Validation Engineer

le contenu du travail

???? EFOR-CVO IS HIRING IN BELGIUM ????

Who are we ?

EFOR-CVO is the Life Sciences offer of the EFOR Group. Result of the merger of 3 major consulting players: EFOR Healthcare, leader in the world of Medical Devices, CVO-EUROPE, a real player in the pharmaceutical industries and Soladis, an expert in digital and data processing.

The pooling of our expertises has enabled us to consolidate our position as the European leader in life sciences consulting and to build a complete and unprecedented offer by intervening on the entire product life cycle.

Supported by our Technical Expertise Center, our consultants contribute to boost the projects of more than 350 Major Companies, SMEs, Pharmaceutical and Medical Device Startups!

Our need

One of our client active in the pharmaceutical industry and located in the Hainault province in Belgium is looking for a Quality Validation Engineer.

Your responsibilities

To review all the Validation documents related to different CAPEX projects :
- Equipment modification project
- Purification/Process/Cleaning projects
- Packaging projects if needed

The Quality Validation Engineer gives the quality oversight in the different validation strategies that are discussed, and then review and approve all the validation documents in a quality perspective.
Act as quality validation representative on multiple working teams and is empowered to make strategic Quality Validation decisions.

% of time

85% : Review/approval of validation documentation from projects (RA, DQ, IQ, OQ, PQ, PPQ) and associated specification documents (URS, Functional/ Design Specification).
10% : Provide quality guidance for the development strategy and risk analysis related to the validation.
5% : Provide support in quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system with the support, if needed, of a Quality Validation Engineer II, Senior QV or the Lead.

Your Key Skills, Abilities, and Competencies

• Main expertise in Process Validation, Cleaning Validation, Equipment Validation, with understanding of the automation part of the equipment.
• Nice-to-have: expertise/experience in CSV, Data Integrity
• Exposure and/or knowledge of Validation and Engineering functions.
• Experience about Quality pillars (QA, QC, Systems and Compliance) including cGMP regulations.
• Management and leadership skills
• Strong oral and written communication skills with teams, peers, global partners
• Teamwork skills. Develop and maintain good working relationships with customer groups and support an positive environment of teamwork and collaboration
• Critical thinking and demonstrated problem solving skills.
• Good Organizational skills, Set clear priorities
• Assertivity skills
• Autonomous
• Flexibility
• Self-motivated and driven to independently accomplish department goals and objectives

Your profile

• Master Degree in Pharmacy or equivalent with experience
• >5 years in Quality Validation, or >5 years in Validation with some other experience in Quality (Quality mindset)
• Languages: English, French

Interested to take part in this great challenge ?

Thanks to send your resume to the following email address : francois.gillard@cvo-europe.com
Looking forward to meeting you soon !