Validation Lead

Navikenz; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Navikenz in Bengaluru is looking for a Senior Technical Writer with over 12 years of experience, specifically in validation documentation. The role requires creating high-quality, structured documents such as SOPs and Validation Protocols.

The ideal candidate will have a Bachelor's degree in engineering or a related field, along with a strong grasp of validation processes like IQ/OQ/PQ. Experience in regulated environments, strong communication skills, and proficiency in Document Management Systems are essential.

Qualifications

• 12+ years of experience in technical writing, with at least 6+ years in validation.
• Strong understanding of validation processes such as IQ/OQ/PQ.
• Experience working in regulated environments like Pharma, Biotech.

Responsibilities

• Create and maintain technical documents including SOPs and Validation Protocols.
• Develop validation protocols and reports for systems and software applications.
• Ensure documents meet compliance expectations and adhere to controlled formats.

Skills

Technical writing

Validation processes (IQ/OQ/PQ)

Document Management Systems (e.g., Veeva, Jira)

Excellent written communication

Regulated environments

Education

Bachelor’s degree in engineering, Life Sciences, Technical Writing, or related field

Tools

Veeva

Jira

Confluence

SharePoint

Job description

• Create and maintain technical documents including SOPs, Work Instructions, Validation Protocols (IQ/OQ/PQ), Reports, User Manuals, and Process Documentation.
• Draft high-quality, structured documents aligned with internal standards and regulatory requirements.
• Ensure clarity, accuracy, and consistency in all documentation materials.

Validation Activities

• Develop validation protocols and reports for systems, equipment, processes, and software applications.
• Support execution of validation activities, documenting deviations and ensuring traceability.
• Maintain validation documentation in accordance with compliance guidelines (e.g., GxP, ISO, FDA, EU Annex standards where applicable).

Quality & Compliance

• Ensure documents meet compliance expectations and follow controlled document formats.
• Participate in internal audits, addressing document‑related findings.
• Monitor documentation lifecycle, version control, and archival.
• Work closely with SMEs, QA, Engineering, IT, and Operations teams to gather information and update documents.
• Review documentation created by peers, provide constructive feedback.
• Manage review cycles, approvals, and change control processes.

Required Skills & Qualifications

• Bachelor’s degree in engineering, Life Sciences, Technical Writing, English, or related field.
• 12+ years of experience in technical writing or documentation, with at least 6+ years in validation (equipment, process, or software).
• Strong understanding of validation processes such as IQ/OQ/PQ, CSV (Computer System Validation), or related methodologies.
• Excellent written communication, grammar, and document structuring skills.
• Experience working in regulated environments (Pharma, Biotech, Medical Devices, IT Compliance, Manufacturing, etc.).
• Familiarity with Document Management Systems (Veeva, Jira, Confluence, SharePoint, etc.).

Preferred Qualifications

• Knowledge of GxP, FDA 21 CFR Part 11, ISO 9001/13485, or similar standards.
• Experience supporting audits and regulatory inspections.
• Ability to translate complex technical information into user-friendly content.
• Strong analytical, attention-to-detail, and organizational skills.

Soft Skills

• Excellent communication and interpersonal abilities.
• Ability to manage multiple documentation projects simultaneously.
• Strong ownership mindset and willingness to collaborate across functions.
• Adaptable, process-driven, and quality-focused.