Manufacturing Specialist II, Technical Operations

Role Summary

In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.

Responsibilities

• Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records
• Management and project execution ‚Äì participate in projects (simple to moderately complex in nature), facilitating timely execution
• Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation
• Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met
• Initiate, own, and manage manufacturing focused change controls, CAPAs, investigations, and planned exceptions
• This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support

Qualifications

• Bachelor‚Äôs degree (Life Sciences or Engineering) preferred, with 0-1 years of transferrable experience
• Associates Degree or Bioworks Certificate and 2 years of transferrable experience
• High School Diploma (or Equivalent) 4 years of transferrable experience

• Prior experience in manufacturing ‚Äì drug product operations
• Understanding of business processes and roles of cross-functional groups supporting manufacturing operations
• Robust understanding of quality and cGMP principles
• Fundamental knowledge of change control in cGMP environment
• Intermediate to advanced skills in Microsoft Office and computer-based quality systems
• Intermediate to advanced level of technical writing skill
• Ability to interpret manufacturing process design documentation
• Excellent oral and written communication skills

Skills

Education

Additional Requirements