Manufacturing Specialist
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Start: ASAP
Engagement: 1 year Contract
We are looking for an experienced Manufacturing Specialist to support manufacturing activities within a GMP-regulated pharmaceutical or biologics environment. The role will focus on manufacturing readiness, operational support, technical investigations and documentation, working closely with Manufacturing, Quality and Engineering teams.
Key ResponsibilitiesDevelop and update batch manufacturing documentation, change controls, GMP documentation and operational risk assessments.
Support manufacturing readiness, process transfers, campaign preparation and training activities.
Review and investigate manufacturing deviations, identifying root causes and assessing potential product or process impact.
Manage CAPAs and investigation-related actions through to timely closure.
Support the assessment and disposition of non-conforming or rejected materials.
Identify manufacturing trends and lead technical investigations where required.
Provide technical input during manufacturing campaigns and support resolution of operational issues.
Support audit and inspection readiness, ensuring documentation and investigations meet GMP expectations.
Work closely with Manufacturing, Quality, Engineering and other technical stakeholders to support manufacturing execution and timely product release.
Degree in Engineering, Biotechnology, Life Sciences or a related discipline.
Relevant experience within GMP pharmaceutical, biotechnology or biologics manufacturing .
Good understanding of manufacturing processes, equipment and GMP requirements.
Hands-on experience with deviations, CAPAs, change controls, batch documentation and root cause investigations.
Strong technical writing and documentation skills.
Good communication and stakeholder management capabilities.
Comfortable working independently in a fast-paced manufacturing environment and managing changing priorities.
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