Job Description
Position Title: Manufacturing Technician I
Work Location: 7555 Gateway Boulevard, Newark, California, USA
Assignment Duration: 12 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.
Background & Context:
The incumbent will work with area management to execute and maintain the production schedule within our organization’s manufacturing operations.
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.
-
Supports the closure of CAPA and CR Tasks as required per business needs.
-
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.
Qualification & Experience:
Minimum Required:
-
0–3 years of experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.
Preferred:
-
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.
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
Working Conditions & Physical Demands (If Applicable):
-
Ability to stand for extended periods of time.
-
Must be able to lift up to 25 pounds at times.
Education:
Minimum Required:
-
High School Degree or Equivalent
Preferred:
-
Bachelor’s degree in biological sciences, chemical engineering or related discipline
Mobile-Optimized JD Summary (280 characters):
Manufacturing Technician I needed onsite in Newark, CA for 12 months. Hands-on GMP manufacturing supporting aseptic fill-finish, cleanroom operations, documentation, and cross-functional production support.
- 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: $ 23.64/hr.