Senior Validation Engineer

Location:

Wavre – Walloon Brabant, Wallonia, Belgium

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Health, Nursing & Social Services Jobs

Advertiser:

NonStop Consulting

Job ID:

125813932

Posted On: 

13 February 2023

Senior Validation Engineer – Contribute to multi-site Automation CAPEX Program

An excellent opportunity has arisen for an experienced professional to join as a Senior Validation Engineer.

In this role, you will be responsible for ensuring compliance with critical requirements such as Cyber Security, Automation Obsolescence Management, Data Integrity, and more. As a member of the highly skilled team, you will work on projects at both the Belgium and Global Operations level, making a significant contribution to the success of the multi-site Automation CAPEX Program.

This is an exceptional opportunity for an individual looking to take their career to the next level and make a real impact in the field of CAPEX Automation. With the ability to work at the forefront of innovation and drive success on a grand scale, this role offers a unique and challenging experience for the right candidate.

We encourage individuals with relevant experience and a strong commitment to excellence for this exciting opportunity. Join us today and be a part of a team that is shaping the future of CAPEX Automation.

Responsibilities:

Report directly to the Director of Automation of Capital Investment and work closely with the Vx Capital Investment team.

* Write, review, and approve validation plans and reports
* Help define validation requirements with Editor, Integrator, and Engineering Office
* Review and approve Technical Change Description and protocols
* Check SOPs and Templates specific to CVS
* Make sure qualification and validation activities follow GSK methodologies
* Improve validation system to meet current GMP requirements
* Contribute to improving Global Standards and Technical Standards
* Communicate with site automation and QA CSV to capture needs
* Align with Global QA CSV to ensure consistency

Requirements:

* Fluency in French & English
* Masters degree in Sciences / Biological Engineering (e.g. Pharmacist /Master in Sciences / Bio Engineer)
* 10 years + experience in computerized system validation, operations and project management;
* CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11)
* Validation practices and guidelines (life cycle approach, ICH, ASTM E2500)
* Good knowledge of automation and systems like: Archestra, OsiPi, Dmg, AvevaReport, PEMS
* GSK experience in CSV/Quality/Automation is advantageous

Benefits:

* Attractive salary and benefit package
* State of the art training provided
* Flexibility in working hours and home based work
* Career development opportunities (learn from the experts and become the expert).

If this job appeals to you please apply here or send your CV to me, Kauthar Alkaytab, on the NonStop Consulting website or on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg and the Czech Republic and we hold labour leasing licences for all EU8 countries. our website for a full list of the niche markets we cover.

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