QA Validation Engineer

Seeking a capable Validation Engineer to work in the RI area. Ideal candidates would have previous experience supporting validation activities within fast-paced pharmaceutical environment. This includes installation, operational and performance qualification of equipment and utilities, environmental qualification, and preparation of all relevant documentation to meet regulatory requirements (includes standard operating procedures, technical reports and risk assessments).

Validation Engineer Key Responsibilities:

The candidate’s responsibilities will include, but are not limited to:

• Develop protocols, provides execution support, data analysis, and report generation for various installation, operational and performance qualification activities.
• Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
• Ensure all aspects of facilities validation adhere to required policies and procedures, including safety and training.
• Investigates / troubleshoots validation problems.
• Support and/or initiate investigations into protocol non-conformances and site deviations.
• Serve as initiator and owner of validation related change controls and corrective and preventative actions.
• Provides input to standard operating procedures related to validation practices.
• Support the implementation of validation programs (e.g., requalification).
• Executing thermal mapping of the facility.

Validation Engineer Qualifications & Experience:

• Bachelor’s degree in Engineering or Science or related field.
• 2+ years of experience within the biotech or pharmaceutical industry
• Must have demonstrated understanding of cGMP.
• Strong problem solving and analytical skills
• Understanding of compliance and regulations.
• Excellent written and verbal communication skills.