We are seeking an experienced Senior Validation Engineer. Our ideal candidate is a versatile engineering professional, with superior skills and experience in the optimization of procedure improvement and a willingness to work in a dynamic, on-site pharmaceutical project environment.

Job Responsibilities:

• Develop and execute validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment.
• Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
• Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
• Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
• Responsible for vision systems equipment specification development.
• Provide input to user requirements, design specifications, process parameters, and FMEA assessments.
• Independently execute, and direct others in the execution of, the design of processes and equipment by applying novel engineering concepts and techniques within the discipline.
• Identify new technologies for vision equipment, including implementation of AI. Design and conduct testing to evaluate these new technologies and equipment changes as part of the technical roadmap.

Job Requirements:

• A bachelor’s degree in computer, electrical, mechanical, or related Engineering Area.
• Minimum of 10 years relevant experience as a Process Engineer.
• Minimum 10 years of experience working in a GMP environment.
• More than five years of experience working with manual, Semi Automated and Automated Vision equipment.
• More than five years of experience working with Aseptic Filling, Freeze Drying, and Clinical Packaging Operations would be preferred.
• A technical and regulatory background in vision systems in the pharmaceutical industry.
• Experience in large capital/expansion programs with direct design responsibility.