• Minimum 8+ years of experience in Computer system validation with solid understanding of Good Manufacturing Practice (GMP) regulations.

• Candidates with experience on Siemens S7 PLC controllers, WinCC Unified HMI Scada and commissioning/qualification would be ideal.

• Solid understanding of the variety of these types of computerized systems to qualify systems which impact cGMP operations using a risk based methodology

• Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met

• Evaluate proposed changes to validated computer systems and recommend level of validation activities required

• Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan

• Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans

• Execution of validation plans and validation documents

• Able to work collaboratively and in a client focused environment. Have the highest standards for quality, accuracy, and professionalism

• Be highly motivated, organized, and able to manage priorities. Have excellent communication, presentation, and interpersonal skills