CSV Engineer

Quanta part of QCS Staffing; Paris; Sur place; EUR 80 000 - 100 000; Plein temps

Résumé du poste

An innovative global (bio)pharmaceutical manufacturing organization is seeking a CSV Engineer to lead their expansion project in a picturesque Paris location. This role involves being the Subject Matter Expert for Computerised Systems Validation, developing risk-based testing strategies, and ensuring compliance with GAMP standards. You will collaborate cross-functionally to maintain the highest quality standards while managing risks to product quality and patient safety. Join a forward-thinking team dedicated to enhancing the manufacture of Biologics and making a significant impact in the industry. If you are passionate about quality assurance and validation, this is the perfect opportunity for you.

Qualifications

• Expertise in Computerised Systems Validation and risk management.
• Experience in developing risk-based testing strategies.

Responsabilités

• Manage site strategy for Computerised Systems Validation.
• Ensure compliance with regulatory requirements and quality standards.

Connaissances

Computerised Systems Validation

Risk Management

GAMP Compliance

Cross-functional Collaboration

Quality Risk Management

Formation

Bachelor's degree in Engineering or related field

Outils

Validation Management Plans (VMP)

Validation Protocols (VP)

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Description du poste

CSV Engineer / Lead - Paris - 12-Month Contract

Our client, a global (bio)pharmaceutical manufacturing organisation, is recruiting for a CSV Engineer to join them on their new expansion project. Based in a charming French location, this is on a contractual basis and will involve significantly growing the site's capacity for the manufacture of Biologics.

Responsibilities and Requirements:

• Site Subject Matter Expert for Computerised Systems Validation.
• Responsible for developing and managing the site strategy towards CSV.
• Develop and manage risk-based testing strategies for computerised systems to ensure that potential risks to product quality are appropriately managed.
• Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
• Support vendors to ensure adherence to and application of GAMP.
• Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
• Work cross-functionally to ensure site alignment with lifecycle requirements.
• Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
• Support development of CSV competencies within both Validation and across the business.
• Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
• Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment always meets regulatory requirements with a target of zero impact to routine operations.
• Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
• Support the implementation of validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
• Highlight risks to product quality, patient safety, and/or data integrity throughout the validation lifecycle so that they are understood, transparent, and can be managed through the application of a quality risk management approach.
• Application of risk and science-based tools to drive execution strategies and support issue resolution.

If this role is of interest to you, please apply now!