Overview:
I am looking for experienced Validation Consultants/ Project Managers seeking a hands-on role that allows them to impart their knowledge and expertise on validation projects of digitial technologies. Projects will involve working closely with clients to assist with all aspects of the validation process, including scope determination, preparing the URS and Validation Master Plan, compliance assessments, preparing documentation, developing & executing test scripts, and taking ownership for these projects.
If you enjoy a challenge, want to leverage your experience to make decisions, see your ideas actioned and thrive in an environment that changes rapidly – this is a great role for you! In return you will be able to broaden knowledge in the informatics and digitalisation market and in technologies such as ELN, LIMS, Lab execution, manufacturing systems, knowledge management, semantic technologies, data lakes and more.
Responsibilities:
- To carry out validation activities, both as project manager and as an active participant of project teams performing required duties.
- Meeting with customer domain experts to understand and document their business challenges, and requirements
- Continually assess the project delivery to ensure it is successful
- Maintain awareness of current trends in compliance and computer software validation
- Scientific Degree qualification subject such as biology, biotechnology, chemical engineering or chemistry
- Domain experience in LIMS, ELN, SDMS, LES or lab digital transformation projects
- Experience in IQ, OQ, PQ, CSV
- Strong project planning, deadline management and interpersonal skills
- Experience of working to FDA GMP or other regulatory guidance
- A structured approach to work
The primary office location will be from home, but the individual will be expected to work from time to time at other locations both in the UK and overseas.