Validation Engineer I

Purpose and Scope

The Validation Engineer I is responsible for supporting the planning, execution, and documentation of validation activities in a sterile injectable manufacturing environment. Responsibilities include equipment, facilities, utilities, cleaning and process validation in compliance with cGMP, FDA, EU, and other regulatory requirements.

Essential Duties & Responsibilities

• Assist in the development and execution of validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities (e.g., CTUs, WFI, HVAC), and processes.
• Support cleaning and sterilization validation activities, including autoclaves, SIP systems, and aseptic processes.
• Participate in risk assessments (e.g., FMEA) and support change control evaluations.
• Collect and analyze validation data, prepare summary reports, and ensure documentation is accurate and audit-ready.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Quality Control.
• Maintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.
• Support investigations and CAPAs related to validation deviations or failures.
• Stay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.
• Participate in required annual hazardous waste training, including container and tank management and inspections, generation of hazardous waste, transfer of hazardous waste, and spill response per Chemical Spill Procedures.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• 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.
• Some experience in validation, preferably in a sterile pharmaceutical or biotech environment.
• Understanding of GMP, FDA and EU regulatory requirements a plus.
• Experience qualifying CTUs and using Ellab temperature mapping systems a plus.

Working Conditions

• Working conditions include general office environment, laboratory and manufacturing settings (clean rooms where gowning is required).
• Business demands may require working extended hours.