Being able to work on your own initiative, to pre-determined schedules, and execute validation studies.
- Ability to successfully manage concurrent deliverables on time.
- Be able to converse with, present on and interrogate customer/supplier validation requirements.
- Ability to analyse and organise complex material. Attention to detail.
- Having the right attitude and drive to meet objectives and targets.
- A demonstrated proficiency in the standard MS packages.
- Organised, adaptable & flexible.
For more information, please email [email protected]
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