Clean Room Assistant
Location: Cheshire
Department: Manufacturing
Reporting to: Site Head
Role Summary
We are seeking a Cleanroom Assistant with proven experience in GMP-regulated environments, particularly within cleanroom operations. This role involves hands-on participation in the manufacture of bioconjugates, including antibody drug conjugates, within a dynamic and project-driven Contract Development and Manufacturing Organisation (CDMO). The successful candidate will play a key role in supporting operational readiness and continuous improvement in a newly established manufacturing facility.
Key Responsibilities
Ensure full compliance with current Good Manufacturing Practice (cGMP) standards across all manufacturing activities.
Operate within classified cleanroom environments, maintaining strict hygiene and contamination control protocols.
Perform daily production operations, including equipment setup, material preparation, and process monitoring.
Maintain high standards of cleanliness and aseptic technique throughout the facility.
Accurately complete documentation including batch records, logbooks, and SOPs with clarity and precision.
Prepare, clean, sterilise, inspect, and maintain production equipment and cleanroom facilities.
Conduct sampling, testing, and analysis of materials used in production.
Support EHS compliance, ensuring adherence to safety protocols and participating in audits and training.
Assist in validation activities and waste treatment operations.
Receive, transport, and store materials in accordance with GMP and EHS guidelines.
Identify and implement opportunities for continuous improvement and preventative maintenance.
Key Competencies
Demonstrated experience in GMP manufacturing, with a strong understanding of cleanroom operations and safe systems of work.
Background in pharmaceutical or life sciences manufacturing, ideally with exposure to biologics or bulk drug substance production.
Familiarity with process equipment, P&IDs, aseptic processing, and basic laboratory techniques.
Strong attention to detail and methodical approach to work procedures.
Ability to work independently and as part of a team, with a proactive and self-starting attitude.
Competency in Microsoft Office applications including Outlook, Word, Excel, and PowerPoint.
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