Position Details
Sr Computer System Validation Engineer Apply
St Joseph, MO
Contract Duration: 12-36 months
Rate: Negotiable
Responsibilities:
- Excellent employment opportunity for a Sr. Computer system Validation Engineer in the St Joseph, MO area.
- Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports)
- Experience in validating GMP Lab systems and Equipment
- Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.
- Identify and escalate, as necessary project risks and issues to the CSVC Manager.
- Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs.
- Be able to prepare reports on defects and problems that arise during system testing.
- Have solid oral and written communication skills and teamwork skills.
- Be a good team player, able to meet deadlines and handle changing priorities.
- Have strong judgment capabilities to clarify requirements when necessary.
- Have the ability to work with cross functional teams
- Have solid experience working with validated systems.
- Work with business representatives to ensure the test cases reflect business rules and processes.
- Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.
Experience:
- BS in Science or Technical Writing Degree
- GMP/Regulated lab, more than 5 years of CSV experience required.
- Technical writing Experience
- Highly skilled in Computerized System testing and validation in the healthcare industry.
- Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)
- Solid project organizational skills.
- Ability to multi-task.
- Must have strong analytical problem-solving skills.
- Excellent communication including written, verbal, and listening skills.
- Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
- Required Skills: GMP
