CQV Engineer (m/w/d)

Key Responsibilities:

• Lead and execute validation activities for facilities, utilities, and equipment, ensuring alignment with regulatory requirements and industry standards.
• Draft, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Prepare and review validation documentation deliverables such as User Requirement Specifications (URS), Design Qualification (DQ), Failure Mode and Effects Analysis (FMEA), Risk Assessments, Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT).
• Perform gap analysis and risk assessments to identify validation needs and potential improvements.
• Collaborate with engineering teams to develop and maintain validation and requalification programs.
• Write reports summarizing completed validation activities, ensuring accuracy and adherence to timelines.
• Stay updated on industry trends and regulatory changes, applying lessons learned to enhance the validation program.
• Assist with Quality Systems activities, including Document Management, Change Control, Non-Conformities, and Corrective and Preventive Actions (CAPAs).
• Draft and revise procedures related to validation and engineering activities.
• Support the preparation and execution of maintenance programs for validated systems and equipment.
• Perform other related duties as assigned.

Qualifications:

• Education: Bachelor’s Degree in Science or a Technical field.
• Experience: 5-10 years of advanced experience in the pharmaceutical industry, with a focus on equipment and facility validation.
• Skills:
  • Strong technical writing skills with the ability to produce thorough and accurate validation documentation.
  • Excellent written and verbal communication skills, with the ability to work effectively across departments.
  • Strong organizational and time management skills, with the ability to manage multiple priorities.
  • Familiarity with cGMP requirements and validation life cycle.

Languages:

• Proficiency in English (written and spoken).

This role offers an opportunity to contribute to ensuring the safety and compliance of critical equipment and systems within a dynamic and regulated environment.