Validation Engineer Lab Operations & SOP Documentation

Katalyst-Healthcares-; Foster City (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst-Healthcares- seeks a capable Technical Writer to own SOPs, Lab Operations documentation, and work instructions. The role focuses on developing, maintaining, and improving process documentation for new technologies and operational workflows on site.

The ideal candidate will translate complex concepts into clear documentation, collaborate with vendors, engineers, and LabOps, and ensure compliance, accuracy, and usability across all documents.

Qualifications

• Bachelor's degree in technical writing, communications, engineering, life sciences, information technology, or related field.
• 5+ years of technical writing experience in a laboratory, operations, engineering, manufacturing, or technology environment.
• Demonstrated experience developing SOPs, process documentation, and operational procedures.
• Strong ability to translate complex technical concepts into clear, concise documentation.
• Experience working directly with vendors and subject matter experts.
• Excellent written, verbal, interpersonal, and organizational skills.
• Proficiency with Microsoft Office Suite, SharePoint, and document management systems.
• Experience supporting Lab Operations, R&D, manufacturing, pharmaceutical, biotech, or technology organizations.
• Knowledge of document control, change management, and quality management processes.
• Experience with Visio, Lucidchart, Confluence, Jira, or similar documentation tools.
• Familiarity with regulated environments and compliance requirements.

Responsibilities

• Serve as the primary documentation resource for Lab Operations and technical initiatives.
• Collaborate with vendors, engineers, lab personnel, and SMEs to gather technical information and document processes.
• Create, update, and maintain SOPs, work instructions, process flows, technical guides, and operational documentation.
• Develop documentation for new technologies, equipment deployments, and laboratory processes.
• Standardize documentation formats, templates, and naming conventions across teams.
• Conduct interviews, workshops, and process walkthroughs to capture business and technical requirements.
• Ensure documentation is accurate, version-controlled, and compliant with organizational standards.
• Review and revise existing documentation to improve clarity, consistency, and usability.
• Support audits, compliance reviews, and operational readiness activities by maintaining current documentation.
• Manage document repositories and ensure timely updates as processes evolve.

Skills

SOP development

Process mapping

Vendor collaboration

Stakeholder engagement

Document control

Education

Bachelor's degree in Technical Writing or related field

Tools

Visio

Lucidchart

Confluence

Jira

SharePoint

Job description

Position Summary:

We are seeking a highly skilled and detail-oriented Technical Writer to serve as the primary owner of operational and technical documentation. This role will be responsible for developing, maintaining, and improving Standard Operating Procedures (SOPs), Lab Operations documentation, work instructions, and process documentation for new technologies and operational workflows. The successful candidate will work onsite Monday through Friday, partnering closely with vendors, engineers, LabOps personnel, and project teams to ensure documentation is accurate, compliant, and user-friendly.

Roles and Responsibilities:

• Serve as the primary documentation resource for Lab Operations and technical initiatives.
• Collaborate with vendors, engineers, lab personnel, and subject matter experts (SMEs) to gather technical information and document processes.
• Create, update, and maintain SOPs, work instructions, process flows, technical guides, and operational documentation.
• Develop documentation for new technologies, equipment deployments, and laboratory processes.
• Standardize documentation formats, templates, and naming conventions across teams.
• Conduct interviews, workshops, and process walkthroughs to capture business and technical requirements.
• Ensure documentation is accurate, version-controlled, and compliant with organizational standards.
• Review and revise existing documentation to improve clarity, consistency, and usability.
• Support audits, compliance reviews, and operational readiness activities by maintaining current documentation.
• Manage document repositories and ensure timely updates as processes evolve.

Education and experience:

• Bachelor's degree in Technical Writing, Communications, Engineering, Life Sciences, Information Technology, or related field; or equivalent experience.
• 5+ years of technical writing experience in a laboratory, operations, engineering, manufacturing, or technology environment.
• Demonstrated experience developing SOPs, process documentation, and operational procedures.
• Strong ability to translate complex technical concepts into clear, concise documentation.
• Experience working directly with vendors and technical subject matter experts.
• Excellent written, verbal, interpersonal, and organizational skills.
• Strong attention to detail and document quality.
• Proficiency with Microsoft Office Suite, SharePoint, and document management systems.
• Experience supporting Lab Operations, R&D, manufacturing, pharmaceutical, biotech, or technology organizations.
• Knowledge of document control, change management, and quality management processes.
• Experience with Visio, Lucidchart, Confluence, Jira, or similar documentation tools.
• Familiarity with regulated environments and compliance requirements.

Key Competencies:

• Technical documentation expertise.
• SOP development and process mapping.
• Stakeholder engagement.
• Vendor collaboration.
• Project coordination.
• Document control and governance.
• Continuous process improvement.
• Strong analytical and organizational skills.