CQV Engineer - 6 months (m/w/d)

Role Description: 

The CQV Engineer ensures equipment, systems, and facilities meet regulatory and operational standards. Responsibilities include:

• Drafting and executing IQ/OQ/PQ protocols.

• Managing validation life cycle activities for facilities, utilities, and equipment.

• Preparing and reviewing validation documents (URS, DQ, FMEA, Risk Assessments, FAT, SAT, IQ, OQ, PQ).

• Conducting and documenting validation activities in compliance with cGMP.

• Supporting quality systems activities such as document management, change control, and CAPA.

• Developing and revising engineering-related procedures.

• Identifying efficiencies in validation approaches and staying updated on regulatory changes.

Profile:

• Education: Bachelor’s Degree in Science or a Technical Field.

• Experience: 5-10 years in the pharmaceutical industry.

• Skills:

  • Strong technical writing and documentation abilities.

  • Effective communication and collaboration skills.

  • Excellent organizational and time management capabilities.

  • Knowledge of cGMP and industry best practices.

  • Attention to detail and accuracy in validation processes