Position Overview:
The Senior Computer Systems Validation Specialist focused on Building Management Systems to support a regulated pharmaceutical manufacturing environment. The specialist will support a Site Automation Engineering organization and collaborate closely with automation engineers, IT, system integrators, and site leadership within a GMP-regulated environment.
Responsibilities:
- Lead the Building Management System validation lifecycle across multiple manufacturing buildings from User Requirement Specification authoring through validation closeout.
- Author and obtain approval for User Requirement Specifications for the Metasys Building Management System platform.
- Partner with the Building Management System vendor on Software Requirement Specification review and acceptance.
- Develop and execute Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification protocols using a risk-based approach aligned with site quality procedures.
- Generate and maintain requirements traceability matrices linking requirements through design, testing, and acceptance.
- Author Validation Summary Reports documenting validation activities, deviations, resolution, and acceptance rationale.
- Perform twenty one CFR Part eleven gap assessments related to electronic records, electronic signatures, and audit trail compliance for Metasys and AVEVA PI systems.
- Coordinate with integration engineering resources on alarm management validation aligned with ISA eighteen point two and operational technology cybersecurity validation aligned with ISA IEC sixty two four four three.
- Validate OPC UA integrations between Metasys, AVEVA PI, and DeltaV quality Building Management System.
- Draft commissioning protocols and support system acceptance testing activities.
- Develop and maintain standard operating procedures related to Building Management System operations, operator training, and preventive maintenance.
- Enroll validated systems into the periodic review program to maintain validated state.
- Support audit readiness activities by ensuring validation documentation is inspection ready and aligned with FDA, EMA, and corporate quality standards.
- Provide support for data integrity assessments across Building Management System and historian platforms as needed.
- Assist with commissioning and qualification activities for new Building Management System equipment and system expansions.
- Support remediation efforts related to validation findings from internal audits or regulatory inspections.
- Advise stakeholders on validation strategy for future Building Management System upgrades and expansions.
- Provide support to additional resources or overflow activities during peak Phase three qualification execution.
Qualifications:
- Bachelor's degree in engineering, computer science, life sciences, or a related technical discipline or equivalent industry experience.
- Extensive experience performing computer systems validation in a regulated pharmaceutical manufacturing environment.
- Demonstrated expertise validating Building Management Systems, preferably Metasys.
- Strong working knowledge of GxP, GMP, FDA and EMA regulatory expectations.
- Experience authoring and executing qualification protocols and validation documentation.
- Working knowledge of twenty one CFR Part eleven, data integrity principles, and audit readiness.
- Experience with alarm management standards and operational technology cybersecurity frameworks.
- Ability to work onsite daily in a manufacturing environment.
- Strong communication skills with the ability to collaborate across engineering, IT, and quality organizations.
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EXOS (formerly Sondhi Solutions)