• Assisting in scoping validation services
• Assist in the Writing proposals and validation Statements of Work
• Provide FDA IT Compliance guidance and awareness training to project teams
• Assist with the development of system requirements and specifications to ensure validation/Part 11 requirements are met
• Evaluate proposed changes to validated computer systems and recommend level of validation activities required
• Coordinate audits of internal computer systems validation activities, protocol and procedures, and prepare responses
• Identify and qualify all computer systems which impact GxP operations using a risk based methodology
• Develop computer systems validation plans, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
• Deep understanding of test plans, test scripts and user acceptance tests and the management of the execution of test plans
• Act as a CSV Lead for all validation projects
• Execute or oversee the execution of validation plans and validation documents
• Perform project management activities for CSV process within the scope of an overall system project
• Work with overall project manager to include validation activities in implementation timelines
• Manage internal CSV resources to facilitate completion of qualification activities
• Develop validation summary reports
• Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
• Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems

Education and Experience:

• 2 - 3 years of CSV experience in FDA regulated industry or in consulting to FDA-regulated industries
• BS degree in Computer Science, MIS, Life Sciences or Engineering is recommended
• Excellent understanding and experience with industry regulations, standards and guidelines, including GxP, 21 CFR Part 11, GAMP-5 and optionally EMA and the new CSA guidelines
• Experience in the review, evaluation and testing of systems to ensure compliance with the FDA Electronic Records/Electronic Signatures regulation and 21 CFR
• Excellent interpersonal, communication, organizational, and project management skills. Excellent presentation and writing skills.
• Supervisory/leadership experience preferred.

The firm offers a competitive benefits package, base compensation, and an employee bonus program for eligible roles based on individual and firm performance per program guidelines. Base compensation ranges can be found between the ranges noted below in the posting, and an actual offer can vary based upon on role, hiring location, and qualifications. For additional information on RSM’s total rewards, visit our website at https://rsmus.com/careers/working-at-rsm/benefits.html.

If required by applicable law or client policy, you may be required to be vaccinated for COVID-19 or have an approved accommodation.

You want your next step to be the right one. You've worked hard to get where you are today. And now you're ready to use your unique skills, talents and personality to achieve great things. RSM is a place where you are valued as an individual, mentored as a future leader, and recognized for your accomplishments and potential. Working directly with clients, key decision makers and business owners across various industries and geographies, you'll move quickly along the learning curve and our clients will benefit from your fresh perspective.

Experience RSM US. Experience the power of being understood.

RSM is an equal opportunity/affirmative action employer. Minorities/Females/Disabled/Veterans.