Senior Validation Engineer I

Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience).

Knowledge of validation principles across multiple disciplines, which may include process validation, aseptic process simulation, equipment qualification, and/or computer systems.

Significant experience in process validation within the pharmaceutical or biotechnology industry.

Strong understanding of Quality by Design (QbD) principles with proficiency in risk assessment methodologies (e.g., PFMEA) and statistical analysis tools for validation data (e.g., Minitab, JMP).

Strong understanding of cGMPs (current Good Manufacturing Practices).

Excellent analytical, problem-solving, and decision-making skills, with meticulous attention to detail.

We are currently looking for a highly skilled and experienced

Senior Validation Engineer I

to join the Forge Biologics team. As a Sr. Validation Engineer I, you will be responsible for the design, implementation, and execution of process validation activities to ensure the compliance, quality, and efficacy of our manufacturing processes. You will work closely with cross-functional teams to develop and execute validation strategies, provide technical expertise in process validation and aseptic process simulation to ensure adherence to regulatory compliance and industry best practices.

Develop, Implement, and Maintain the Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs, including development of related procedures, templates, work instructions, and associated documentation.

Develop and lead execution of Process Performance Qualification (PPQ) protocols, for GMP manufacturing processes.