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