Manufacturing Technician I
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Manufacturing Technician I to be part of our client’ s team in Vacaville. 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.
Manufacturing Technician 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:
- Provide support to the crenezumab tech transfer project to enable completion of process validation and health authorities submission technical packages.
- Develop and execute logistics for analytical data supportive of technical and process validation studies.
- This includes: coordination with Manufacturing, Process Engineering, Quality Control, and Process Technical Development on non-routine sampling request, sample aliquoting, sample shipment, testing lab coordination, and test results compilation.
- Collaborate with Process Engineering and Quality Assurance to translate qualification runs batch genealogy into run context.
- Develop and execute translation of electronic batch records into process summary.
- Perform data verification of translated information from electronic batch records into process summary.
- Prepare technical package for data summary and supportive information to support conclusion of technical and process validation studies.
- Provide support on technical documentation logistics.
- Creates and maintains dashboard communication and visual management strategies to track activities assigned for ease of reporting to project lead(s).
- Occasionally, the position may involve some work during non-business hours.
Summary of Qualifications:
- 0-2 years of related experience, preferably in the B.S./M.S./Ph.D. in Chemical/Biochemical Engineering, or other Engineering/Life Sciences majors.
- Solid understanding of basic engineering techniques and principles, and the ability to apply that knowledge.
- Must be able to clearly communicate information to a varied audience and good technical writing skills.
- Effective communication and interpersonal skills with technical, operations, quality personnel as well as project/process engineering personnel.
- Thorough understanding and application of cGMP’ s particularly as they relate to the Good Documentation Practices (GDP).
- Outstanding organization and attention to detail.
- Ability to adapt to changing priorities.
- Ability to work independently, seek stakeholders input, and drive assignments to completion.
- Knowledge or previous experience on monoclonal antibody production processes and statistics (including the use of statistical software such as JMP) is highly desirable.