Manufacturing Technician I-IV - Media/Buffer
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
SUMMARY:
The Manufacturing Technician I-IV, Media/Buffer directly impacts commercial, late stage, PPQ production through dynamic manufacturing support duties and sanitization activities.
PRINCIPAL RESPONSIBILITIES:
- Support unit operations described in standard operating procedures (100% of effort).
- Recognize and report deviations from procedures.
- Preparation of media and buffers
- Documentation of processing steps on batch records and other approved attachments.
- Ensure compliance with company quality systems, safety procedures, and other company policies.
- Area and equipment labeling and organization.
- Supplies and gowning stocking (inventory maintenance).
- Support operations such as filter integrity testing, operation of sterilizers, CIP and COP carts.
- Cleaning, assembly, sterilization, disassembly, and operation of processing equipment.
- Meet GMP regulations (ICH Q7A) as it applies to job function.
- Assist in Materials Control shipping and receiving.
- General inventory control/movement ensuring accuracy of data and related transactions.
- Other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Strong verbal and written communication skills.
- Ability to work in a fast-paced, dynamic environment, with limited supervision.
- Demonstrated ability to multi-task.
- Ability to communicate, read, and write legibly in English.
- Strong computer skills sufficient to read and write email, review production schedules, read standard operating procedures.
- Ability to be a team player who would demonstrate reliability and responsibility.
- Detail oriented with the ability to complete written and verbally assigned tasks following specific procedures.
- Ability to interact constructively with peers and support groups.
- Due to the nature of manufacturing, shifts can and will vary. Shift preference may not always be available upon request.
EDUCATION/EXPERIENCE:
- High School Diploma or GED required
- Depending on level, 1-8 years of relevant experience (GMP operations, Bioprocessing awareness, facility sanitization, cleaning, assembly, sterilization, and operation of primary process equipment). Compensation is commensurate with experience
- Equivalent education and experience may substitute for stated requirements.
COMPENSATION RANGE:
$20.07 - $35.91 per hour