CSV Engineer Ref:1789
SPGL is a dynamic and well established professional technical services group, operating in a range of market sectors including Bio-Pharmaceuticals, Medical Devices & Diagnostics, Healthcare, Regulated Consumer Products, Chemicals & Mission Critical. We are a responsible, diverse and inclusive organisation, driven by our vision of ‘making quality a way of life’ and a strong desire to achieve more for our customers. We are proud to have a great team of highly skilled, smart professionals who help, care and support both our clients and each other.
- Project experience with rolling out software packages with Pharmaceutical Manufacturing Validation (CSV) experience
- Date Migration activities
- Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities.
- Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s
- Ensures projects (moderate scale & complexity) are managed in conjunction with cGMP regulatory standards.
- Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements.
- Provides technical assistance on current US FDA and EU validation requirements.
- Generates validation documentation (protocols/reports) and aids with the execution of protocols for computerized systems.
- Responsible for the validation documentation through approval and implementation.
- Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
- Investigates/troubleshoots moderately complex validation problems.
- Develops moderately complex protocols to ensure quality standards.
- Bachelor’s or master’s degree in Science (Chemistry), Engineering or IT.
- Strong communication skills
- Capable of working independently and learns fast
- Able to execute project to plan
- Competent knowledge of Computer Systems Validation
- Knowledge of validation publications
- Full understanding of relevant quality and compliance regulations
- Capable of troubleshooting validation issues associated with projects, process Validation Engineer Computerized systems
What SPGL can offer you
We are a people centric company where our staff are the heart and soul of our organisation. If you’re looking for a forward-thinking workplace and see yourself as a dynamic professional, come and join our team and you can expect:
- Competitive starting salary
- Excellent private healthcare
- Pension and life insurance
- A variety of challenging projects, with blue-chip customers
- International project assignments
- Continuous training and personal development
- Strong career pathway
- A mix of young and experienced professionals
- Multi-cultural and caring organisation
- An equal opportunity employer
- Regular team building events and social gatherings
For further information on this role please e-mail email@example.comApply