CQV Specialist

Key Accountabilities:

• The CQV Engineer will be involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others. The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
• Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
• Write reports of completed validation activities. Work to identify efficiencies in the validation program approach. Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
• Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s. Writing and/or revising procedures applicable to the Engineering activities. Support the Engineering group to prepare the validation, requalification, and maintenance program. Perform other duties as assigned.

Requirements:

• Education Required: Bachelor’s Degree in Science or Technical field. 
• Mn 3 years of relevant experience.
• Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
• Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
• Excellent organizational and time management skills.