Position Title: Commissioning, Qualification & Validation (CQV) Engineer
Location: Visp, Valais
Languages Required: Fluent in German and English
Industry: Pharmaceutical / Biotechnology
Experience Level: 5-10 years in the pharmaceutical industry
Contract Duration: 6 Months with the possibility to extend
Role Summary:
As a CQV Engineer, you will play a key role in ensuring the compliance and readiness of equipment, systems, and facilities through comprehensive validation activities. You will be responsible for planning, coordinating, executing, and documenting qualification processes in line with cGMP standards and industry best practices.
Key Responsibilities:
* Coordinate and support the installation and commissioning of equipment and systems.
* Prepare, review, and execute qualification protocols (IQ/OQ/PQ).
* Author and maintain validation documentation including URS, DQ, FMEA, risk assessments, FAT, SAT, and final reports.
* Evaluate and optimize validation lifecycle activities with a focus on continuous improvement and compliance.
* Perform gap analyses and risk assessments in relation to validation scope and strategy.
* Document validation outcomes thoroughly and ensure traceability and compliance with regulatory requirements.
* Support quality system elements including Change Control, CAPA, Non-Conformances, and Document Management.
* Contribute to the development and maintenance of engineering procedures, validation plans, and requalification programs.
* Stay current with industry trends, guidelines, and regulatory changes, integrating updates into validation approaches.
* Collaborate effectively across departments, including Engineering, Quality, and Manufacturing.
* Perform other engineering and validation-related duties as assigned.
Qualifications:
* Bachelor's degree in a scientific or technical field (e.g., Engineering, Biotechnology, or related discipline).
* 5-10 years of hands-on experience in CQV within the pharmaceutical or biotechnology industry.
* Strong understanding of GMP, GAMP, and regulatory guidelines relevant to equipment and facility validation.
* Proven experience in drafting and executing IQ/OQ/PQ and preparing associated documentation.
Key Skills:
* Excellent technical writing and documentation skills.
* Strong interpersonal and cross-functional collaboration abilities.
* High attention to detail with solid organizational and time management skills.
* Ability to handle multiple tasks and projects in a dynamic, deadline-driven environment.
If you are interested in this opportunity, we look forward to receiving your CV or if you have any questions, contact Nemanja Pavlovic.
Check out all open positions at Experis at www.experis.ch
Due to Swiss work permit restrictions, we can only consider applications from EU citizens or holders of valid working permit in Switzerland.
#J-18808-Ljbffr