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SR. CSV Specialist

EXOS (formerly Sondhi Solutions)

Indianapolis, IN

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JOB DETAILS
SKILLS
Acceptance Testing, Automation Engineering, Biology, Blackjack, Code Reviews, Code of Federal Regulations, Commissioning, Communication Skills, Computer Science, Computer Systems, Data Analysis, Data Quality, DeltaV, Drug Manufacturing, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), GxP, ISA Standards, Information Technology & Information Systems, Internal Audit, International Electro-Technical Commission (IEC), Internet Security, Leadership, Management Strategy, Manufacturing, Preventative Maintenance, Property Management, Quality Management, Quality Metrics, Regulations, Risk, Software Specification, Standard Operating Procedures (SOP), Standards Development, System Integration (SI), System Lifecycle, System Operations, System Test, System Validation, Systems Administration/Management, Team Player, Test Design, Traceability, Validation Documentation, Validation Plan, Writing Skills
LOCATION
Indianapolis, IN
POSTED
20 days ago
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.

About the Company

E

EXOS (formerly Sondhi Solutions)

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