Validation Engineer

Overview

CAI is a global professional services firm founded in 1996 with nearly 700 employees focused on providing commissioning, qualification, validation, startup, project management, and consulting services for life sciences and other mission-critical sectors regulated by the FDA and similar authorities. Our core mission is to serve clients as trusted partners dedicated to advancing a better working world and improving human experiences. We operate with integrity, mutual support, societal service, and future orientation as foundational principles. CAI embraces innovation and excellence, constantly challenging industry norms through a blend of expertise, technology, and human insight to ensure operational readiness not just as a goal but a way of life.

Job Summary

The Validation Engineer role involves leading commissioning, qualification, and validation efforts specifically for packaging and combination product assembly lines. The position demands adherence to GMP, strict data integrity standards, and regulatory compliance. Responsibilities include developing and executing validation protocols, managing related documentation, coordinating necessary resources, and ensuring timely delivery of CQV activities. Early involvement in project design, vendor interactions, risk mitigation, and partnership with cross-functional teams is essential to achieving high-quality, right-first-time results.

Key Responsibilities

• Direct comprehensive validation activities within GMP settings emphasizing safety, quality, and compliance.
• Plan and conduct qualification processes including FAT/SAT and commissioning, while managing deviations and CAPA procedures.
• Collaborate with engineering, operations, quality assurance, and IT teams to troubleshoot and resolve validation issues.
• Develop and assess validation documents such as Validation Master Plans, URS, IQ/OQ, Installation, Operational, and Performance Qualification protocols ensuring audit readiness and ALCOA+ compliance.
• Qualify packaging equipment including vial labellers, cartoners, labelling systems, vision inspection systems, printers, coders, and associated handling and inspection devices.
• Validate serialization and aggregation systems to ensure data accuracy and meet regulatory requirements.
• Support design reviews, shakedown, commissioning, FAT, IQ/OQ/PQ phases, and ensure alignment with project timelines.
• Lead vendor engagements during FAT/SAT to meet project goals and validate market-specific packaging formats addressing artwork, labelling content, pack configuration, tamper evidence, variable data, and serialization standards.
• Investigate deviations using root cause analysis techniques such as 5-Whys and fault tree analysis; implement corrective actions and timely CAPA closure while updating change controls.

Qualifications

• Bachelor’s degree in Engineering preferred; equivalent experience considered.
• 5 to 10 years of experience in validation within pharmaceutical or life sciences sectors.
• Expertise with packaging and inspection equipment plus serialization/aggregation technologies.
• Strong knowledge of GMP regulations and data integrity principles (ALCOA+).
• Experience with risk-based validation approaches and structured root cause analysis.
• Excellent organizational, planning, problem-solving, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Technical degree in Engineering is advantageous.

Leadership Competencies

• Ability to align team objectives with overall business strategies and balance short- and long-term goals.
• Understanding of financial and risk considerations, supporting continuous risk management initiatives.
• Fostering a customer-centric environment and anticipating customer needs.
• Maintaining accountability, encouraging managed risk-taking, and keeping teams focused on objectives.
• Effective collaboration and networking to influence and engage others positively.
• Supporting talent development, diversity, inclusion, and promoting continuous learning.
• Championing ethical, safe, and inclusive workplace culture with integrity and leading by example.

Additional Information

CAI is an equal opportunity employer committed to veterans and workplace diversity. The job description is not exhaustive; additional duties may be assigned. The recruitment process may involve AI tools for application review and analysis, with human decision-making retained for final hiring choices.