Manufacturing Technician II
Spectraforce
Newark, California
7 days ago
Job Description
Position: Manufacturing Technician II
Location: Newark, CA
Duration: 12 Months
ESSENTIAL DUTIES
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.
Skills:
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:
· 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.
Location: Newark, CA
Duration: 12 Months
ESSENTIAL DUTIES
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.
Skills:
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:
· High School Degree or Equivalent
Preferred:
· Bachelor’s degree in biological sciences, chemical engineering or related discipline
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
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.