Commissioning & Qualification Engineer (Process Development)
Our company is seeking a skilled Commissioning and Qualification Engineer to support the development of pharmaceutical and biopharmaceutical processes. The ideal candidate will have expertise in thermal mapping, process development, and validation, with a strong understanding of GMP principles.
Key Responsibilities:
* Develop and execute cycle development and performance qualification studies on process equipment, including autoclaves, washers, bioreactors, and vessels.
* Analyse cycle performance data, troubleshoot issues, and implement improvements where necessary.
* Collaborate with cross-functional teams to support ongoing sterilisation and washing needs, and assist with deviation and exception resolution.
* Liaise with internal and supplier subject matter experts as required.
* Execute routine performance qualification and cycle development temperature mapping on process equipment.
* Analyse and report on validation testing against acceptance criteria.
* Prepare and execute validation documentation, including protocols, qualification reports, and procedures.
* Ensure compliance with GDP regulations.
* Calibrate thermocouples and perform post-study calibration verifications.
* Derive process-specific documents from standard templates.
* Communicate task progress and actions through meetings, presentations, and reports to management, customers, and suppliers.
* Stay up-to-date with industry trends, regulatory changes, and advancements in sterilisation and washing technology.
* Provide technical expertise on autoclave cycle development and sterilisation and washing principles.
* Manage test equipment.
* Support extended stays at customer locations as required.
* Support other C&Q work and team members as needed.
Requirements:
* Excellent technical writing skills, with a strong understanding of plain English writing techniques.
* Experience with autoclave equipment validation, instrument calibration, and datalogger systems (E-Val Pro or equivalent).
* 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.
* Familiarity with different types of autoclaves, including porous load, air/steam mixture, superheated water, etc.
* Strong working grasp of physics principles affecting autoclave cycle development.
* Understanding of sterilisation and washing principles, and relevant regulatory guidelines (e.g., EU GMP annex 1, ISO 17665, EN285).
* Ability to read and interpret technical documents, such as drawings, specifications, safety protocols, and company policies.
* Demonstrated clear understanding of equipment validation lifecycles in the pharma industry.
* Ability to work independently, manage concurrent deliverables, and execute validation studies on time.
* Excellent communication and presentation skills, with the ability to converse with customers and suppliers.
* Attention to detail and organisational skills are essential.
* Proficiency in MS Office packages is required.