Overview
Sr Validation Scientist Jobs in Juncos, Puerto Rico at BioPharma Consulting JAD Group
Title: Sr Validation Scientist
Company: BioPharma Consulting JAD Group
Location: Juncos, Puerto Rico
We are seeking a highly skilled and independent Validation Engineer to provide technical support for process and equipment upgrades, replacements, and modifications in laboratory, manufacturing, or manufacturing support environments. The ideal candidate will possess advanced validation expertise and demonstrate exceptional problem-solving, leadership, and technical skills. This role involves ensuring the success of complex projects, driving innovative solutions, and serving as a technical expert for validation programs and practices.
Responsibilities
Troubleshoot systemic validation issues and apply advanced validation engineering principles to complex process or system modifications
Develop and implement validation engineering policies and procedures affecting multiple organizational units
Employ advanced validation techniques to create innovative solutions to technical problems
Assess, organize, analyze, and interpret results for operational issues or validation projects
Lead validation responsibilities for engineering projects while managing schedules, budgets, and quality constraints
Collaborate with cross-functional teams (manufacturing, utilities, facilities, labs, quality assurance) to establish requirements for system or process modifications
Supervise and coordinate the work of engineers and technicians on project or ongoing bases
Develop project budgets and monitor expenditures within the scope of the project
Represent the organization as the prime technical contact on contracts and validation projects
Interact with senior external personnel and regulatory bodies (e.g., FDA) to endorse and advance validation programs
Ensure alignment between industry regulatory trends and established corporate directions
Provide technical guidance and project leadership to teams, ensuring successful completion of broad programs
Delegate tasks effectively, develop schedules, and manage project resources to achieve objectives
Foster collaboration among internal and external stakeholders, including contractors and vendors
Provide expertise in equipment qualification, cleaning validation, sterilization, and process validation
Support validation responsibilities for new product introductions, optimization projects, and commercial manufacturing
Apply creative problem-solving skills and scientific principles to address technical challenges
Key Competencies And Skills
Advanced knowledge of validation processes and requirements, including equipment qualification and cleaning validation
Ability to lead and supervise project teams and manage technical resources effectively
Strong problem-solving abilities requiring application of scientific theories and engineering principles
Exceptional skills in negotiation, collaboration, project cost development, conflict resolution, leadership, and team building
Experience with project management tools and techniques
In-depth understanding of financial analysis tools
Requirements
Education and 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 Qualifications
Strong background in engineering (any field) or scientific disciplines such as Biology, Microbiology, Biotechnology, or Chemistry
Experience in regulated environments (Biotechnology, Pharmaceutical, Medical Devices) with emphasis on validation processes (preferably process validation)
