Job Title: Computer Systems Validation (CSV) Consultant

Location: East Coast Work from Home possibilities

Job Type: Full Time

Travel required: Yes as needed by client request.

Excellis Health Solutions, LLC, an NNIT Group Company, is a global strategic management consulting services firm, based in New Hope, PA, England, Belgium and Denmark. An industry leader in supply chain, with a focus in Pharmaceuticals and Life Sciences and a specific niche in serialization, we offer a multitude of solutions using our comprehensive knowledge and proven turnkey solutions to clients. Excellis continues to expand its markets and services to meet the ever-changing industry needs. Excellis anticipates continued growth in the United States and in Europe. 

Job brief:

We are currently seeking a Computer Systems Validation (CSV) Consultant to provide validation expertise to new and existing clients. The successful candidate will provide oversight, support packaging validations, and validation/verification of equipment and computer systems. 

Essential functions:

• Demonstrate solid understanding of FDA validation guidelines and industry best practices
• Implement policies and procedures to validate / verify equipment, computer systems, and processes in accordance with regulatory requirements and company standards
• Coordinate, direct, and lead validation efforts; Including equipment, process, and computer system validation
• Design, develop, and execute test scripts from software requirements for computer system validation
• Generate, execute, review, and complete validation documentation required (Traceability Matrix, URS, IQ/OQ/PQ protocols, and summary reports)
• Compile and analyze validation data and maintain validation documentation
• Facilitate and/or support validation training, change control, periodic review of validated systems, equipment, and processes
• Interface with management personnel to represent QA/Validation in project teams with the objective to assure that project quality objectives are met
• Provide technical decision making regarding cGMP compliance, regulatory issues, validation strategy, and quality systems and/or strategic activities
• Conduct root cause analysis, prepare technical investigative reports and formulate recommendations for disposition and actions related to product non-conformance

Experience:

• 5 years of experience in highly regulated environment (Medical device, pharmaceutical, etc.) is preferred
• Strong validation skills with demonstrated knowledge within the areas of equipment / process /computer system validations and quality assurance
• In-depth understanding of cGMPs, ISO 13485, GAMP, 21 CFR Part 11 and current industry / FDA compliance
• Excellent communication (verbal and written), teamwork, and organizational skills
• Ability to develop and meet project schedules, along with contingency plans

Education:

• Bachelor’s degree in a technical discipline is required

Benefits:

Full benefits package includes low employee contribution to health care costs; Free Dental, STD/LTD Insurance, and Life Insurance. Vacation time.

Flexible schedule based on client needs.

*U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor at this time.