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

The scope of activities includes 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.

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.

Education Required:

• Bachelor’s Degree in Science or Technical field. Language: English. Work Experience: Advanced Level Pharma Industry 5-10 years.

Skills:

• 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.
• Fluency in English and German is mandatory