CSV Engineer (Serialisation)
Reporting to the relevant Lead, this position will have a significant role in the validation of computerized system. The engineer will participate in the development of custom programs, as well as configurable off the shelf systems. Responsibilities include ongoing evaluation and periodic review of existing validated computer systems; change control. Other responsibilities of this position include generation and execution of validation deliverables and SDLC documents.
- Develops and executes all validation deliverables including execution for:
- Serialisation of Packaging upgrade project
- Automation Projects – OSI PI upgrade / Integrations, Versiondog Upgrade
- MFG/QC Instruments
- Capable of owning issues/deviations and driving them to resolution.
- Leading testing efforts for small to medium sized projects.
- Reviewing vendor protocols, test scripts, and traceability matrix.
- Capable of generating test scripts to meet the user requirements.
- Interacts directly with project teams and the associated vendors.
- Responsible assessing the validation impact of changes made to qualified instruments.
- Other duties as assigned.
Skills & Experience Required:
- Good verbal and written communication skills.
- 5+ years’ experience in Bio-Pharmaceutical or equivalent type life science industry.
- Good organizational skills.
- Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.
- Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
- Must possess a thorough understanding of current industry guidance, including GAMP 5
- Must have direct experience with computer validation and determining computer validation approach.
- Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
- Experience/Knowledge in qualifying DeltaV, OSI PI, Serialisation changes.
- Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Power Point).
- Experience with HP ALM or equivalent software testing/requirements tools.
- Computer Science or Engineering/Science Degree is preferred.