BioPharma Consulting JAD Group is on the lookout for a dedicated Sr. Validation Scientist to join our innovative team.
This role is essential in ensuring that our validation processes meet the highest standards of quality and compliance within the biopharmaceutical industry.
The ideal candidate will lead validation projects from conception to implementation, ensuring alignment with regulatory requirements and internal guidelines.
Key Responsibilities: Troubleshooting and Validation: Troubleshoot systemic validation issues and apply advanced validation engineering principles to design and implement major system or process modifications and capital projects.
Project Management: Develop, organize, analyze, and present results for complex operational issues or validation engineering projects.
Work with project managers to complete validation responsibilities within schedule, budget, and quality constraints.
Technical Solutions: Develop technical solutions for complex problems using ingenuity and creativity.
Apply validation engineering expertise across various assignments and fields.
Policy Development: Develop and implement validation engineering policies and procedures affecting multiple organizational units.
Team Supervision: Supervise, coordinate, and review the work of a small team of engineers and/or technicians.
Develop departmental or project budgets encompassing multiple disciplines.
Collaboration: Work with manufacturing, process development, utilities, facilities, labs, and quality assurance to develop requirements and recommendations for process or system modifications.
Leadership and Liaison: Lead efforts within a group or project, represent the organization on technical matters, and interact with senior external personnel.
Regulatory Compliance: Understand and apply regulatory trends and requirements, including experience with FDA or equivalent regulatory bodies.
Endorse and implement validation programs and practices.
Skills: Ability to provide imaginative, thorough, and practicable solutions to complex problems.
In-depth knowledge of validation engineering, including project management and budget development.
Strong skills in schedule development, facilitation, collaboration, negotiation, and conflict resolution.
Ability to handle multiple projects and manage both internal and external resources effectively.
Proficiency in technical writing, communication, and leadership.
Requirements Education and Experience: Doctorate degree in Engineering or a related scientific field with 3 years of directly related experience, or Master's degree in Engineering or a related scientific field with 3 years of directly related experience, or Bachelor's degree in Engineering or a related scientific field 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 Qualifications: Engineering or scientific background (e.g., Biology, Microbiology, Biotechnology, Chemistry).
Previous experience in regulated environments (e.g., Biotechnology, Pharmaceutical, Medical Devices).
Experience in Process Validation within a regulated industry.
