Specialist Manufacturing; JP

Specialist Manufacturing

Operations is one of three foundational functions at our client with a mission to manufacture and deliver safe and effective medicine to patients around the world. The Operations Program at the Rhode Island site is divided into five functions:
Supply Chain, Process Development, Quality, Manufacturing, and Facilities & Engineering.

We are currently seeking highly motivated, hardworking individuals who will directly support Manufacturing operations in their newest Next Generation Biomanufacturing plant. Along with key business partners and functional groups, this position will focus on directly supporting manufacturing operations and new product introductions.

The primary responsibilities for this role may include, but are not limited to the following:

• Support of manufacturing operations.
• Management of Manufacturing process documentation per required process in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
• Initiating and owning quality records (e.g. change controls, deviations, CAPAs).

Top Must Have

Skills:

• GMP experience.
• Technical writing experience.
• Development of regulated or process documents with the ability to deliver high quality documentation.

Day to Day Responsibilities:

• Support of manufacturing operations.
• Management of Manufacturing process documentation per required process in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
• Initiating and owning quality records.

Basic Qualifications:

Bachelor's degree in Engineering, Science or related field.

Preferred Qualifications:

• 3 or more years of experience in Cell Culture or Purification execution and/or support.
• Single use technology experience.
• Proficient on Microsoft Office Suite.
• Ability to work independently and as a team player.
• Excellent collaboration and problem solving skills.
• Ability to work virtually.
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles.
• Experience with Manufacturing execution and automation systems.
• Experience with lab equipment/testing.
• Experience in influencing and negotiation.

Employee Value Proposition:

• Great Biotech/pharma to work for.
• Grow their skillset.

Red Flags:

Inexperience in GMP and technical writing.