Serán 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
- Demonstrates knowledge of cGMPs guidelines and regulations acquired through education, experience, and training; additional knowledge of Global Regulatory requirements (E.g., FDA / MHRA / EMEA) are preferred
- Showcases foundational understanding of the compliance and technical requirements for the application of various scientific concepts used in developing different dosage forms of pharmaceutical products (primarily oral solid dose, while experience with sterile products is desired)
- Experience with regulatory expectations and industry practices for CQ and Validation using Product Lifecycle approach
- Experience with designing CQV plans for critical utilities; HVAC, OSD manufacturing equipment including process automation and CIP systems
- Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team
- Strong time-management skills and the ability to organize and coordinate multiple projects at a time
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
- Ability to prioritize tasks and to keep leadership apprised of performance to timelines
- Accepts feedback from a variety of sources and constructively manages conflict
- Demonstrate leadership skills with ability to motivate and coach cross functional teams
- Strong time/project management skills and the ability to organize and coordinate multiple projects at once
- Experience in FAT/SAT and operating principles of typical OSD process equipment
- 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 technical field
- Requires a minimum of 5 years of quality, validation, or engineering experience in non-sterile clinical and commercial pharmaceutical manufacturing
- Fundamental understanding of process equipment, utilities, manufacturing process, cleaning process and Quality systems used in the pharmaceutical/biotech industry
- 5 years of GMP compliance experience, including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others
Physical Requirements
- Prolonged periods of sitting or standing 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
- Adheres to consistent and predictable in-person attendance