Job Description

PRIMARY PURPOSE: 

Formulated Solutions is seeking a Validation Engineer to own system validation activities across the company. This role's initial and primary focus will be the validation of the eBR (electronic Batch Record) system as FS transitions manufacturing lines from paper batch records to eBR. The Validation Engineer will build and maintain the User Requirements Specification / Requirements Traceability Matrix (URS/RTM), coordinate the documentation and sign-off process across internal stakeholders and customers, and ensure that all validation work is complete, defensible, and audit-ready. This role will also lead the transition of FS's validation program off of Excel-based tracking and onto a dedicated validation management tool. As FS's validation program matures, this role will expand to cover validation of other systems and equipment across FS sites.

MAJOR DUTIES AND RESPONSIBILITIES:

eBR Validation & URS/RTM Ownership

• Own and maintain the URS/RTM (User Requirements Specification / Requirements Traceability Matrix) Excel workbook for eBR validation projects.
• Review existing paper batch records and work with Operations and Quality to capture and document the underlying requirements in the URS/RTM.
• Trace each captured requirement through to its corresponding test case and result, maintaining the RTM as the source of truth for requirement coverage.
• Keep the URS/RTM current as requirements change, and use it as the traceability backbone for validation testing and sign-off.
• Lead the evaluation and adoption of a dedicated validation management tool, driving FS's transition away from Excel-based URS/RTM tracking toward a purpose-built system.

Validation Documentation & Sign-Off

• Oversee preparation of Management of Change (MOC) documentation and shepherd each MOC through internal and customer approval.
• Own the Configuration Specification documentation for validated systems, ensuring it accurately reflects the as-built configuration.
• Author and manage the Validation Summary Report for each validation effort, consolidating testing results and open items.
• Draft User Acceptance Test (UAT) scripts, dry-run them internally ahead of formal execution, and lead execution of UATs with internal stakeholders and customers.
• Track outstanding sign-offs across all validation documents and proactively follow up with internal approvers to keep projects moving.

Customer Coordination

• Serve as a primary point of contact with customers (e.g., Bayer) on validation documentation and approvals.
• Package and submit validation documentation to customers in the format and process they require, and follow up to obtain timely customer sign-off.
• Communicate validation status, risks, and timelines clearly to both internal leadership and customer counterparts.

Broader System Validation

• Serve as the company-wide owner for system validation, extending validation practices beyond eBR to other systems and equipment as priorities dictate.
• Perform risk assessments and validation testing for system upgrades and patches to validated systems, ensuring continued compliance and audit-readiness.
• Conduct internal periodic reviews of validated systems to confirm they remain in a validated state and to identify any drift requiring remediation.
• Help establish and continuously improve FS's validation processes, templates, and standard practices.
• Support internal and customer audits by ensuring validation documentation is organized, complete, and readily accessible.

QUALIFICATION: 

Required:

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical field, or equivalent hands-on validation experience.
• 3+ years of experience in validation or quality systems within a regulated manufacturing environment (pharmaceutical, consumer health, medical device, or similar GxP setting).
• Working knowledge of computer system validation (CSV) / Computer Software Assurance (CSA) concepts and documentation — URS, risk assessment, Configuration Specification, IQ/OQ/PQ, and Validation Summary Reports.
• Familiarity with data integrity principles (ALCOA+) and applicable regulations such as FDA 21 CFR Part 11 and cGMP.
• Strong Excel skills, with experience building and maintaining detailed tracking workbooks such as a URS/RTM.

Preferred:

• Direct experience validating an electronic batch record (eBR) or MES platform (e.g., Tempo/Werum PAS-X or similar) in a manufacturing environment.
• Experience working directly with customers or external auditors on validation deliverables and sign-off.
• Familiarity with Management of Change (MOC) / change control processes in a GxP environment.
• Experience in contract manufacturing or a multi-site manufacturing organization.
• Experience selecting, implementing, or administering a dedicated validation management or quality management software tool.
• Excellent written communication and documentation skills; comfortable authoring formal validation deliverables.
• Strong organizational skills and the ability to manage multiple documents, approvals, and stakeholders concurrently.