Job title: Manufacturing Associate

Location: Framingham, MA

About You

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

8 NYA is an integrated, continuous, biomanufacturing facility (ICBF). The facility isoperated by upstream, downstream and support services groups which support a 24/7 large-scale therapeutic protein manufacturing facility housing multiple products.

This is a 12-hour, rotating position in a flexible, single-use technology, large scalecGMP biologics facility. Initial job responsibilities will include leading a teamresponsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) andcommercial operations.

• Maintains a safe working environment and reporting of incidents/accidents to Manufacturing management.
  
• Effectively demonstrates understanding of GMPs and how they apply tospecific responsibilities.
  
• Follows verbal and written procedures in operating production andequipment and performing processing steps; accurately completes
  
• appropriate production documentation.
  
• Maintains cleanliness and orderliness in process area. Ensures production area is stocked with supplies.
  
• Performs batch record review, SOPs revisions, and work order generation.
  
• Interacts with other support functions such as Quality Assurance, QualityControl, Manufacturing Engineering, MSIT, Validation, etc.
  
• Utilizes manufacturing knowledge to improve process operations and affect positive change.
  
• Demonstrates ability to troubleshoot basic mechanical operations.
  
• Effectively utilizes Microsoft Office applications.
  
• Mentors less experienced operators.
  
• Fulfills the role of Team Lead in the absence of the Manufacturing Sr.Associate.
  
• Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or informationsystems to Manufacturing management and/or appropriate functionalarea(s).
  
• Performs in process analytical testing.
  
• Demonstrates general knowledge of automation systems (INFOR, MES,ERP, DeltaV).
  
• Demonstrates general knowledge and practice of aseptic techniques.
  

• Cross train manufacturing personnel
  

• Contributes to continual improvement of all manufacturing documentation (SOP's, MBR's, OJT's) to ensure they are current, accurate, andclear.
  
• Supports plant floor continuous improvement initiatives.
  

• High School diploma/GED with 3-5 years of experience in a cGXPenvironment, or a Bachelor's degree with 1-3 years of experience.
  
• •Must have prior experience in cGMP manufacturing operations.
  

• Bachelor's degree with 2-4 years of experience in bulk biologics GMP manufacturing.
  
• Effectively uses process automation systems to operate production
  
• processes (i.e. Delta V).
  
• Familiarity with deviation management systems (i.e. Veeva Vault).
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.