Nr ref.: /JOBS.pl
Technical documentation/validation engineer
KEY WORDS: Validation, Validatie, Technical documentation, cGMP, GAMP, ISO13485, ISO9001, QMS, interim, freelance, tijdelijk, contractor, pharma, Medical Devices, Lean six sigma, QA, kwaliteit, kalibratie, calibration, farmaceutica, healthcare, food, installations, cosmetics, sciences, R&D, Chemical, HSE, Master, PhD, Regulatory Projects, Blackbelt, Greenbelt, process validation, CMO, CRO, project, engineer, inginieur, technoloog, FDA, audits
This concerns a temporary assignment for a technical documentation/validation engineer at a major international Medical Devices R&D and Manufacturing organization in Zuid-Holland, the Netherlands.
Duration: 5/6 months
Start date: October/November
Reason for this position is a backlog of technical documentation that needs to be updated. I'm looking for someone with a solid background in technical document reviewing within cGMP and FDA audited environments.
The technical documentation/validation engineer is responsible for:
*Evaluate all current technical documentation and work on the backlog
*Write and update service as well as product related documentation
*Work closely together with the internal validation teams
*Upgrading of software documentation
*Support the R&D and production departments and provide input for new design projects
*Coordinate with the QA officers and managers to promote best practices within the office
*Train and support validation personal
For the role of technical documentation/validation engineer, I'm looking for someone with:
*Deep knowledge on writing technical documentation related to installation, process equipment, cleanrooms and laboratory equipment
*Thorough knowledge on cGMP regulations
*Experience with FDA audits is highly preferably
*Great eye for detail and a strong affinity for Quality Assurance
*A BSc+ degree in relevant area
*Strong communication skills in Dutch and English
*Multiple years practical work experience within the Medical Devices field and related ISO norms (13485)
This client is known to re-hire consultants for multiple projects during the year. Their organization a fast growing on an international scale, so there are a lot of opportunities for future projects.
Interested in this position? Please send your profile to (see below) and I will get in touch with you on a short time notice.
Disclaimer: Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.
Ogłoszenie pochodzi z serwisu Jobs.pl.
Proszę czekać - ładowanie treści...