Manufacturing Associate-Nights at Framingham

The Purification Operations Department performs multi-stage large scale chromatography, tangential flow filtration operations (UF/DF Skid), buffer preparation and cleaning process equipment as part of a 24/7 large-scale therapeutic protein manufacturing facility.

Position Summary
This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

Core Responsibilities

Practices and promotes safe work habits and adheres to Genzymes safety procedures and guidelines.

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

Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.

Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.

Maintains cleanliness and orderliness of process area.

Maintains production area with supplies.

Prepares and operates large scale chromatography systems and TFF operations, and/or buffer preparation operations.

Performs clean in place operations to prepare equipment for manufacturing operations.

Performs batch record review, procedure revisions, and work order generation.

May be responsible for training less experienced or new operators.

May be designated as a lead operator on manufacturing operations.

Utilizes manufacturing knowledge to improve process operations and affect positive change.

Demonstrates ability to troubleshoot basic mechanical operations.

Effectively utilizes Microsoft office applications.
LEADERSHIP QUALIFICATIONS

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

Adhering to all applicable laws and regulations of the places in which we conduct business,
as well as our own Company policies and procedures.

Being honest and treating people with respect and courtesy.

Constantly striving to make Genzyme a great place to work, and a company respected for
the quality of its people and products.

Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in
our dealings and exercising sound judgment in performing our jobs.

BASIC QUALIFICATIONS

High school diploma/GED with 3-5 years of experience in cGXP manufacturing environment, or Bachelors degree with 1-3 years of experience.

PREFFERED QUALIFICATIONS

• Bachelors degree with 2-4 years of experience in bulk biologics cGMP manufacturing.
• Familiarity with Manufacturing Control Systems (i.e. DeltaV).
• Extended experience in large-scale purification operations.
• Experience in a GXP environment.
• Experience facilitating and delivering training.
• Experience creating controlled documents.
• Experience in column packing and qualification. M*

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 (74 NYA site requires changing into scrubs).
• Ability to work a twelve hour rotating shift and every other weekend, including scheduled holidays.
• Ability to work day or night shift, as applicable.
• Ability to work in a cold room environment (2-10 degrees C).

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Country: USA, State: Massachusetts, City: Framingham, Company: Genzyme Corporation.