Validation Analyst

Key Responsibilities

Documentation Development

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

Validation Activities

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

Quality & Compliance

1. Ensure documents meet compliance expectations and follow controlled document formats.
2. Participate in internal audits, addressing document‑related findings.
3. Monitor documentation lifecycle, version control, and archival.

Collaboration & Review

1. Work closely with SMEs, QA, Engineering, IT, and Operations teams to gather information and update documents.
2. Review documentation created by peers, provide constructive feedback.
3. Manage review cycles, approvals, and change control processes.

Required Skills & Qualifications

1. Bachelor’s degree in engineering, Life Sciences, Technical Writing, English, or related field.
2. 3–8 years of experience in technical writing or documentation, with at least 2–3 years in validation (equipment, process, or software).
3. Strong understanding of validation processes such as IQ/OQ/PQ, CSV (Computer System Validation), or related methodologies.
4. Excellent written communication, grammar, and document structuring skills.
5. Experience working in regulated environments (Pharma, Biotech, Medical Devices, IT Compliance, Manufacturing, etc.).
6. Familiarity with Document Management Systems (Veeva, Jira, Confluence, SharePoint, etc.).

Preferred Qualifications

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

Soft Skills

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