Validation Engineer to develop, review, and manage the execution of validation activities for the facility utilities, equipment and processes used in the manufacture and testing of cGMP products. Validation Engineers are recognized as a strong quality presence and technical resource.
Responsibilities:
and re validation of critical systems and utilities. Establish a Master Validation Plan, review and implement all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), re qualification
Review, plan, schedule and implement new and existing validation projects including product batching systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases.
Develop and prepare protocols for process and cleaning validation, equipment commissioning
Coordinate and oversee scheduled validation and qualification activities with new and existing production runs. Teaming with operators, process and analytical development personnel, quality control staff, customers and external contractors and service providers.
Review and analyze analytical and physical data generated from executed validation/qualification activities. Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals.
Work with Development, Manufacturing and Quality personnel to generate risk management deliverable for new projects (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis).
Be a member of the Change Management System to determine the impact of proposed changes to the validation/qualification status of equipment, processes, software, and/or facilities.
Develop and provide training and mentoring on validation concepts.
Report status and progress of validation/qualification activities or projects to the Leadership team.
Skills and Qualifications:
·Bachelor’s degree in science or engineering. Chemical Engineering degree preferred.
·3+ years of thorough experience in pilot lab, bulk lab, or related validation process development.
Experience working in a fast-paced consumer goods/regulated company strongly desired; experience in the cosmetics/personal care and contract manufacturing industry preferred.
Knowledge of cGMP and GLP
Demonstrate initiative and provide complete follow-through on areas of responsibility.
Easily adaptable to changing circumstances.
Strong interpersonal skills with a demonstrated ability to work across functions and cultures and interact with all levels of the organization required.
Demonstrated ability to handle multiple projects at once, work under pressure, apply judgment and ask for aid in prioritizing as applicable.
