MSAT Engineer / Consultant

Key Responsibilities:

Deliver various projects in the competency area of manufacturing science and technology (MSAT) and related functions such as validation and quality. Potential scope of projects include:

• Author and review Extractables and Leachables (E&L) Risk Assessments.
• Generate strategy for bioburden, endotoxin, buffer / media mixing performance qualification (PQ), media / buffer hold time PQ, etc.
• Support single use material introduction including technical assessment and qualification strategy alignment.
• Plan and execute PQ including authoring reports and results that may include data trending and analysis.
• Author and review other process related qualification and validation activities including in Cleaning Validation (CV), Sterilization-in-Place (SIP), resin lifecycle, etc.
• Troubleshoot cleaning issues and support investigations and CAPA.
• Draft other deliverables within full CQV cycle such as UR...