Manufacturing Associate Level II

Job Title:

Manufacturing Associate Level II

Location:

Edison, NJ

Type:
Contract To Hire

Compensation: $20.00

Work Model:
Onsite

Responsibilities

+ Prepare and maintain buffers and media required for downstream processes.

+ Ensure accurate formulation and timely availability of all solutions.

+ Maintain detailed records of preparation and usage.

+ Operate and maintain chromatography systems for protein purification.

+ Monitor process parameters and ensure consistent product quality.

+ Troubleshoot and resolve any issues that arise during chromatography runs.

+ Perform TFF operations for concentration and diafiltration of biopharmaceutical products.

+ Optimize TFF parameters to achieve desired product specifications.

+ Document all TFF activities and results.

+ Conduct viral filtration to ensure the safety and purity of biopharmaceutical products.

+ Validate and monitor viral filtration processes.

+ Maintain compliance with regulatory standards for viral safety.

+ Perform aseptic processing in a clean room environment.

+ Adhere to strict aseptic techniques to prevent contamination.

+ Ensure compliance with Good Manufacturing Practices (GMP).

+ Maintain a clean and organized work environment.

+ Follow all clean room protocols and procedures.

+ Participate in regular clean room maintenance and cleaning activities.

+ Maintain accurate and detailed records of all manufacturing activities.

+ Ensure compliance with GMP and regulatory requirements.

+ Participate in audits and inspections as needed.

+ Other duties as assigned.

Requirements

+ Ability to follow instructions and procedures.

+ Excellent problem-solving and analytical skills.

+ Effective communication, leadership and teamwork abilities.

+ Strong knowledge and experience working in a biopharmaceutical cGMP- regulated environment.

+ Must have GMP Manufacturing experience in Pharmaceuticals, Medical Devices, Biologics, Cleanroom environments, or Chemical Processing.

+ Bachelor's degree in biotechnology, Biochemistry, Chemical Engineering, or a related field with 3+ years of relevant experience.

+ H.S diploma with 4+ years of experience will be considered in lieu of Bachelor's Degree.

+ Technical training or certifications are a plus.

+ Must be comfortable working in cleanroom and sterile environments, with ability to follow strict protocols.

+ Strong interest in a cross-functional manufacturing role with growth opportunity.

+ Must have flexibility with supporting hours outside of 8am-5pm when needed.

+ Open to a Temp-to-Hire opportunity for long-term employment (Others have converted recently).

+ This position requires the ability to stand for extended periods, bend, and lift objects weighing up to 50 pounds.

+ Candidates must be physically capable of performing these tasks safely and effectively.

+ Requires availability to work flexible shifts including overtime, evenings, weekends and holidays, as operational needs require.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.

#M- #LI- : #550-Joule Headquarters

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.