Validation Engineer

Perform GMP computerized system validation projects in compliance with GMP, 21 CFR Part 11, Annex 11 and Data Integrity.

Ensure that GMP systems meet intended uses and comply with applicable regulations, current industry practices, and *** policies and procedures. Validation projects may include manufacturing systems, lab systems, and steady state activities around these applications.

Plan and establish technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.

Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.

Participate as the validation representative in project team activities and process design to ensure cGMP compliance and interdepartmental consistency within the validation program.

Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.

Coordinate and provide training and/or opportunities for career development of others.

Perform other duties as assigned.

Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.