Computer Systems Validation Engineer

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!

Computer Systems Validation Engineer
Indianapolis IN - onsite
6 Months
Pay rate: $65 - $70/hr on W2

The Computer Systems Validation Engineer supports validation lifecycle activities for automation and control systems within a regulated pharmaceutical manufacturing environment. This role partners closely with Automation Information Technology and site leadership to ensure systems remain compliant validated and inspection ready in alignment with regulatory and corporate quality expectations. This is an onsite role supporting daily operations at a customer manufacturing location.

Responsibilities:

• Lead validation lifecycle activities for automation and control systems including distributed control systems programmable logic controllers human machine interfaces and historian platforms.
• Develop and execute validation plans user requirement specifications functional specifications design specifications and configuration specifications.
• Author and execute installation qualification operational qualification and performance qualification protocols.
• Generate and maintain requirements traceability matrices linking requirements through design testing and acceptance.
• Author validation summary reports documenting outcomes deviations and acceptance rationale.
• Perform 21 CFR Part 11 gap assessments for electronic records electronic signatures and audit trail compliance.
• Conduct risk assessments including GAMP 5 categorization and functional risk assessments.
• Manage validation change control by assessing system changes patches and upgrades and determining revalidation requirements.
• Support periodic reviews to confirm systems remain in a validated state and documentation remains current.
• Define and execute computer systems validation scope for the ServiceNow platform in collaboration with process owners.
• Validate integrations between automation platforms and ServiceNow including event connectors configuration management database connectors application programming interfaces and access provisioning workflows.
• Draft and maintain standard operating procedures related to computer systems validation.
• Support audit readiness activities and ensure documentation aligns with regulatory and corporate quality standards. Qualifications:
• Demonstrated experience performing computer systems validation for automation and control systems in a pharmaceutical or GMP regulated environment.
• Strong knowledge of GAMP 5 methodology V model lifecycle and risk based validation approaches.
• Experience with 21 CFR Part 11 compliance including electronic records electronic signatures and audit trail requirements.
• Proficiency developing validation deliverables across the system development life cycle.
• Experience supporting distributed control systems programmable logic controllers human machine interfaces or historian systems in manufacturing.
• Strong understanding of FDA and EMA expectations for computerized system validation. Preferred
• Experience validating DeltaV PI Historian Rockwell FactoryTalk or Metasys platforms.
• Experience validating ServiceNow or other IT service management platforms in a GxP context.
• Familiarity with data integrity principles including ALCOA plus.
• Experience with electronic validation management systems such as Kneat or ValGenesis.
• Pharmaceutical or life sciences manufacturing experience including biologics or advanced therapies.
• Tools and Technologies:
• Distributed control systems and automation platforms
• Programmable logic controllers and human machine interfaces
• Historian systems
• ServiceNow
• 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.