Validation Engineer

Position Summary

This position requires knowledge of cGMPs, excellent technical writing, and problem-solving skills.

Responsibilities

• Development and execution of installation, operational, and performance qualification protocols/test cases and reports
• Ensuring qualification and validation activities meet internal and external compliance requirements
• Effectively manage projects to deliver on time and consistent results
• Coinciding validation activities with the appropriate functional groups
• Operating and maintaining data acquisition systems and validation testing instruments used for temperature mapping including Kaye Validator and wireless data loggers
• Maintaining the validated state of assets through periodic monitoring
• Evaluating changes to the validated state of systems through change control procedures and participating in the planning and implementation of changes
• Representing department as subject matter expert (SME) presenting validation activities during regulatory inspections
• Understanding of key Data Integrity principles (ALCOA+) to ensure requirements are aligned to appropriate testing strategies
• Participating in Process Flow Teams as needed

Qualifications

• Minimum of 0 years to 5 years experience in qualification/validation of typical GMP utilities, facilities, computer systems and/or process equipment in a pharmaceutical/ biopharmaceutical facility
• Bachelor’s degree in Engineering, Computer Science, Science, or related discipline
• Knowledge of validation lifecycle approach and FDA/international regulatory requirements
• Ability to work with others in a fast-paced environment
• Strong communication skills, both oral and written, to effectively communicate technical information in a clear and concise manner within a GMP environment
• Strong analytical, problem solving, and excellent interpersonal skills
• Proficient in MS Office (Word, Excel, Project, Outlook, etc.)
• Experience with the following applications/systems is a plus: TrackWise, Maximo, LIMS

Pay

The anticipated compensation for this role is $72,000 - $116,000

Schedule

Hybrid work flexibility may be available based on business needs