MSAT Technical Writer - Cleaning Val

Overview

An MSAT role focused on cleaning validation activities within a GMP biopharmaceutical manufacturing environment. The position is responsible for leading cleaning validation programmes, including risk assessments, protocol development, execution oversight, troubleshooting, and continuous process optimisation.

Key Responsibilities

• Author, review, and approve Cleaning Risk Assessments, validation protocols, and final reports.
• Develop and execute cleaning validation strategies, including trial design and protocol development.
• Coordinate validation activities, including sampling execution, data review, and documentation management.
• Investigate cleaning-related issues, perform root cause analysis, and support deviation, CAPA, and change control activities.
• Drive continuous improvement and optimisation of cleaning processes to ensure compliance and operational efficiency.
• Collaborate closely with QA, Manufacturing, Engineering, and Global SMEs to ensure alignment with GMP requirements and corporate standards.
• Provide technical guidance to cross-functional teams on validation strategies, execution plans, and compliance expectations.

Requirements

• Proven expertise in GMP cleaning validation within a pharmaceutical or biopharmaceutical manufacturing environment.
• Strong knowledge of PDE-based cleaning limits, MACO calculations, and risk-based cleaning validation approaches.
• Demonstrated experience leading technology transfer programmes and managing validation lifecycle activities.
• Experience authoring and reviewing validation documentation, including risk assessments, protocols, and reports.
• Strong analytical, troubleshooting, and problem-solving capabilities.
• Effective stakeholder management skills with the ability to work across multiple functions and levels of the organisation.
• Positive, proactive, and collaborative approach with a strong focus on team success.