Bend, Oregon /
Manufacturing Science and Technology – Systems Qualification /
Serán seeks Validation Engineers to join our Manufacturing Science and Technology group at Serán BioScience. Validation is a regulatory requirement and must be conducted in conformance to cGMPs and FDA requirements. The Validation Engineer will be part of a cross functional team that will develop and execute validation studies for process, cleaning, computerized systems, and qualification of equipment and critical utilities needed to support clinical and commercial distribution of sterile and non-sterile pharmaceutical products.
Under the supervision of the MS&T Leadership, the Validation Engineer will be responsible for development and execution of validation studies, which requires 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.
The development and execution of validation studies requires direct communication with internal and external cross functional teams. Effective communication is essential for extracting required information, alignment of strategies and approaches, and correcting deficiencies while maintaining good working relationships.
Duties and Responsibilities
- Lead cross functional internal and external teams during execution of validation projects
- Assist MS&T Leadership in developing validation programs to support projects for new product introduction, tech transfer, product / process optimization in the Clinical and Commercial Manufacturing facility for sterile and non-sterile products
- Maintain the validation programs in conformance with all applicable guidelines, policies, procedures, and requirements.
- Author validation protocols and reports
- Coordinate training and execution of validation studies
- Work 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
- Assist MSAT Leadership in managing project budgets
- Performs other related duties as assigned
Required Skills and Abilities
- Knowledge of cGMP guidelines and regulations acquired through education, experience, and training. Additional knowledge of Global Regulatory requirements will be desirable (E.g., FDA / MHRA / EMEA)
- Basic understanding of the Compliance and Technical requirements on the application of various scientific concepts used for developing different dosage forms of pharmaceutical products (primarily oral solid dose and some knowledge and experience with sterile products are desired)
- Knowledge of Regulatory expectations and Industry practices for Validation using Product Lifecycle approach
- Effective written, oral, and interpersonal communication skills
- Demonstrate leadership skills with ability to motivate and coach cross functional teams
- Strong time-management skills and the ability to organize and coordinate multiple projects at once
- Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
Education and Experience
- Bachelor's degree in relevant field with 2 years of relevant experience or 5 years of equivalent technical and quality experience in clinical and commercial pharmaceutical manufacturing
- Fundamental understanding of validated computer systems, equipment, utilities, process, cleaning and change management in the pharmaceutical/biotech industry
- GMP compliance knowledge including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others
- Level and compensation will be commensurate with education and experience
- Prolonged periods of sitting at a desk and working on a computer
- Prolonged periods of sitting or standing in a manufacturing environment
- Must be able to lift fifteen pounds at times