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We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World.

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

Position Summary

Reporting to the Validation Senior Manager, the Validation Engineer (Manager, Validation) plays a key role in supporting LOTTE Biologics’ mission as a Contract Development and Manufacturing Organization (CDMO) by ensuring robust and compliant validation of equipment, utilities, and facilities across multiple client programs.

This role partners cross-functionally with Manufacturing, Quality, Engineering, and other departments to plan, manage, and execute commissioning, qualification, and validation activities. The individual will be responsible for developing and executing validation deliverables for new and existing equipment, supporting validation master and project plans, and driving process and project improvements that enhance reliability, compliance, and efficiency.

The Validation Engineer (Manager, Validation) may also provide day-to-day coaching and technical guidance to junior team members and contractors during qualification activities, ensuring adherence to validation standards and best practices.

Duties & Responsibilities

+ Develop and execute validation protocols, field activities, and final reports for, but not limited to:

+ Equipment, utility, and facility system qualifications

+ Requalifications and in-process equipment

+ Airflow visualization studies and temperature mapping

+ Utility sampling and steaming process equipment and autoclaves

+ Lead and document validation activities in compliance with current Good Manufacturing Practices (cGMPs), LOTTE directives, and applicable regulatory expectations.

+ Investigate process and quality issues, determine root causes, and implement effective corrective and preventive actions.

+ Identify and define process improvement and project optimization opportunities to enhance quality and efficiency.

+ Develop project plans, schedules, and timelines; monitor progress and ensure milestone completion.

+ Collaborate across functional teams to align validation activities with manufacturing and quality objectives.

+ Communicate project status, risks, and outcomes effectively to stakeholders and management.

+ Ensure validation and project documentation is accurate, complete, and compliant with data integrity and GDP standards.

+ Maintain a safe working environment and follow all company safety policies and procedures.

+ Operate equipment to perform operational qualifications and thermal mapping as required.

+ Record and review data following Good Documentation Practices (GDP).

+ Conduct investigations and support CAPA implementation as required.

+ Author and revise SOPs, training materials, and change control documentation related to validation activities.

+ Serve as a Validation Subject Matter Expert (SME) during regulatory and client audits and support timely resolution of audit findings.

+ Evaluate and assess change control requests in accordance with validation procedures and recommend appropriate actions.

+ Maintain current knowledge of LOTTE directives, industry standards, and global regulatory guidance related to validation.

+ Act as the Validation Services designee when qualified and assigned.

+ Support Validation department activities related to documentation storage, database management, and continuous improvement of validation processes.

Education & Experience

+ Bachelor’s degree in Engineering, Chemistry, Biological Sciences, or a related technical discipline, with relevant validation experience in the biopharmaceutical or pharmaceutical industry; or

+ Associate’s degree in a technical field with direct validation experience in a cGMP-regulated biopharmaceutical environment.

+ Minimum of 5 years of hands-on validation experience in a regulated pharmaceutical, biotechnology, or medical device environment, with demonstrated knowledge of GMP operations and equipment qualification.

+ Preferred 7–10 years of progressive experience in the pharma/biotech industry, including exposure to GMP manufacturing operations and increasing responsibility in equipment and utilities qualification, project leadership, and protocol authorship.

Knowledge, Skills, Abilities

+ Comprehensive understanding of equipment, utility, and facility qualification principles within a cGMP biopharmaceutical or CDMO environment.

+ Strong knowledge of validation lifecycle concepts, including risk-based and science-based approaches (e.g., ASTM E2500).

+ Familiarity with regulatory and industry guidance (FDA, EMA, ICH Q7/Q9/Q10, ISPE Baseline Guides).

+ Experience supporting regulatory and client audits, including presenting validation data and documentation.

+ Ability to manage multiple concurrent validation projects while maintaining quality and compliance.

+ Proficiency in authoring and reviewing validation protocols, reports, and SOPs with a focus on accuracy, clarity, and data integrity.

+ Strong analytical and problem-solving skills with the ability to interpret data and apply sound technical judgment.

+ Excellent communication, collaboration, and project management skills to effectively engage cross-functional teams.

+ Working knowledge of Lean or continuous improvement methodologies is a plus.

+ Familiarity with single-use technologies, biologics manufacturing equipment, and clean utility systems preferred.

+ Proficiency with validation documentation systems and change control workflows.

+ Professional demeanor and technical competency to represent the department before regulatory authorities, clients, and internal leadership.

Physical Demands

This position is primarily office-based but requires routine entry into laboratories and manufacturing areas to access instrumentation, perform walkthroughs, and observe validation activities. Appropriate personal protective equipment (PPE) is required.

Frequent motions such as lifting, bending, twisting, squatting, walking, and reaching are required. The role may occasionally require unassisted lifting of up to 50 lbs. Office-based work requires extended periods of sitting and frequent use of hands and wrists while working on a computer.

Work Environment

Work is performed primarily indoors within an office, laboratory, or cleanroom setting. The role involves both independent work and frequent collaboration with other teams. Walking between buildings and controlled environments is required to support on-site activities.

Supervisory Responsibilities

This role does not include formal people management responsibilities; however, the role will provide technical guidance, mentorship, and day-to-day coaching to junior team members and contractors, ensuring adherence to validation best practices and company standards.

Travel

<5% Travel Required

Target Bonus

10%

Work Location:

East Syracuse, NY

New York Pay Range

$76,000 — $113,000 USD

We are an Equal Employment Opportunity (“EEO”) Employer.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!