Senior Validation Engineer

Serán BioScience is motivated to find an industry-experienced Validation Engineer to support the development of a new commercial manufacturing facility. The Senior Validation Engineer will be part of a cross functional team that will plan and execute commissioning/qualification (CQ) projects 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. Experience will determine title and salary, with preference given to applicants with over 8 years of experience with Oral Solid Dosage and an interest in leading teams. Those with less experience are encouraged to apply.

 

As a critical member of the Commercial Steering Committee, the Senior Validation Engineer will be responsible for planning and execution of CQ and validation projects. In order to perform this task, applicants require a thorough understanding of the manufacturing processes and systems 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 projects requires communication with internal and external cross functional teams. Demonstrated ability with effective communication is essential for identifying required information, alignment of strategies, and mitigation risks while maintaining good working relationships.