Senior Labware LIMS CSV engineer with GMP
Responsibilities
- Develop Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)
- Develop Validation testing strategy in accordance with company's policy and procedures
- Working closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projects
- Assist with understanding the business requirements, analyze and suggest technical solution for LIMS projects
- Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS application
- Create, review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projects
- Qualification protocols execution and final report view and approval for LIMS projects
- Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects
- Learn and become proficient with the EDMS (Electronic Data Management System), for
- document review and approval and ELMS (Electronic Learning Management System) for documenting and performing assigned training.
- Prepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- Forms
- User Manuals / User Guides / User References / Quick Reference Guides and Training Material
- Training Plans
- Reference Documents
- Specifications
- Reports
- Work independently but recognize the need to consult stakeholders and keep them informed of progress.
Required Experience / Skills:
- Minimum of 3-5 years of experience working on a Labware LIMS application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.
- Advanced knowledge and expertise Computer System Validation, FDA & international requirements and Part 11 requirements.
- Ability to master technical content through interaction with subject matter experts.
- Effective communication and interpersonal skills.
- Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.
- Understanding of programming and relational database concepts is required.
Required Education:
- BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.
