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Commissioning & Qualification Engineer (Process Development)
1 month ago
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Commissioning & Qualification Engineer (Process Development), Sligocol-narrow-left
Client:Cpl
Location:Sligo, Ireland
Job Category:Other
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EU work permit required:Yes
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Job Reference:81418737d883
Job Views:3
Posted:27.04.2025
Expiry Date:11.06.2025
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Job Description: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 organisation's 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 options for hybrid, remote, or in-office work. 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. Coordinate and execute 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 SME's where necessary.
- Responsible for the execution of routine (PQ) & cycle development temperature mapping on the same equipment.
- Analyse, interpret, and report on validation testing against acceptance criteria.
- Execute 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.
- Derive process-specific documents from standard template designs.
- Engage & communicate task progress and actions through meetings, presentations, and reports to management, customers, & suppliers.
- Stay up to date with industry trends, regulatory changes, and advancements in sterilisation/washing technology.
- Provide technical expertise on autoclave cycle development and sterilisation & washing principles, together with our SME's.
- Due to the nature of this work, extended stays at customer locations are expected.
- Support other C&Q work and team as required.
- Ensure safety procedures are adhered to at all times.
- Reflect the company's goals and values at all times.
Requirements:
- Technical writing skills, with an excellent understanding of 'Plain English' writing technique.
- Experience with autoclave, equipment validation, instrument calibration, and familiarity with 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 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.
- Strong grasp of physics principles affecting autoclave cycle development.
- Understanding of sterilisation principles and regulatory guidelines (e.g., EU GMP annex 1, ISO, EN).
- Understanding of GMP washing principles and regulatory guidelines (e.g., EudraLex Vol. 4, ASME BPE, ISO).
- Ability to interpret technical documents such as drawings, process specifications, safety protocols, and policies.
- Clear understanding of equipment validation lifecycles in the pharma industry.
- Ability to work independently, adhere to schedules, and execute validation studies.
- Capability to manage multiple deliverables successfully and on time.
- Ability to communicate validation requirements effectively with customers and suppliers.
- Strong analytical and organizational skills, with attention to detail.
- Proactive attitude and drive to meet objectives and targets.
- Proficiency in standard MS Office packages.
