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Computer Systems Validation Specialist

Location:Tampa, FL
Salary Range:Competitive Package
Exempt/Non-Exempt:Exempt
Benefits:Excellent Benefits
Employment Type:Full Time
Department:QA
Description:Pilgrim Software, Inc. is a world-leading provider of Enterprise Risk, Compliance and Quality Management software solutions for highly regulated industries. Pilgrim has pioneered effective, integrated software solutions for the Life Science industries, as well as manufacturers in the automotive, aerospace and defense, and other non-FDA regulated industries. Pilgrim’s reputation for excellence in innovation has attracted an impressive portfolio of global customers. More than a half-million end-users employ Pilgrim products every day to meet the diverse challenges of the world’s highly competitive marketplace. Pilgrim’s fully Web-based, integrated solutions help businesses centrally manage domestic and international operations to ensure product safety and compliance, reduce manufacturing costs and improve customer satisfaction.

The Computer Systems Validation Specialist is responsible for planning, scheduling, execution and leading validation project assignments. Validation assignments include design, development, validation, qualification, and implementation of new and existing products. This individual shall lead cross-functional project teams in the development and implementation of the validation plan and protocols. Other responsibilities include the review and approval of change controls supporting an integrated life-cycle approach to the Pilgrim computer systems implementation and validation.
Duties:Principal Duties

Each job duty is followed by the approximate percentage of time dedicated to each element.
a) Validation Execution 50%
Manage, lead, prepare, review and execute validation protocols (IQ/QQ/PQ)
b) System Disposition 20%
Analyze protocol test results, presentation of conclusions and recommendations to clients, ensuring that projects are implemented in accordance with the agreed scope and time lines
c) Project Management 20%
Organize, schedule and track validation projects in order to meet client requirements and agreed time lines
d) Other Duties as Assigned 10%
Other tasks related to the department, such as special projects or research, will be completed as assigned.

Decision Making
N/A

Supervisory Responsibility
N/A

Dollar Responsibility
N/A
Qualifications:EDUCATION AND SKILLS

Minimum Educational Requirement
Technical degree in related discipline (Computer Engineering, Engineering, Computer Science, etc.)

Optimum Educational Attainment
Bachelor’s degree in Computer/Software, Industrial, Mechanical Engineering or Electrical Engineering

Minimum Skill and Experience Requirement
The individual must possess strong skills in the following:
• 5+ years of Computer Validation/ CSV experience within the Biotech/Biologics/Pharmaceutical/FDA regulated industries
• Thorough knowledge of cGMP/FDA regulations & work environment
• Must have strong ability to organize and manage multiple tasks in a fast-paced environment
• Demonstrated understanding and hands-on experience reviewing technical documents, including, validation documents, IQ/OQ/PQ validation protocols and reports
• Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills

Optimum Skills or Background
Knowledge of or experience with the following will lead to job success:
• GAMP (Good Automated Manufacturing Practices) training
• Validation Test Script authoring highly desirable
• CSV Certification a plus

GENERAL WORKING CONDITIONS

Location
Tampa, FL

Equal Opportunity Employment M/F/D/V


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