Validation Engineer

Summary

Join Syner-G BioPharma Group and Sequoia Biotech Consulting, a leading life sciences consultancy, as a Validation Engineer. You will leverage your expertise in validation processes, quality systems, and regulatory compliance to ensure all equipment, systems, and processes meet required standards. This role demands a strong understanding of validation principles and cross-functional collaboration. You will develop and execute validation protocols, maintain quality systems, and lead change management strategies. The position offers a competitive salary, robust benefits, flexible work options, and career development opportunities. Syner-G BioPharma Group was recently recognized as a Best Place to Work, highlighting its commitment to employee well-being and growth.

Requirements

• Bachelor’s degree in Engineering, regulatory affairs, or a related field
• Minimum of 5-7 years of experience in validation engineering, with specific expertise in equipment, systems, and process validation
• Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to validation processes
• Proficiency with quality systems including change control and quality events
• Demonstrated success in managing multiple projects in parallel
• Excellent communication skills with the ability to work effectively across departments and influence stakeholders
• Strong project management skills, with the ability to manage multiple projects simultaneously
• Strong leadership and team management abilities
• Detail-oriented with strong analytical and problem-solving capabilities
• Ability to work in a fast-paced, dynamic environment

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes
• Maintain and enhance validation quality systems to ensure compliance with regulatory requirements (e.g., FDA, EMA)
• Develop and improve standard operating procedures (SOPs), work instructions, and quality documentation related to validation processes
• Lead and implement change management strategies to support product lifecycle changes and minimize operational impact
• Plan, execute, and oversee validation projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements
• Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross-functional teams
• Identify project risks and implement risk mitigation strategies including process improvements and regulatory compliance
• Analyze existing validation workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk
• Drive continuous improvement initiatives to streamline validation processes, enhancing compliance, productivity, and cost-effectiveness
• Provide technical expertise and troubleshooting support for validation-related issues, including root cause analysis and corrective action planning
• Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach
• Ensure that all validation specifications meet regulatory and process standards
• Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align validation strategies with overall business objectives
• Support product launches, updates, and regulatory requirements by coordinating with cross-functional teams to achieve timely and compliant product releases
• Facilitate team huddles and weekly planning meetings with cross-functional resources involved in the project, including teams both inside and outside of the CQV organization
• Coordinate work related to the CQV process during the design phase of greenfield builds
• Work closely with QA, QC, Automation, Engineering, Validation, CapEx, EH&S, Utilities startup group, and Upstream and Downstream Processing teams by running meetings and providing project oversight. Follow up on action items and deliverables
• Communicate and address timelines and delays with internal stakeholders
• Act as a support resource to the PM in handling coordination, tracking vendor status, tracking project status, validating user requirements, documentation, and meeting minutes
• Drive coordination of daily, weekly, and monthly activities for assigned areas, focusing on execution, staffing coordination, and area availability

Benefits

• Market competitive base salary and annual incentive plan
• Robust benefit offerings
• Ongoing recognition and career development opportunities
• Generous flexible paid time off program
• Company-paid holidays
• Flexible working hours
• Fully remote work options for most positions and the ability to work “almost anywhere”