Manufacturing Specialist

Manufacturing Specialist

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 Responsibilities

• Develop 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.

Requirements

• 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.