Join Our Team as a CQV Specialist (m/w/d)
We are seeking talented individuals to become new members of our team in the pharmaceutical and biotechnology sector, located in Switzerland. If you are passionate about the industry and thrive in a collaborative environment, we want to hear from you!
What We Are Looking For
The Commissioning Qualification Validation (CQV) Engineer will carry out various tasks related to the validation of equipment and facilities. This role involves coordinating the installation of equipment, drafting IQ/OQ/PQ protocols, executing the IQ/OQ/PQ, and documenting results according to cGMP requirements.
Key Accountabilities
- 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, and Risk Assessment.
- Prepare validation documentation deliverables such as URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols (IQ, IOQ, OQ, PQ).
- Execute IQ/OQ and PQ for equipment, systems, and utilities while documenting validation activities.
- Identify efficiencies in the validation program approach and apply lessons learned while staying informed of industry regulatory changes affecting equipment and facility validation.
- Perform assigned Quality Systems activities, including Document Management System, Change Control, Non-Conformities, and CAPA’s.
- Write and/or revise procedures applicable to Engineering activities.
- Support the Engineering group in preparing the validation, requalification, and maintenance program.
Your Background and Experience
- Education Required: Bachelor’s Degree in Science or a Technical field.
- Language: Proficiency in English; German is a valuable asset.
- Work Experience: 3-6 years in the Pharmaceutical Industry.
- Skills:
- Excellent technical writing skills and the ability to document all work thoroughly, accurately, and in a timely manner.
- Strong written and oral communication skills, with the ability to collaborate effectively across departments.
- Outstanding organizational and time management skills.
Apply online using the form below. Please note that only applications matching the job profile will be considered.
We look forward to reviewing your CV and organizing a preliminary phone call to introduce ourselves!
Your Techfirm Team