Title: Manufacturing Associate
Account: BioMarin
Pay rate: flat $28 hour, depends on shift
Location: Navoto, CA
Environment: Clean room environment - must wear gown, hairnet etc, no makeup no jewelry
Shift work:
Alternating Sat and Sun-Tues 6pm to 7am
Sun-Tues/Weds 6am to 7pm
Sun-Thurs with alternating Saturdays 6pm to 7am
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.
QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.
WORK ENVIRONMENT/PHYSICAL DEMANDS
Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
May require work around loud equipment. - The use of personal protective equipment will be required.
Requires various shift based work and off hours.
Education
-Bachelor's degree in science related area or engineering
-Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
Nice to Have skills:
cGMP -Current Good Manufacturing Practices (cGMP) are regulations enforced by the FDA to ensure the quality, safety, and efficacy of products manufactured for human and animal use. They establish minimum requirements for the design, monitoring, and control of manufacturing processes, facilities, and operations. cGMPs are essential in various industries, including pharmaceuticals, biotechnology, and food, as they help maintain compliance with evolving standards and technologies. Key aspects of cGMP include:
Continuous Improvement: cGMPs require manufacturers to stay current with advancements in technology and practices.
1) Quality Management Systems: They emphasize the importance of strong quality management systems to prevent contamination and ensure product integrity.
2) Documentation and Traceability: cGMPs mandate thorough documentation to ensure traceability and accountability throughout the manufacturing process.
3) Risk-Based Controls: They focus on identifying potential product quality and safety issues before they impact product quality.
4) Adhering to cGMPs is crucial for ensuring that products meet quality standards and protect consumers' health and safety.
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