Commissioning Qualification and Validation Engineer DE/EN (M/F/X)
In 12 years, the EFOR Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions.
Our ambition is to build a global leading position of our market in 2028.
Today, we are an innovative organization working with passionate specialists and committed consultants according to our three values: Commitment, Excellence and Sharing
In Switzerland, we work with 300 experts who support our customers on their various projects in the French‑ and German‑speaking parts. We help our customers to diversify and to grow through the work of our consultants and the technical expertise of our Solution & Project Delivery Department.
To strengthen our team in the German part of Switzerland, we are looking for a Commissioning Qualification and Validation (CQV) Engineer DE/EN (M/F/X) to start as soon as possible.
Description
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
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.
Requirements
* Fluent German and English (C1)
* Bachelor’s Degree in Science or Technical field.
* Advanced Level Pharma Industry 5-10 years. With extensive GMP 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.
This is a 100% on-site role.
EFOR Group’s legal entity, KALIPSIA AG is based at Holbeinstr. 50, 4051 Basel, is recruiting and managing client relationships. The recruitment is for assignments and projects carried out for our clients, as well as for company mandates.
Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.
Do you want to join a dynamic and ambitious company? EFOR is made for you.
Send your application to: brendan.walsh@efor-group.com
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