Technical Writer- manufacturing - OQSIE

This is primarily a Technical Writer position supporting Biologics Manufacturing Group in 

producing technical documents such as Material Specifications, Standard Operating Procedures 

(SOP’s), Phase appropriate tech Guidance documents and technical reports.  Some specific 

responsibilities are as follows: 

1. Support author of material specifications for single-use components and raw materials, and help build a specification database for incoming materials and inventory tracking 

1. Support Author GMP manufacturing operations related SOPs as assigned 

1. Development Phase appropriate Phase 1 Risk Assessments tied to cGMP Mfg, as required.   

• Phase Appropriate Qualification of Raw materials 

• Microbial testing Risk Assessment 

• Specific Risk Assessment of New Programs  

• Risks assessment for instruction of MCBs into 

• Extractable  /Leachable Phased Approach 

• Long Term Storage and Reuse of Resins and Membrane 

1. Maintain compliance with Good Documentation Practices (GDP) 

1. Facilitate cross-functional reviews, feedback, comment resolution, and approvals for technical documentation against program timelines using the company systems 

1. May provide suggestions on upstream and downstream biologics manufacturing operations enabling strategies for consideration.