Join an exciting environment where your expertise can play a crucial role in ensuring compliance and quality in the pharmaceutical sector. We are looking for a dedicated professional to drive the validation processes for critical computerized systems, ensuring they meet stringent regulatory standards.
The ideal candidate is a skilled
Validation Engineer
with a solid background in project management and validation of software packages. If you are detail-oriented, technically adept, and thrive in a compliance-focused environment, this position may be a great fit for you.
* You develop, implement, and execute
URS
,
SIA
,
DQ
,
IQ
,
OQ
,
PQ
,
RV
, and
TM
activities.
* You generate validation documentation including protocols and reports, ensuring compliance with cGMP and regulatory requirements.
* You manage validation documentation through approval and implementation processes.
* You perform validation of systems in alignment with industry standards and cGMP procedures.
* You ensure that the validated status of computerized systems remains compliant at all times.
* You manage projects according to all necessary regulatory standards.
* You keep informed about emerging validation regulations and provide technical guidance on US FDA and EU requirements.
What are we looking for?
* You have at least
3 years of experience
in a similar role within the pharmaceutical sector and GMP environment.
* You possess competent knowledge of
Computer Systems Validation
.
* You have a full understanding of relevant quality and compliance regulations.
* You are capable of troubleshooting validation issues effectively.
* You are an excellent communicator.
* You are able to work independently and demonstrate quick learning abilities.
* You can execute projects according to established plans.
* You have good knowledge of
English
and
Dutch
.
* Experience with DCS systems, specifically
Emerson DeltaV
, is an advantage.