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.

Duties and Responsibilities

• Leads the commissioning and qualification (C&Q) of new and existing equipment and systems for OSD manufacturing, facilities, and utilities, ensuring compliance with cGMP, FDA, and EU regulatory standards
• Supports the clinical technology transfer and operations in design, scale-up, optimization, and troubleshooting of OSD processes and equipment
• Develops and executes protocols for equipment IQ/OQ/PQ in alignment with site validation master plans and project timelines
• Collaborates with cross-functional teams to define equipment specifications, user requirements (URS), and establish project timelines and budgets
• Manages installation activities, equipment FAT/SAT execution, and vendor coordination to ensure technical and compliance requirements are met
• Collaborates with multidisciplinary team to complete change controls, deviations investigations, and CAPAs as required
• Supports regulatory inspections and client audits
• 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
• Preference for those who posses knowledge of Global Regulatory requirements (E.g., FDA / MHRA / EMEA)