Validation Technical Writer - Process Alliance : Job Details

About the Role

We are seeking a detail-oriented Validation Technical Writer with 1–5 years of experience to support Computer System Validation (CSV) efforts in a regulated environment. This role is responsible for drafting, updating, and managing validation documentation in alignment with project and compliance standards. The ideal candidate will be skilled in document management systems, comfortable working across teams, and able to clearly communicate technical information. Experience with Kneat is a plus.

Responsibilities

• Deliver New System Validation [new systems and updates under change management]
• Read and understand Validation Plan and Test Plan
• Support validation efforts as per Validation Plan and Computer System Validation (CSV) document management plan expectations

Manage CSV Documentation

• Assist with the directed drafts and updates of validation deliverables
• Create and maintain area/project style template
• Update and maintain validation deliverable templates
• Ensure document updates align with project style template
• Ensure documents align with deliverable template
• Route validation artifacts for review and approval in the electronic document management system, incorporating review feedback
• Ensure all naming conventions and metadata align with document management plan
• Route testing artifacts for review and approval in the test management system, incorporating review feedback
• Apply available views, reports and queries to support project tracking
• Communicate document review/approval status
• Scan and route Executed Documents, where applicable
• Collaborate with Validation Lead to upload and update test templates in the electronic test system
• Assemble test sets in the electronic test system
• Assist SMEs with editing issues in Microsoft Office
• Assist with updating of spreadsheets, lists, and SharePoint sites as directed
• Maintain Validated State of Systems

Change Control

• Read and develop familiarity with intent and content of change controls assigned for support
• Support all CSV documents associated with the change control in alignment with CSV document management plan expectations
• Audit summary of updated documents according to document management practices, e.g., electronic document list report, as requested

Security

• Support routing and applications for System Access

Add High Value to Validation Process

• Maintain 100% training compliance
• Complete all tasks within specified timelines
• Contribute to a culture of high reliability of CSV process steps
• Receive direction from multiple team resources

Qualifications

• Four-year degree required, in a technical subject preferred
• Attention to detail in complex tasks
• Experience with Microsoft Office software
• Quick learner, comfortable with web-based applications (e.g., change management and document management systems)
• 1–5 years of validation experience
• Kneat experience is a plus

About Our Culture:

At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.

Learn more about us:

Visit our website at www.processalliance.com to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.