CQV Engineer (m/f/d)

CQV Engineer (M/F/D)

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.

Tasks :

• 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

Qualification:

• Bachelor’s Degree in Science or Technical field

• German mandatory (English a real plus)

• Advanced Level Pharma Industry minimum 5 years 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

Requirements: