Manufacturing Associate

Job Title: 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. 

This is a 12-hour, rotating position for within our Downstream Manufacturing team at our 8 NYA facility. 8 NYA is an integrated, continuous, biomanufacturing facility (ICBF). The facility is operated by Upstream, Downstream and Support Service groups which support a 24/7 large-scale therapeutic protein manufacturing facility housing multiple products.

Position in a new large scale cGMP biologics facility which includes solution preparation, equipment preparation, upstream operations, and downstream operations.  Initial job responsibilities will include  performing a diverse range of  manufacturing related activities from Operational Commissioning/Shakedown through process validation (PV) and Product Change Over.

The primary job function will be Downstream Operations.  Responsibilities will also include supporting Upstream and Support Operations as necessary. The  Sr. Manufacturing Technician 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 EWI (Electronic Work Instruction) revisions and work order generation.

• 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.

• Performs in process analytical testing using pH, Conductivity, A280 and Osmometers.

Additional Responsibilities

• Demonstrates general knowledge of solution preparation, equipment preparation and automation systems (INFOR, MES, ERP, DeltaV).

• Demonstrates general knowledge and practice of aseptic techniques.

Continuous Improvement

• Contributes to continual improvement of all manufacturing documentation (SOP’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, on accordance with business needs.

About You

Basic Qualification:

• High School diploma/GED OR Associate’s degree with 1-3 years of experience in a cGXP environment, or Bachelors with no prior experience required.

Preferred Qualification:

• Biotech Certificate with 1-3 years experience.

• Effectively uses process automation systems to operate production processes (i.e. DeltaV).

• Familiarity with Deviation Management Systems (i.e. Trackwise, Phenix).

Special Working Condition:

• 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 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.

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