Job Description: Validation Engineer I/II

Purpose

The Validation Engineer is responsible for supporting the Validation team in achieving project milestones. Responsibilities include executing installation, operational, and performance qualifications for equipment and utilities, conducting environmental and process validation, and preparing documentation to meet regulatory requirements for new and existing products. This documentation includes standard operating procedures, technical reports, and risk assessments. Advanced knowledge of validation processes is required.

Supervisory Responsibility

This role may supervise other positions.

Essential Job Functions and Duties

• Develop moderately complex validation protocols, provide execution support, analyze data, and generate reports for installation, operational, and performance qualification activities.
• Ensure all validation activities comply with internal procedures, cGMP, industry standards, and regulatory guidance.
• Investigate and troubleshoot validation issues.
• Support or lead investigations into protocol non-conformances and site deviations.
• Act as initiator and owner of validation-related change controls and corrective and preventive actions.
• Contribute to standard operating procedures related to validation practices.
• Support validation program implementation (e.g., requalification activities).
• Represent the Validation department in team meetings and projects.
• Provide technical assistance to less experienced Validation Engineers as needed.

Special Job Requirements

• Strong written and verbal communication skills.
• Proficiency with Microsoft Office, Excel, and Visio.
• Ability to collaborate effectively within a diverse, matrix-style organization.
• Strong multitasking and organizational abilities.
• Attend meetings and offer subject matter expertise for deliverables as required.

Education / Certifications / Licenses

• Preferred: Bachelor’s degree in Engineering.

On-the-Job Experience

• Bachelor’s degree in Engineering with 0–8 years of Validation experience, or a Master’s degree with 0–5 years of Validation experience.

Required Skills / Abilities

• Communicate effectively with employees across all levels.
• Report project activity clearly and concisely.
• Collaborate effectively with project team members.
• Negotiate and compromise to achieve project goals.
• Listen and respect team members' opinions while resolving conflicts constructively.

Physical Demands

• Work Environment: Regularly seated for extended periods.
• Movement: Frequent standing, sitting, handling objects, and reaching. Occasional walking, climbing, balancing, stooping, kneeling, crouching, or crawling.
• Lifting: Frequently lift/move up to 10 lbs; rarely lift/move up to 25 lbs.
• Vision: Frequent close vision and focus adjustment.
• Communication: Frequent talking, hearing, and using communication tools (phone/email).