Senior Manufacturing Associate

Job Title: Manufacturing Associate

Location: Framingham, MA

Day Shift 12 Hour Rotation: 6:45 am - 6:45 pm

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.

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, SOPs revisions, and work order generation.

• Fulfills role of 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.

About You

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 automation systems to operate production processes (i.e. Delta V).

• Experienced reviewing and creating controlled documents

• Familiarity with deviation management systems (i.e. Phenix).

Special Working Conditions:

• Ability to lift up to 50 lbs.

• Ability to stand on average 10 hours per shift.

• Ability to gown and gain entry to manufacturing areas.

• Ability to work a twelve hour rotating night shift and every other weekend, including holidays as scheduled.

Why Choose Us?

• 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 wellbei