CSV Engineer
Date Posted: April 26, 2024
Job Description
We are currently seeking a meticulous Validation Engineer to join our pharmaceutical team in France. The ideal candidate will be responsible for commissioning, qualifying, and requalifying manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs or FDA standards.
Key Responsibilities
- Conduct commissioning, qualification, and requalification of new or existing manufacturing and laboratory equipment, facilities, services, and systems in accordance with regulatory requirements.
- Write qualification documents such as VP, IQ, OQ, PQ, and PPQ protocols and reports, as well as risk assessments and development protocols.
- Provide support for the development of user requirements and functional specifications.
- Actively participate in all phases of validation projects, evaluating projects and providing technical information to others.
- Recommend to management as to the acceptance and release of qualified equipment/facilities, services, and/or 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 to ensure compliance with regulations and standards.
- Provide technical assistance during investigations of process/equipment/cleaning/validation issues and aid in the resolution of validation deviations, protocol discrepancies, and non-conformities.
- Provide effective solutions for the management of system deviations and non-conformities through the CAPA System.
Required Qualifications and Skills
- Bachelor’s degree in a technical field (engineering, biology, chemistry, pharmacy).
- Minimum of 3 years of experience in QA Oversight for commissioning and qualification activities, preferably in the biopharma industry.
- Hands-on experience with commissioning, qualification, and validation in facilities, utilities, major 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.
- Proficiency in Microsoft Office Suite.
- Fluency in English is required.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E
