Commissioning Qualification Validation Engineer
Vor 3 Tagen
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
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