What are the responsibilities and job description for the Validation Engineer, Commercial Operations position at Sern BioScience?
Sern BioScience is motivated to find an industry-experienced Validation Engineer to support the development of a new commercial manufacturing facility. Validation is a regulatory requirement and must be conducted in conformance to cGMPs and FDA requirements. The Validation Engineer for commercial manufacturing operations will be part of a cross functional team that will develop and execute commissioning / qualification (CQ) studies for equipment and critical utilities process, tech transfer of manufacturing process from clinical to commercial site, and subsequent validation for process, cleaning, and computerized systems to support commercial distribution of non-sterile pharmaceutical products.
Under the supervision of Commercial Leadership, the Validation Engineer will be responsible for development and execution of CQ and validation studies. In order to perform this task, applicants require a thorough understanding of the processes and systems to be studied as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements. Successful candidates will understand that the development and execution of CQ and validation studies requires direct communication with internal and external cross functional teams. Demonstrated ability with effective communication is essential for collecting required information, alignment of strategies and approaches, and correcting deficiencies while maintaining good working relationships.
Duties and Responsibilities
- Supports Commercial Leadership in developing CQ and validation programs to support projects for new product introduction, tech transfer, product / process optimization in the Commercial Manufacturing facility for non-sterile pharmaceutical products
- Leads cross functional internal and external teams during execution of CQ and validation projects for the commercial facility including equipment, facility / utility systems and control systems
- Oversees the external commissioning of resources
- Maintains the CQ and validation programs in conformance with all applicable guidelines, policies, procedures, and requirements
- Ensures that CQ and validation programs for commercial are harmonized with the clinical CQ programs in place
- Authors CQ and validation protocols and reports
- Coordinates training and execution of validation studies
- Works with internal and external teams to enhance current Quality and Technical systems supporting product development projects transitioning from Phase 2 / 3 clinical to registration as part of technology transfer and using Product Lifecycle concepts
- Assists Commercial Leadership in managing project budgets
- Performs other related duties as assigned
- Responsibilities may increase in scope to align with company initiatives
Required Skills and Abilities
Education and Experience
Physical Requirements
Visit https : / / www.seranbio.com / careers to learn more about company culture and the community of Bend, Oregon.
Level and compensation will be based on experience.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary :
Sern employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Sern covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.
The Corporate Headquarters of Sern BioScience are located at 63047 Layton Ave, Bend, OR 97701
