Assistant Manager - Engineering Documentation

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

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.