1360 OâBrien Drive Menlo Park, CA 94025
Bayside Solutions is seeking a Technical Writer to be part of our client’ s team in Menlo Park that will be relocating to Fremont within the following year. This is an opportunity to work with a fully integrated commercial-stage biopharmaceutical company.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Reporting to: Senior Engineer, Engineer & Validation
Writing technical documents, such as but not limited to standard operating procedures (SOPs), manufacturing, and analytical procedures, CQV procedures, protocols and reports for a GxP regulated environment. Work closely with Quality Assurance (QA) Document Control group for document number assignment, filing, and maintenance. Must be able to interact cross-functionally with internal groups, contract manufacturing organizations (CMOs), collaborators, and business partners to ensure required information is accessible and organized. Other technical document related tasks may be assigned.
The ideal candidate for this position will have a proven track record of authoring technical documents in a GxP environment for fast-paced engineering and CQV CapEx projects and may have a deep understanding of ASTM, ICH, 21CFR Part 11/210/211/820 guidelines.
Education & Skills
- A minimum BS degree, or equivalent, in technical discipline (engineering or sciences) and 8 years of relevant biotechnology or pharmaceutical industry experience
- Familiarity with process engineering, plant engineering and CQV procedures
- General knowledge of current Good Manufacturing Practices (FDA, EMEA, and ICH guidance)
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint), Microsoft Visio, and Adobe Acrobat Professional
- Direct knowledge of manufacturing processes, engineering and validation lifecycle a plus
- Familiarity with MasterControl a plus