DEPARTMENT DESCRIPTION:
This is a bulk production operation for fermentation, purification, drying and aseptic fill.
POSITION OVERVIEW WITH KEY RESPONSIBILITIES:
Position Summary
Works with a team of Associates and Technicians to complete daily manufacturing responsibilities.
Core Responsibilities
Follows standard operating procedures in a cGMP environment.
Operates manufacturing equipment, large scale processing tanks and fermenter and dryer.
Performs routine equipment (CIP, COP and SIP) and area cleaning procedures.
Independently executes support functions such as routine equipment cleaning based on published schedules.
Follows safety guidelines.
May engage in cross-training between HA departments.
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:
Respecting the laws and operating within the applicable 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:
Associate's Degree or 2+years’ experience in a manufacturing environment.
Basic computer skills, basic math and problem-solving skills.
Ability to multi-task.
Ability to read and comprehend instructions, short correspondence, and memos.
Ability to operate complex manufacturing equipment.
Good documentation skills.
PREFERRED QUALIFICATIONS:
Minimum of 3 years cGMP experience.
Experience with ERP software
Special Working Conditions:
Individuals are required to work within a cGMP clean room and controlled environment.
This position also requires physical demands of lifting up to 30 pounds.
Must be willing to work weekends or required to work overtime to meet production demands
Operates general manufacturing equipment under close supervision in accordance with current GMPs or standardized procedures and within safety guidelines.
Requires good documentation skills and attention to detail.
Tasks to be completed may include fermentation, protein purification, solvent extractions, tissue culture, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer and media preparation, filtration, vial preparation and sterilization.
Operates general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above.
Brings deviations in process protocols to supervisors attention.
Maintains all associated documentation for operations being performed.
Reviews and records physical inventory of stock items.
Requires very few, if any of the requisite skills to perform the required tasks of the position at this level.
Receives detailed instructions on all work.
All activities are closely supervised and work is reviewed upon completion.
Receives general instructions on new work, which is generally reviewed upon completion.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job.
May involve work with hazardous materials. Experience: 0 to 3 years.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.