CQV Engineer

PharmEng Technology is a global leader in pharmaceutical compliance consulting, providing quality services to manufacturers of pharmaceutical and healthcare products for over 25 years. Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology, and Regulatory Affairs.

We are seeking a full-time experienced CQV Engineer to join our team in France. The successful candidate will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.

• Perform activities related to commissioning, qualification, requalification, and validation independently.
• Commission, qualify, and requalify new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs or FDA.
• Qualify computerized and automation systems.
• Write qualification documents such as VP, IQ, OQ, PQ, and PPQ protocols and reports, risk assessments, and development protocols.
• Support the development of user requirements and functional specifications.
• Participate in all phases of validation projects in accordance with client needs.
• Recommend to management the acceptance and release of qualified equipment, facilities, services, and systems.
• Support the generation and execution of all documentation related to demonstration batches, thermal studies, validation studies for equipment, engineering test runs, and development studies.
• Review technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Batch Production Records, ensuring any document changes meet quality and validation requirements and are in full compliance with regulations, standards, and regulatory compliance issues.
• Provide technical assistance during investigations of process/equipment/cleaning/validation issues and aid in the resolution of validation deviations, protocol discrepancies, and non-conformities.

• Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
• At least 3 years of experience in QA Oversight for C&Q activities, in Biopharma or Pharma industry.
• Generation and overview qualification documents like URS, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.
• Hands-on commissioning, qualification, and validation experience in the following disciplines: facilities (including clean rooms, HVAC), utilities (including WFI/RO/purified water, clean steam, clean air, compressed air and gases, process waste systems), major qualification equipment, process and cleaning validation, equipment qualification, and computer software validation.
• Firm understanding of cGMP validation requirements/guidelines and familiarity with FDA regulatory requirements for the Pharmaceutical/Biopharmaceutical industry.
• Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
• Experience with Microsoft Office Suite.
• Fluency in English and French is a must.
• EU citizenship mandatory.

• Full-Time Position
• Competitive Salary
• Opportunities working for a global company
• Thirty (30) days Holiday
• Continuous Professional Improvement including, but not limited to, courses or seminars

PharmEng Technology is proud to be an equal opportunity workplace. Thank you for your consideration and application We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted. Please, send your CV in English.