Validation Engineer

Accountabilities:: Lead the preparation and execution of validation lifecycle documentation, including FAT, SAT, IQ, OQ, and PQ, for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP-regulated assets. Oversee validation activities for internal and client technology-transfer projects, including authoring, executing, reviewing, and closing risk assessments, validation plans, protocols, test methods, and final reports. Write, review, and update qualification and verification documentation, including SOPs, validation master plans, execution plans, user and functional requirements specifications, design specifications, FAT documents, verification protocols, and commissioning procedures. Prepare comprehensive summary reports covering validation, verification, commissioning, and requalification activities. Develop and support procedures, investigations, protocols, reports, and change controls in collaboration with Maintenance, Engineering, and Quality teams. Lead P&ID walkdowns to verify system installation, configuration, and readiness. Perform and oversee thermal mapping activities for temperature-controlled chambers, warehouses, and SIP processes. Support the investigation and resolution of regulatory observations, audit findings, and manufacturing site issues related to validation. Lead periodic reviews and requalification activities for temperature-controlled systems and other validated assets. Provide technical guidance and mentorship to junior validation engineers and contribute to team development. Coordinate cross-functional validation activities to ensure alignment with project timelines, operational requirements, and quality expectations. Requirements: Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline. 7–11 years of experience in the biotechnology, pharmaceutical, or medical device industry. Strong understanding of FDA current Good Manufacturing Practices (cGMP), Failure Mode and Effects Analysis (FMEA), and risk-based validation principles. Advanced expertise in equipment validation, computerized systems validation (CSV), analytical methods, and process validation. Extensive experience developing protocols for automated production systems, particularly computerized equipment and systems. Demonstrated ability to author and review IQ, OQ, PQ, and CSV documentation and reports. Experience supporting regulatory inspections, audits, remediation activities, and the resolution of compliance findings. Strong written and verbal communication skills, with the ability to explain complex technical topics to diverse stakeholders. Excellent organizational, analytical, and documentation skills, with the ability to manage multiple priorities independently. Strong problem-solving capabilities, including experience supporting investigations and root-cause analysis. Proven ability to lead validation workstreams, collaborate across functions, and mentor junior team members. Ability to meet the role’s physical requirements, including regular computer use, walking and sitting, and occasionally lifting or carrying items weighing up to 25 pounds. Must be currently authorized to work in the United States, as employment visa sponsorship is not available. Benefits: Annual base salary range of $110,000–$125,000 , depending on experience, qualifications, geographic location, and other job-related factors. Annual incentive plan. Comprehensive benefits package. Flexible paid time off and company-paid holidays. Flexible working hours. Fully remote work options for most positions, with the flexibility to work from various locations. Office locations available in Greater Boston, San Diego, Boulder, and India. Ongoing professional development, career growth, and learning opportunities. Employee recognition programs and a culture focused on collaboration, innovation, and individual contributions.