Sr Validation Scientist

BioPharma Consulting JAD Group

About The Position

The Senior Validation Engineer independently provides and/or directs technical validation engineering support for process and equipment upgrades, replacements, and modifications within laboratory, manufacturing, and manufacturing support environments. This role applies advanced validation engineering principles to complex systems and capital projects, ensuring compliance with regulatory requirements and alignment with organizational objectives. The position may include leadership responsibilities and direct supervision of validation personnel. Key Responsibilities Troubleshoot complex and systemic validation issues. Design and implement validation strategies for major system or process modifications. Develop and execute validation protocols and reports. Apply advanced validation techniques to equipment qualification, cleaning validation, sterilization validation, and aseptic processes. Develop new or improved validation engineering procedures and policies impacting multiple organizational units. Analyze, interpret, and present validation data for projects of significant scope and complexity. Execute validation activities inside cleanroom environments. Support validation activities in parenteral manufacturing environments. Lead or support Aseptic Process Validation (APV). Support Environmental Monitoring Performance Qualifications (EMPQ). Conduct Environmental Characterizations. Perform Airflow Visualization (Smoke Studies). Ensure compliance with cGMP and regulatory standards. Collaborate with Manufacturing, Process Development, Utilities, Facilities, Laboratories, and Quality Assurance to define validation requirements. Partner with Project Managers to ensure validation deliverables are completed within schedule, budget, and quality constraints. Develop project budgets or departmental budgets for validation scope. Lead project teams and supervise engineers and/or technicians. Delegate work and manage contractor activities as needed. Represent the organization as the primary technical contact for validation programs. Maintain strong knowledge of regulatory expectations and industry trends. Support regulatory inspections and audits (FDA or equivalent). Represent validation programs and practices to regulatory bodies when required. Ensure validation activities align with corporate and regulatory direction. Advanced knowledge of validation processes including: Equipment Qualification (IQ/OQ/PQ) Cleaning Validation Sterilization Validation Strong understanding of cGMP regulations. Broad technical knowledge across related engineering disciplines. Working knowledge of financial analysis tools and project budgeting. Ability to develop creative and technically sound solutions to complex validation challenges. Apply scientific and engineering principles to solve moderate to highly complex technical issues. Independently determine when additional internal or external resources are required. Ability to supervise staff and lead cross-functional project teams. Experience in schedule development, facilitation, and collaboration. Basic to advanced project management skills. Ability to manage multiple projects simultaneously. Strong delegation, contractor management, and follow-up skills. Demonstrated leadership, negotiation, and conflict resolution abilities. Effective interaction across diverse communication and working styles. Strong persuasion, facilitation, and decision-making skills. Ability to represent the organization as a technical expert internally and externally.

Requirements

Advanced knowledge of validation processes including: Equipment Qualification (IQ/OQ/PQ) Cleaning Validation Sterilization Validation
Strong understanding of cGMP regulations.
Broad technical knowledge across related engineering disciplines.
Working knowledge of financial analysis tools and project budgeting.
Ability to develop creative and technically sound solutions to complex validation challenges.
Apply scientific and engineering principles to solve moderate to highly complex technical issues.
Independently determine when additional internal or external resources are required.
Ability to supervise staff and lead cross-functional project teams.
Experience in schedule development, facilitation, and collaboration.
Basic to advanced project management skills.
Ability to manage multiple projects simultaneously.
Strong delegation, contractor management, and follow-up skills.
Demonstrated leadership, negotiation, and conflict resolution abilities.
Effective interaction across diverse communication and working styles.
Strong persuasion, facilitation, and decision-making skills.
Ability to represent the organization as a technical expert internally and externally.
Doctorate OR Master’s degree + 2 years of directly related experience OR Bachelor’s degree + 4 years of directly related experience OR Associate’s degree + 8 years of directly related experience OR High School Diploma/GED + 10 years of directly related experience

Nice To Haves

Validation experience in Parenteral Manufacturing environments.
Hands-on experience in: Aseptic Process Validation Aseptic Techniques Environmental Monitoring Performance Qualifications Environmental Characterizations Airflow Visualization (Smoke Studies)
Experience writing validation protocols and reports.
Experience executing validation activities in cleanroom environments.
Direct interaction with FDA or equivalent regulatory agencies.

Responsibilities

Troubleshoot complex and systemic validation issues.
Design and implement validation strategies for major system or process modifications.
Develop and execute validation protocols and reports.
Apply advanced validation techniques to equipment qualification, cleaning validation, sterilization validation, and aseptic processes.
Develop new or improved validation engineering procedures and policies impacting multiple organizational units.
Analyze, interpret, and present validation data for projects of significant scope and complexity.
Execute validation activities inside cleanroom environments.
Support validation activities in parenteral manufacturing environments.
Lead or support Aseptic Process Validation (APV).
Support Environmental Monitoring Performance Qualifications (EMPQ).
Conduct Environmental Characterizations.
Perform Airflow Visualization (Smoke Studies).
Ensure compliance with cGMP and regulatory standards.
Collaborate with Manufacturing, Process Development, Utilities, Facilities, Laboratories, and Quality Assurance to define validation requirements.
Partner with Project Managers to ensure validation deliverables are completed within schedule, budget, and quality constraints.
Develop project budgets or departmental budgets for validation scope.
Lead project teams and supervise engineers and/or technicians.
Delegate work and manage contractor activities as needed.
Represent the organization as the primary technical contact for validation programs.
Maintain strong knowledge of regulatory expectations and industry trends.
Support regulatory inspections and audits (FDA or equivalent).
Represent validation programs and practices to regulatory bodies when required.
Ensure validation activities align with corporate and regulatory direction.