At least 5 years
The Senior CSV Engineer leads the computer system validation workstream for the implementation of a Tempo-MES electronic batch record (EBR) system. This role owns the validation project for the EBR implementation, ensuring that all site-specific deliverables meet GxP, data integrity, and electronic records/signatures requirements. The position requires a strong blend of technical validation expertise, manufacturing systems knowledge, and cross-functional collaboration to deliver a fully validated, compliant, and fit-for-purpose MES/EBR solution.
Responsibilities- Lead the computer system validation workstream for the Tempo-MES electronic batch record system implementation and ensure all required site deliverables are completed on time and to the required quality.
- Develop and maintain the Project Validation Plan, clearly defining the validation strategy, scope, lifecycle deliverables, responsibilities, review and approval roles, execution approach, acceptance criteria, phase entry and exit criteria, and closeout requirements.
- Create a site-specific User Requirements Specification (URS) that documents site-specific business processes, workflows, operational requirements, user groups, roles, approval requirements, devices, interfaces, and site use cases.
- Perform and maintain a comprehensive risk assessment covering system requirements and intended use, identifying GxP-critical requirements, risk scenarios, and required controls.
- Author, route, execute, and close risk-based Installation/Operational Qualification (IOQ) protocols or scripts for requirements assigned to qualification testing, verifying environment-specific configuration in Tempo validation and production environments.
- Author, route, execute, and close risk-based Performance Qualification (PQ) protocols or scripts to demonstrate that site business processes can be successfully executed using the configured system, workflows, and user roles.
- Verify batch and procedure template configuration, including completion logic, required fields, data-entry requirements, calculations, checks, and applicable attachments, to ensure they support compliant and efficient operations.
- Verify the Batch Template lifecycle from Draft through Effective status using configured user groups, including Batch Run creation through Send to Execution and Batch Run progression from Procedure Run Approval through Release.
- Verify role-based approvals, permissions, segregation of duties, and electronic signatures using site-specific user groups to ensure compliance with electronic records and signatures regulations.
- Initiate, investigate, assess, correct, route, and close validation deviations or discrepancies, obtaining all required approvals prior to retesting.
- Develop and maintain end-to-end traceability from site and applicable global requirements through risk assessment, design and configuration controls, IOQ/PQ test coverage, deviations, and final results.
- Prepare the Validation Summary Report documenting executed scope, approved deliverables, testing results, deviations and retests, traceability status, residual risks, open items, and the overall validation conclusion.
- Coordinate with cross-functional stakeholders, including manufacturing, quality, IT, and system owners, to align requirements, testing activities, and approvals.
- Provide subject matter expertise on CSV, MES/EBR validation, and data integrity principles, and support audits or inspections related to the system implementation.
- Minimum five years of hands-on computer system validation (CSV) experience in a GxP pharmaceutical or biotechnology manufacturing environment.
- Demonstrated experience validating Manufacturing Execution Systems (MES) or electronic batch record (EBR) systems in a regulated setting.
- Proficiency in developing and executing Project Validation Plans, User Requirements Specifications (URS), risk assessments, traceability matrices, IOQ/PQ protocols, deviations/retests, and validation summary reports.
- Strong working knowledge of Good Manufacturing Practice (GMP) requirements and GxP expectations for computerized systems.
- Experience with electronic records and electronic signatures, including data integrity principles, audit trails, role-based access, and end-to-end workflow testing.
- Hands-on experience with risk-based validation approaches, including application of GAMP 5 principles or similar risk-based frameworks.
- Strong technical writing skills with the ability to produce clear, complete, and inspection-ready validation documentation.
- Proven ability to conduct thorough investigations and manage deviations and retests in a structured, compliant manner.
- Demonstrated capability in project coordination, including planning, organizing, and tracking validation activities.
- Effective cross-functional communication skills, with the ability to collaborate with stakeholders from quality, manufacturing, IT, and other functions.
- Practical experience with MES, validation, CSV, electronic records, and URS/IOQ activities in a regulated environment.
- Prior hands-on experience with the Tempo-MES platform is preferred.
- Relevant experience with integrations involving MES or EBR systems is desirable.
- Experience owning or leading an EBR implementation validation project is an advantage.
- Optional sanitized writing sample or representative list of validation deliverables may be requested, where permitted, to demonstrate documentation quality.
- Strong attention to detail and a structured approach to documentation, testing, and traceability.
- Ability to work independently with minimal supervision while managing multiple validation tasks and priorities.
This role primarily operates on-site at a technical center in North Carolina, supporting a large pharmaceutical manufacturing environment. On-site presence is expected; however, qualified remote candidates may be considered. Approved remote resources must remain available during standard business hours, use secure access methods, support scheduled testing and reviews, and travel to the site when required. The position typically requires approximately 40 hours of support per week. The work involves close collaboration with manufacturing, quality, and IT teams and regular interaction with MES and validation tools in a controlled, GxP-compliant environment.
Job Type & LocationThis is a Contract position based out of Sanford, NC.
Pay and BenefitsThe pay range for this position is $65.00 - $90.00/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace TypeThis is a fully onsite position in Sanford,NC.
Application DeadlineThis position is anticipated to close on Oct 20, 2026.
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Posting ID: JP-006333091