Manufacturing Technician II

Position Title: Manufacturing Technician II
Work Location: Newark, CA
Assignment Duration: 12 Months
Work Arrangement: Onsite (implied by GMP cleanroom / aseptic operations)

Position Summary: The Organization setting the new standard for our clients through our disruptive products and for our employees through our industry-leading benefits that promote financial and physical health & well-being for all employees. The incumbent will be a part of the manufacturing organization and provide hands-on execution of tasks related to the cGMP manufacture of biopharmaceuticals working in aseptic fill-finish.

Key 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.

Qualification & Experience: Minimum Required: · 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.

Preferred: · 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.

Key Competencies: · Integrity, Trust, Ethics, Values · Results oriented · Strategic Skills · Organizing/Priority Setting · Communication skills · Attention to detail · Decision Quality · MS Word Proficient · Flexibility · Interpersonal Savvy · Negotiating · Problem Solving · Listening & Approachability · Partnering

Education: Minimum Required: · High School Degree or Equivalent

Preferred: · Bachelor’s degree in biological sciences, chemical engineering or related discipline

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $28.00/hr – $29.00/hr.