(CW) Manufacturing Associate (Temporary/Contract) Night Shift

About Technical Operations

BioMarin's Technical Operations group is responsible for creating drugs for use in clinical trials and for scaling production for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to meet regulatory standards, and procure goods and services to support manufacturing and coordinate worldwide movement of drugs to patients.

Responsibilities

• Understand process theory and equipment operation; 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.)
• Provide feedback and/or suggested changes to operational procedures
• Assist in incorporation of new technologies, practices, and standards into procedures
• Write and review process documents
• Understand cGMPs as related to Commercial Operations
• Utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
• Participate on projects and contribute to outcomes
• 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 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.

Skills

• Strong communication skills—verbal and written
• Ability to work in a team environment which includes good conflict resolution and collaboration
• Displays good initiative to identify areas for improvement and implement solutions

Qualifications

• 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