Contract Technical Writer Jobs in Santa Rosa, CA

Description
Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs 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 ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
CONTRACT ROLE MULTIPLE OPENINGS
Schedule is Sun-Tues/Alternating Wednesdays 6AM to 7pm
Duties
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.
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
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
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Ireland Safety Responsibility Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.