Job Title: Commissioning, Qualification, and Validation (CQV) Engineer

Job Overview: We are seeking a highly skilled and motivated Commissioning, Qualification, and Validation (CQV) Engineer to join our team. This role involves overseeing the validation and qualification of equipment, systems, and facilities within a regulated environment. The CQV Engineer will ensure compliance with industry standards and current Good Manufacturing Practices (cGMP) by executing validation protocols and preparing detailed documentation throughout the validation lifecycle.

Key Responsibilities:

• Lead and execute commissioning, qualification, and validation activities for equipment, systems, and facilities.
• Develop, review, and approve validation protocols (IQ/OQ/PQ) and associated documentation.
• Coordinate and conduct installation, operational, and performance qualification activities for new and existing systems.
• Create and maintain detailed validation documentation, including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols (IQ, OQ, PQ).
• Execute and document validation activities (IQ/OQ/PQ) for equipment, systems, and utilities, ensuring compliance with all regulatory standards.
• Write, review, and approve technical reports, summarizing completed validation work and outcomes.
• Collaborate with cross-functional teams to support qualification and validation efforts for ongoing projects.
• Support and contribute to risk assessments and GAP analysis during qualification and requalification processes.
• Implement industry best practices and lessons learned to optimize validation processes.
• Ensure adherence to regulatory requirements, internal policies, and quality standards.
• Support the Engineering team in developing and maintaining validation, requalification, and maintenance programs.
• Assist with continuous improvement efforts for validation processes and documentation systems.
• Perform assigned Quality Systems tasks such as Change Control, CAPA, Non-Conformities, and Document Management.

Education & Experience Requirements:

• Education: Bachelor’s Degree in Engineering, Life Sciences, or a related technical field.
• Experience: 5+ years of experience in the pharmaceutical or biotechnology industry, with hands-on experience in commissioning, qualification, and validation.
• Experience with cGMP regulations and industry standards.

Skills & Qualifications:

• Strong technical writing skills, with the ability to create clear, detailed, and accurate documentation.
• Excellent organizational skills with the ability to manage multiple validation projects simultaneously.
• Strong analytical and problem-solving skills, with attention to detail.
• Ability to work independently and as part of a collaborative, cross-functional team.
• Excellent verbal and written communication skills, with the ability to communicate complex technical concepts clearly to diverse audiences.
• Familiarity with validation tools, systems, and equipment in the pharmaceutical or life sciences industry.

Language Requirements: Proficiency in English (written and spoken).