Assistant Manager - Engineering Documentation

RXinsider LTD.; Visakhapatnam; On-site; INR 1,400,000 - 2,000,000; Full time

Job summary

RXinsider LTD. is seeking a senior professional to manage and control engineering documentation for facilities, HVAC, utilities, and equipment in a GMP setting. You will coordinate with QA, Production, Projects, and vendors to ensure timely, compliant documentation from initiation through commissioning and validation.

The role demands 10–12 years in engineering documentation within pharma/ API environments, strong attention to detail, and proficiency with document-management systems.

Qualifications

• Experience with GMP documentation, qualification, validation, and audit requirements.
• Strong knowledge of engineering documentation and document-control practices.
• Excellent coordination and communication skills.

Responsibilities

• Prepare, review, update, and maintain engineering documents, records, and reports.
• Manage documentation related to HVAC, utilities, equipment, facilities, and projects.
• Prepare and maintain SOPs, specifications, protocols, drawings, and qualification documents.
• Coordinate with Engineering, QA, Production, Projects, Validation, and external vendors.
• Review documents for accuracy, traceability, and compliance with procedures.
• Support documentation for DQ/IQ/OQ/PQ, commissioning, qualification, and validation activities.
• Maintain document numbering, revision control, approval, issuance, archival, and retrieval.
• Review vendor documents, drawings, manuals, test certificates, and dossiers.
• Ensure records comply with GMP and data integrity requirements.
• Support audits by providing engineering documentation and evidence.
• Track status and follow up for closure of pending documents.
• Maintain an organized repository and archival of obsolete documents.
• Participate in projects providing documentation support from initiation to commissioning.

Skills

Engineering documentation

GMP documentation

Document-control

Coordination

Attention to detail

MS Office

Education

B.Tech / B.E.

M.Tech / MS

Tools

MS Office

Document-management systems

Job description

Description

JOB 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

• Bachelors Degree (BA/BS) B.Tech - Required
• Master Degree (MS/MA) M.Tech - Preferred

Experience:

• 5 years or more in 5 - 8 Years