Validation Engineer III

Core Hours

Monday - Friday, 8:00 am - 5:00 pm

The Validation Engineer III is responsible for leading validation strategy and execution across multiple systems and processes in a sterile injectable manufacturing environment. Responsibilities include ensuring compliance with cGMP, FDA, EU, and other regulatory requirements and providing technical leadership and mentorship to junior engineers.

• Plan and coordinate validation activities for cross‑functional projects, including but not limited to validation plans, protocols, and reports
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes.
• Lead and assist with commissioning activities, including the development of requirements and specifications, risk assessments, acceptance and verification testing, and cycle development.
• Lead cleaning validation and sterility validation activities, including autoclaves and SIP systems.
• Conduct risk assessments (e.g., FMEA) and support change control evaluations.
• Analyze validation data, prepare comprehensive reports, and ensure audit readiness.
• Collaborate with cross‑functional teams including QA, Manufacturing, Engineering, and Quality Control.
• Maintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.
• Evaluate and implement new validation technologies and methodologies.
• Provide validation guidance and support to teams in developing and executing protocols.
• Lead investigations and CAPAs related to validation deviations or failures.
• Contribute to continuous improvement initiatives in validation practices.
• Stay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.
• Support internal and external audits and inspections.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform other related duties as assigned.

• Center on People: We commit to support the well‑being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands‑on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

• Proficient in Microsoft Office Suite.
• Knowledge of GMP regulations and validation guidelines.
• Proven ability to lead medium to large validation projects.
• Advanced technical writing and documentation skills.
• Excellent oral and written communication skills.
• Strong project management and cross‑functional leadership skills.
• Effective troubleshooting and problem‑solving skills.
• Knowledge of scientific and risk‑based approaches aligned with industry best practices.
• Ability to maintain gowning requirements for controlled areas.
• Ability to lead complex validation initiatives and mentor junior staff.
• Ability to…