Lab Operations Documentation Lead - SOPs & Validation

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

Job summary

Creative Solutions Services, LLC is seeking a highly skilled Technical Writer to own SOPs, Lab Operations documentation, work instructions, and process documentation for new technologies and workflows. This on-site role collaborates with vendors, engineers, LabOps personnel, and project teams to ensure documentation is accurate, compliant, and user-friendly.

The ideal candidate will have 5+ years of technical writing experience in laboratory or technology environments, strong attention to

Qualifications

• Bachelor’s degree in a relevant field or equivalent experience.
• 5+ years of technical writing in a lab/ops/engineering/manufacturing/tech environment.
• Ability to translate complex concepts into clear documentation.
• Experience creating SOPs, process documentation, and operational procedures.
• Experience with vendors and technical SMEs.
• Excellent written and verbal communication.
• Proficiency with MS Office, SharePoint, and document management systems.
• Experience in regulated environments and compliance.
• Knowledge of Visio, Lucidchart, Confluence, Jira, or similar tools.
• Strong document control and change-management understanding.

Responsibilities

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

Skills

Technical writing

Documentation

Attention to detail

Communication

Translate complex concepts

Education

Bachelor's degree in Technical Writing, Communications, Engineering, Life Sciences, IT or related field

Tools

Visio

Lucidchart

Confluence

Jira

MS Office / 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.