Job Title: Manufacturing Technician

　　Location: South Plainfield

　　Hours/Schedule: M-F, 8am - 5pm

　　Type: Contract to Hire

　　Overview:

　　Provide daily support for all cGMP manufacturing activities. Includes preparation of all solutions, buffers and all activities associated with an aseptic production area, such as room and equipment cleaning and moving equipment as needed. Follows cGMP guidelines at all times. Takes responsibility to be properly trained and helps to ensure that all training records are kept up-to-date.

　　Responsibilities

　　• Assist in preparation of solutions and buffers for the manufacturing process.

　　• Complies with all pertinent SOPs and/ or master batch record following GMP guidance.

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　　• Familiar with Downstream manufacturing, depth filtration, TFF, and Final Fill.

　　• Assist with production process steps as needed.

　　• Assist with the cleaning/ sanitizing of manufacturing vessels, equipment and other process related items.

　　• Assist with cleaning/ sanitizing of rooms and fixed equipment in the aseptic production area.

　　• Must be able to write SOPs and other GxP documents.

　　• Must be able to assist/ write and implement deviations, investigations, and CAPAs

　　• Daily visual and physical checks/ calibrations of all in-process equipment.

　　• Review and document data with accuracy.

　　• Must be able to setup and execute projects independently.

　　• Must be able to troubleshoot and maintain process equipment.

　　• Must display leadership characteristics.

　　• Must have strong communication skills internal and external to the department.

　　• Must be able to work well with a team.

　　• Must be able to follow written and or verbal direction.

　　Experience making biologic solutions & buffers

　　Experience working in an cGMP aseptic environment (ISO 8 or 7)

　　Experience making biologic solutions & buffers

　　Strong background in Single-Use technology

　　Worked in Downstream manufacturing, depth filtration, TFF, and Final Fill.

　　Education: HS or AS degree / BS a plus not required

　　8-10 years of Aseptic Manufacturing in GMP Pharma/Biotech company

　　High attention to detail.

　　Proven documentation skills.

　　Dedication to production quality.

　　Experience with production planning.

　　Family with equipment calibration techniques

　　#M3

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.