Summary: We are seeking a highly skilled and experienced Senior Validation Scientist to provide technical validation engineering support for process and/or equipment upgrades, replacements, and modifications within laboratory, manufacturing, or manufacturing support environments.
The ideal candidate will have advanced validation knowledge, strong problem-solving skills, and experience leading projects in a regulated industry.
Responsibilities: Troubleshoot systemic validation issues and apply advanced validation engineering principles to major system or process modifications and capital projects.
Develop, organize, and analyze results for complex validation engineering projects, ensuring successful execution of validation protocols and reports.
Develop and improve validation engineering techniques, policies, and procedures.
Supervise and guide a small team of engineers and technicians, providing oversight for ongoing and project-based work.
Provide technical solutions to complex validation problems using ingenuity and creativity.
Work closely with manufacturing, process development, utilities, facilities, labs, and quality assurance to develop requirements and recommendations for large-scale process and system modifications.
Manage the validation responsibilities of engineering projects, ensuring they are completed on schedule, within budget, and in compliance with quality standards.
Develop departmental or project budgets, encompassing multiple disciplines.
Ensure prompt and regular attendance to the workplace.
Skills: Expertise in equipment qualification, cleaning, and sterilization processes.
Ability to provide innovative, thorough, and practical solutions to difficult technical problems.
Lead efforts of a group of peers, supervise staff or project resources, and ensure the successful completion of major programs.
Represent the organization as the primary technical contact on contracts and projects, coordinating with senior external personnel.
Understand regulatory trends in the industry and apply them to organizational direction, with experience interacting with FDA or equivalent regulatory bodies.
Ability to handle multiple projects simultaneously, with a focus on schedule development, collaboration, and cost management.
In-depth knowledge of validation processes and requirements.
Ability to manage projects, delegate work, and oversee contractors and vendors.
Effective interaction with diverse communication styles and ability to collaborate and facilitate cross-functional teams.
Strong problem-solving skills and the ability to make decisions based on scientific and engineering principles.
Requirements Education/Experience: Doctorate degree or Master's degree with 3 years of directly related experience, or Bachelor's degree with 5 years of directly related experience, or Associate's degree with 10 years of directly related experience, or High school diploma/GED with 12 years of directly related experience.
Preferred Experience: Experience in URS, DS, and Equipment Risk Assessments.
Experience in characterization and validation, including the development and execution of protocols and reports.
Hands-on experience in device assembly equipment and packaging equipment validation.