Senior CSV Validation Specialist

MatchPoint Solutions is a fast-growing young energetic global IT-Engineering services company with clients across the US. We provide technology solutions to various clients like Uber Robinhood Netflix Airbnb Google Sephora and more! More recently we have expanded to working internationally in Canada China Ireland UK Brazil and India. Through our culture of innovation we inspire build and deliver business results from idea to outcome. We keep our clients on the cutting edge of the latest technologies and provide solutions by using industry-specific best practices and expertise.

We are excited to be continuously expanding our team. If you are interested in this position please send over your updated resume. We look forward to hearing from you!

Job Title: Senior CSV Validation Specialist

Onsite: Indianapolis IN USA
6months

Rate: 80$-85$/hr on W2

Responsibilities:

• Lead the Building Management System validation lifecycle across all buildings from User Requirement Specification authoring through Validation Summary Report and closeout.
• Author and obtain approval for User Requirement Specifications for the Johnson Controls Metasys Building Management System platform.
• Partner with Johnson Controls International to review and accept Software Requirement Specifications.
• Develop and execute Design Qualification Installation Qualification Operational Qualification and Performance Qualification protocols using a risk based approach aligned with quality procedures.
• Generate and maintain Requirements Traceability Matrices linking requirements through design testing and acceptance.
• Author Validation Summary Reports documenting validation activities deviations resolutions and acceptance rationale.
• Perform 21 CFR Part 11 gap assessments for electronic records electronic signatures and audit trail compliance across Metasys and AVEVA PI systems.
• Coordinate with Integration Engineering resources to support alarm management validation aligned with ISA 18.2 and operational technology cybersecurity validation aligned with ISA IEC 62443.
• Validate OPC UA integrations between Metasys AVEVA PI and DeltaV QBMS.
• Draft commissioning protocols and support system acceptance testing activities.
• Draft 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 support ongoing maintenance of the validated state.
• Support audit readiness activities by ensuring validation documentation is inspection ready and aligned with FDA EMA and corporate quality standards.
• Provide additional support for data integrity assessments commissioning and qualification activities remediation of validation findings and validation strategy development for future system upgrades as needed.

Required qualifications

• Demonstrated experience performing computer systems validation for building management automation or control systems within a pharmaceutical or GMP regulated environment.
• Strong working knowledge of GAMP 5 methodology V model lifecycle concepts and risk based validation approaches.
• Hands on experience supporting 21 CFR Part 11 compliance assessments for electronic records electronic signatures and audit trails.
• Proven ability to author and execute validation deliverables including Validation Plans User Requirement Specifications Functional Specifications Design Specifications Installation Qualification Operational Qualification Performance Qualification Requirements Traceability Matrices and Validation Summary Reports.
• Experience supporting Building Management Systems Distributed Control Systems Programmable Logic Controllers Human Machine Interfaces or historian platforms in manufacturing environments.
• Solid understanding of FDA and EMA regulatory expectations related to computerized system validation.

Preferred qualifications

• Direct experience validating Johnson Controls Metasys Honeywell Siemens or similar Building Management System platforms.
• Experience validating AVEVA PI Historian DeltaV systems or OPC UA integrations.
• Familiarity with ISA 18.2 alarm management principles and ISA IEC 62443 cybersecurity standards.
• Knowledge of data integrity principles including ALCOA plus and data governance practices.
• Experience using electronic validation management systems such as Kneat or ValGenesis.
• Life sciences or pharmaceutical manufacturing experience preferably supporting biologics advanced therapies or greenfield facility start up and commissioning efforts.
• Proficiency using Microsoft Word Excel and Visio to produce and maintain validation documentation and diagrams.
• Tools and Technologies:
• Johnson Controls Metasys Building Management System
• AVEVA PI Historian
• DeltaV QBMS
• OPC UA integration technologies
• Electronic validation management systems
• Microsoft Word Excel and Visio

MatchPoint Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.

This policy applies to all terms and conditions of employment including recruiting hiring placement promotion termination layoff recall transfer leaves of absence compensation and training.