Equipment Validation Engineer

Portsmouth, New Hampshire, United States

It's an onsite

Job Summary:The Equipment Validation Specialist (Levels III & IV) ensures all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. The role provides Operations, Quality Assurance, and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required, ensuring a quality, compliant manufacturing environment.

Key Responsibilities:

• Ensure validation of all critical GMP equipment and systems in accordance with user requirements and process parameters.
• Maintain compliance with global regulatory guidelines and industry best practices.
• Develop and execute validation protocols and reports for equipment and systems.
• Provide scientifically sound, documented evidence to support validation activities.
• Collaborate with Operations, Quality Assurance, and regulatory bodies to ensure validation requirements are met.
• Conduct risk assessments and identify potential validation issues.
• Troubleshoot and resolve validation-related problems in a timely manner.
• Maintain accurate and comprehensive documentation of validation activities.
• Provide training and support to junior team members and other departments as needed.

Qualifications:

• Bachelor's degree in Engineering, Chemistry, or a related field.
• Minimum of 7 years of experience in equipment validation or a related field.
• Strong understanding of GMP regulations and validation principles.
• Excellent analytical and problem-solving skills.
• Strong attention to detail and ability to work independently and as part of a team.
• Effective communication and interpersonal skills.

Preferred Qualifications:

• Master's degree in Engineering, Chemistry, or a related field.
• Experience with validation of equipment in a regulated manufacturing environment.
• Knowledge of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).