Validation Engineer

Responsibilities

• Draft and implement Quality System documentation designed to establish good validation practices within the organization.
• Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Support all stages of qualification of Analytical Instrument and Manufacturing equipment.
• Support all stages of qualification of automated manufacturing equipment
• Conduct Analytical Instrumentation Qualifications in accordance with USP and Vertex SOPs.
• Conduct Automation Assessments to ensure compliance with 21 CFR Part 11.
• Coordinate with vendor personnel to schedule and execute of test plans, if required.
• Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required.
• Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality.
• Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc.
• Develop cycles for sterilization processes and validate them, if required.
• Completes assigned training and ensures that they are 100% compliant 100% of the time.
• Ensure that all Validation activities align with the current SOPs, global standards and cGMP guidelines.
• Supports right-the-first time culture for all documents distributed across the organization. Ensure the Validation team reputation and partnership is flourished with the cross-functional teams.

• Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment.
• Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas.
• Receptive to change – Adapts (quickly) to changing circumstances.
• Flexibility for off-shift hours, including weekend and night shift work.
• B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience.
• Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.

• Associate

• Contract

• Information Technology

• Pharmaceutical Manufacturing and Biotechnology Research

Boston, MA

$42,000.00-$50,000.00