Validation Engineer II

Responsibilities

• Lead validation impact assessments and provide technical oversight for change management activities involving facilities, utilities, systems, equipment, computerized systems, and manufacturing processes.
• Develop and support site-wide Validation and Commissioning & Qualification (C&Q) programs, including Validation Master Plans, validation strategies, and risk-based approaches to ensure regulatory compliance.
• Independently lead complex validation projects including commissioning, qualification, requalification, process validation, and technology transfer activities with minimal supervision.
• Serve as the Validation Subject Matter Expert (SME) for design reviews, change controls, risk assessments, investigations, deviations, CAPAs, and capital projects.
• Lead cross-functional project teams by coordinating validation deliverables, influencing technical decisions, managing timelines, and ensuring compliance objectives are achieved.
• Author, review, approve, and execute validation lifecycle documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, Process Validation protocols, Summary Reports, and Traceability Matrices.
• Direct commissioning, qualification, and periodic review activities for GMP facilities, cleanrooms, utilities, temperature-controlled environments, laboratory equipment, sterilization systems, hot cells, and computerized systems.
• Provide technical guidance for process development, cleaning validation, process validation, method validation, cycle development, and commercial manufacturing operations.
• Support regulatory inspections and audits by serving as a validation representative, addressing observations, and ensuring timely implementation of corrective and preventive actions.
• Drive continuous improvement of validation systems and standards through development of procedures, training programs, templates, best practices, and initiatives that enhance compliance, efficiency, and inspection readiness.

Early Development

After 3 months you will: Develop a strong understanding of NorthStar’s validation lifecycle and quality systems, including validation procedures, commissioning and qualification practices, change control processes, and regulatory expectations. Support validation and qualification activities by assisting with protocol development, execution, documentation review, impact assessments, and validation deliverables under the guidance of senior team members. Build relationships with cross-functional stakeholders while contributing to project teams, learning site systems and processes, and developing the technical expertise needed to independently lead validation activities.

After 6 months you will: Lead routine validation and qualification activities with limited oversight, including protocol development, execution, impact assessments, change controls, and validation documentation for assigned systems and projects. Serve as a trusted validation resource for cross-functional teams, providing technical input on commissioning, qualification, process validation, investigations, deviations, and risk assessments while building subject matter expertise. Drive compliance and continuous improvement initiatives by supporting audit readiness, improving validation processes and templates, and ensuring validation activities are executed in accordance with regulatory and company requirements.

Qualifications

• Bachelor’s degree in Engineering or a Science related field with minimum four (4) years of progressive experience in the pharmaceutical industry acting in a Qualification/Validation role; or equivalent combination of education and experience.
• Experience working with current validation principles, standard concepts, practices and procedures, and requirements in a cGMP regulated environment is necessary.
• Demonstrated proficiency in three or more validation areas required.
• Experience in the following areas is preferred: Facility and cleanroom qualification, Equipment qualification, Computer System Validation (CSV), Utility qualification, Process validation, Cleaning validation, Technology transfer, Method validation.
• Experience supporting commercial manufacturing operations and technology transfers.
• Experience using statistical tools and data analysis techniques for validation activities.