660 Forbes Blvd., SSF06
South San Francisco,
Industry: Clinical & Scientific
Job Number: 16113
Bayside Solutions is seeking a Validation Engineer I to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
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.
Validation Engineer I
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- This position is for a Validation Contractor for the Technology Validation group in South San Francisco Production (SSFP).
- The candidate will be responsible for supporting validation activities.
- This includes supporting Periodic Reviews of validated equipment in SSFP, which entails review of change records for validation impact, through the TrackWise system.
- The Periodic Review will also include review of monitoring data trends and validation lifecycle documents.
- These reviews will be compiled in a Periodic Review summary report.
- The contractor may support revalidation execution on equipment to ensure the equipment has been operating in a validated state, Cleaning Validation activities, New Product Introduction (NPI), and qualification of changes to GMP equipment.
- Activities may include but are not limited to protocol generation, execution of protocols, swab and rinse water sampling, data analysis, reviewing worksheets, obtaining batch records and QC results, and summary report authoring.
- The contractor will be expected to work effectively with customers (System Owner and Technical SME and Quality) to complete these validation activities.
- Contractor must follow all safe work practices including use of appropriate Personal Protective Equipment and ensure training is up to date.
Summary of Qualifications:
- B.S. in Chemical, Biochemical or Mechanical Engineering or Science discipline with 0-3 years of relevant experience.
- The candidate must be highly self-motivated, have excellent organization and communication skills, be willing and able to work independently or as part of a multi-disciplinary team.
- Attention to detail is essential for a successful candidate. Standard work hours are Monday through Friday day shift however weekend work or off hour work may be required.
- Experience in a GMP regulated environment and use of quality systems and processes such as change control and discrepancy / deviation processes is desirable, but not required.