Senior Manufacturing Associate

Job Title: Senior Manufacturing Associate

Location: Framingham, MA

About the Job

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 is operated 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 scale cGMP biologics facility. Initial job responsibilities will include leading a team responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and commercial operations.

The Sr. Manufacturing Associate will be responsible for performing a variety of

complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Maintains a safe working environment and reporting of incidents/accidents to Manufacturing management.

• Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.

• Follows verbal and written procedures in operating production and equipment 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, SOP revisions, and work order generation.

• Fulfills role of lead trainer on numerous operations and is an area SME.

• Interacts with other support functions such as Quality Assurance, Quality Control, 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 team Supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings and providing technical support as needed.

• May be asked to represent the organization at meetings such as shift scheduling meeting, +QDCI, deviation review meetings and project meetings.

• Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing management and/or appropriate functional area(s)

• Cross train manufacturing personnel.

• Performs in process analytical testing.

• Demonstrates proficient knowledge of automation systems (INFOR, MES, ERP, DeltaV).

• Demonstrates general knowledge and practice of aseptic techniques.

Additional Responsibilities

• Contributes to continual improvement of all manufacturing documentation (SOP’s, EWI’s, MBR’s, OJT’s) to ensure they are current, accurate, and

• clear.

• Supports plant floor continuous improvement initiatives.

*Key Responsibilities may differ among employees with the same job title and

may change over time, in accordance with business needs.

About You

Leadership Qualifications:

• Capable of effective and clear communication that enables teams to execute on key deliverables

Basic Qualifications:

• High School diploma/GED with 5-7 years of experience in a cGXP environment, or a Bachelor’s degree with 3-5 years of experience.

• Must have prior experience in cGMP manufacturing operations.

Preferred Qualifications:

• Bachelor’s degree with 4-6 years of experience in bulk biologics GMP manufacturing.

• Effectively uses process