The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that have been newly installed, upgraded, replaced and/or modified in the cGMP Manufacturing Facility as well as its related manufacturing support areas, which may include Facilities/ Engineering, Quality Assurance, Supply Chain, and Quality Control.
- Review and help author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes
- Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements.
- Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.
- Evaluate and analyse qualification data collected during projects, while verifying the acceptability of the data and compliance with the approved protocol.
- Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed by the Validation Committee
- Provide input and assist in the development of validation policies and procedures.
- Effectively interact and provide validation guidance to other departments.
- Assist the department manager in developing realistic time and resource requirements for validation activities in support of the company's expectations.
- Provide input and assist in change control assessment and Part 11 assessment for validated systems.
- Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflect validated conditions.
- Assist department manager on other types of projects/managerial responsibilities as needed
Minimum Qualifications:
- BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology-related field.
- Minimum of 8 years' work experience in a biopharmaceutical/pharmaceutical manufacturing environment, of which 4 years are directly involved in validations.
Company Description
NexPro Technologies offers robust, responsive and value-driven IT consulting and placement services.