The Cleanroom & Quality Assurance Engineer is responsible for maintaining cleanroom standards and implementing and monitoring quality-related processes in a regulated environment. This hybrid role combines environmental responsibility in the cleanroom with quality assurance tasks, including validations, CAPA management, and documentation control.
RESPONSIBILITIES
Cleanroom Responsibilities:
* Monitor cleanroom hygiene and ensure GMP-compliant practices
* Conduct and evaluate environmental monitoring (microbiological and particulate)
* Train and instruct personnel on cleanroom behaviour and hygiene rules
* Review and document cleaning and disinfection procedures
* Maintain and develop SOPs and work instructions related to cleanroom environmental controls
* Support internal and external audits in the cleanroom area
Quality Assurance Responsibilities:
* Manage and follow up on deviations, CAPAs, and change controls
* Support risk assessments (e.g., FMEA) and root cause analyses (RCA)
* Review and approve sterilization validations
* Monitor and evaluate the bioburden process
* Support qualification and validation of equipment, processes, and test methods
* Maintain and review quality-related documentation (e.g., batch records, test plans)
* Contribute to continuous improvement of the QMS
* Conduct internal audits according to the audit schedule
* Collaborate closely with Production and QC
* Provide temporary support for Quality Control (QC) activities in emergency situations when required
Job Types: Full-time, Permanent
Pay: £30,000.00-£32,000.00 per year
Benefits:
* Additional leave
* Company pension
* Enhanced maternity leave
* Enhanced paternity leave
* Financial planning services
* Free parking
* On-site parking
* Sick pay
Work Location: In person