Manufacturing Tech Specialist
Vacaville, CA | Contract
Bayside Solutions is seeking a Manufacturing Tech Specialist to be part of our client’ s team in Vacaville. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
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 Tech Specialist
- 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:
- Development, authorship, coordination, and/or execution of studies supporting process characterization/validation program.
- Sampling material from plant and coordinate analytical testing with SSF testing group.
- Alignment of process requirements documentation with manufacturing master batch records.
- Drafting, facilitation, and execution of process transfer related risk assessments.
- Perform data verification review for the assigned technical, process characterization, and process validation studies.
- Occasionally, this position may involve some work during non-business hours.
Summary of Qualifications:
- B.S./M.S./Ph.D. in Chemical/Biochemical Engineering or Biology/Biochemistry (or equivalent)
- The candidate must have work experience in a GMP regulated environment and an understanding of biopharmaceutical processes, equipment and facilities with demonstrated advanced knowledge of at least one biopharmaceutical unit operation or aspect of Validation.
- Knowledge and application of basic validation and risk management theories, principles and techniques used in biopharmaceutical manufacturing is highly desirable.
- Previous experience on executing process validation is a plus.
- Highly self-motivated and able to work independently and as part of a multi-disciplinary team.
- Outstanding attention-to-detail, time management, prioritization, and organizational skills
- Solid interpersonal, communication, and technical writing skills.
- Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.