Position Title: Manufacturing Technician II
Work Location: 7555 Gateway Boulevard, Newark, CA
Assignment Duration: 9 months

Work Arrangement: Onsite

Position Summary:
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.
The incumbent will demonstrate the ability to execute critical and complex cGMP tasks and will demonstrate flexibility to support business needs.

The incumbent will work with area management to execute and maintain the production schedule.

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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.

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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.

COMPETENCIES

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 starting pay is: $ 28.37/hr.