Commissioning Qualification Validation Engineer

Commissioning Qualification Validation Engineer

About the Company: Located in Visp, a leading life sciences company is seeking a skilled Process Engineer. The organization is renowned for its innovative biopharmaceutical and specialty ingredient solutions, with a strong commitment to quality and sustainability.

About the Role: 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 to cGMP requirements.

Responsibilities:

• 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).
• 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:

• Bachelor’s Degree in Science or Technical field.
• 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.

Seniority Level: Mid-Senior level

Employment Type: Contract

Job Function: Pharmaceutical Manufacturing