Validation Engineer II

Responsibilities

• 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 cleaning and sterilization 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.
• Provide validation guidance and support to teams in developing and executing protocols.
• Support 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.
• Participate in required annual hazardous waste training.
• Respond to spills per the Chemical Spill Procedures.
• Perform other related duties as assigned.

Qualifications

• Proficient in Microsoft Office Suite.
• Knowledge of GMP regulations and validation guidelines.
• Strong technical writing and documentation skills.
• Excellent oral and written communication skills.
• Effective organizational and project management skills.
• Effective troubleshooting and problem-solving skills.
• Ability to maintain gowning requirements for controlled areas.
• Ability to manage multiple projects simultaneously.
• Ability to work both independently and as part of a team.
• Ability to develop and implement creative solutions to problems.

Education & Experience

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• Minimum of 2 years’ experience in validation, preferably in a sterile pharmaceutical or biotech environment.
• Strong understanding of cGMP, FDA, and EU regulatory requirements.
• Familiarity with aseptic processing, cleanroom classifications, and environmental monitoring preferred.
• Experience with validation software or electronic document management systems preferred.