CQV Engineer

at  PANDA

The Commissioning Qualification Validation engineer carries out a variety of tasks related to the validation of equipment and facilities.

The scope of activities include:

• The coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.
• 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.

Requirements:

• Bachelor’s Degree in Science or Technical field.
• Language: English.
• Work Experience: Level Pharma Industry 3-6 years.

Please refer the Job description for details