Description:
Responsible for managing, reviewing, maintaining, and controlling engineering documentation related to facilities, utilities, equipment, HVAC, and engineering projects in compliance with applicable GMP, quality, and documentation requirements.
Key Responsibilities
- Prepare, review, update, and maintain engineering documents, records, and reports.
- Manage documentation related to HVAC, utilities, equipment, facilities, and engineering projects.
- Prepare and maintain engineering SOPs, specifications, protocols, reports, drawings, checklists, logbooks, and qualification documents.
- Coordinate with Engineering, QA, Production, Projects, Validation, and external vendors for timely completion of documentation.
- Review engineering documents for accuracy, completeness, traceability, and compliance with approved procedures.
- Support preparation and execution documentation for DQ, IQ, OQ, PQ, commissioning, qualification, and validation activities.
- Maintain documentation for change controls, deviations, CAPA, risk assessments, and engineering modifications.
- Ensure proper document numbering, revision control, approval, issuance, archival, and retrieval.
- Review vendor documents, drawings, manuals, test certificates, and technical dossiers.
- Ensure engineering records are maintained in accordance with GMP and data-integrity requirements.
- Support internal, customer, and regulatory audits by providing engineering documentation and evidence.
- Track documentation status and follow up with concerned departments for closure of pending documents.
- Maintain an organized engineering document repository and ensure timely archival of obsolete documents.
- Participate in engineering projects and provide documentation support from project initiation through commissioning and qualification.
Qualification
- B.Tech / B.E. in Mechanical, Electrical, or relevant Engineering discipline.
- Candidates with relevant pharmaceutical engineering documentation experience will be preferred.
Required Experience & Skills
- 10–12 years of overall experience in engineering documentation, preferably in the pharmaceutical/API manufacturing industries
- Strong knowledge of engineering documentation and document-control practices.
- Experience with GMP documentation, qualification, validation, and audit requirements.
- Good understanding of HVAC, utility systems, equipment, and facility-related documentation.
- Good coordination and communication skills.
- Strong attention to detail and ability to maintain document accuracy and traceability.
- Working knowledge of MS Office and document-management systems.
Qualifications
Education:- Bachelors Degree (BA/BS) B.Tech - Required
- Master Degree (MS/MA) M.Tech - Preferred
Experience:- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses: