Manufacturing Technician II

ICONMA, LLC • United States, United States • 1d ago

Our Client, a Biotech company, is looking for a Manufacturing Technician II for their Newark, CA (onsite) location. Responsibilities:

Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.) and can serve as the lead in these activities.

Operate in a controlled GMP environment.

Ensure compliance with established internal and external control procedures.

Demonstrates operational proficiency in Drug Product-related process equipment.

Assist in the execution of process, equipment and cleaning validation.

Assist with support tasks within Drug Substance Manufacturing, as business needs permit.

Responsible for revising and originating production records, standard operating procedures, protocols and reports.

Initiate and supports the closure of Deviation Reports

Supports the closure of CAPA and CR Tasks as required per business needs.

Train and mentor new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skills.

Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion.

Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments.

Supports the ongoing continuous improvement within the Drug Manufacturing Process.

May schedule team activities within the manufacturing facility including the coordination of production schedules, calibration and validation.

May coordinate schedule with process science teams, analytical testing personnel, microbiological support team, facilities and sanitization groups.

Requirements:

High School Degree or Equivalent

Bachelor's degree in biological sciences, chemical engineering or related discipline

3+ years of experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.

Hands-on skills with Aseptic technique, cleanroom gowning and extensive knowledge of Good Manufacturing Practices (GMPs).

Hands-on skills with aseptic fill finish operation.

Hands-on experience with automated filling/capping machine, and Lyophilizer.

Experience with process development, transfer, and optimization is a plus.

Experience with execution of validation protocols is a plus.

Experience working with potent/toxic agents is a plus.

Why Should You Apply?

Health Benefits

Referral Program

Excellent growth and advancement opportunities

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

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