OVERVIEW

The Cleanroom & Quality Assurance Engineer is responsible for maintaining cleanroom standards and implementing and monitoring quality-related processes in a regulated environment. This role combines environmental responsibility in the cleanroom with quality assurance tasks, including validations, CAPA management, and documentation control.

REQUIREMENTS

• Degree or vocational training in biotechnology, medical technology, microbiology, pharmacy, or a related field
• Minimum 2 years of experience in a GMP-regulated environment (e.g., medical devices, pharmaceuticals)
• Solid knowledge of ISO 13485, GMP, and hygiene management
• Experience with CAPA, risk analysis, validations, and documentation systems
• Proficient in Microsoft Office (Outlook, Word, Excel)
• Structured, independent, and detail-oriented working style
• Strong communication and teamwork skills
• Good command of English, both written and spoken
• Experience with internal audits would be an advantage.
  Job Types: Full-time, Permanent
  Pay: £30,000.00-£35,000.00 per year

Benefits:

• Company pension
• Enhanced paternity leave
• Free parking
• On-site parking
• Sick pay

Work Location: In perso

• 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