Officer / Sr. Officer / Executive (E&M)

Key Responsibilities

1. Equipment & Facility Documentation

·    Maintain and control engineering drawings, P&IDs (Piping & Instrumentation Diagrams), equipment manuals and spare parts lists.

·    Manage equipment qualification documentation including IQ, OQ and PQ records, and maintain requalification schedules.

·    Create, update and maintain equipment files, asset registers and technical specifications.

2. Maintenance Documentation

·    Develop, maintain and periodically review Preventive Maintenance (PM) procedures and schedules.

·    Prepare, revise and control Standard Operating Procedures (SOPs) for maintenance and engineering activities.

·    Maintain work orders, maintenance logs and complete equipment history records.

·    Document corrective maintenance and breakdown maintenance activities in the CMMS (Computerized Maintenance Management System).

3. GMP & Regulatory Compliance

·    Ensure engineering and maintenance documentation is aligned with applicable cGMP requirements for API manufacturing, including 21 CFR Part 211 and ICH Q7 expectations.

·    Support preparation, retrieval and review of engineering documentation for regulatory and customer audits, including FDA, EMA and WHO inspections/audits.

·    Maintain calibration program documentation for instruments, gauges and sensors.

·    Prepare and manage change control documentation for engineering modifications.

·    Participate in deviation investigations and CAPA documentation related to equipment failures and maintenance issues.

4. Document Control & Management

·    Control the complete document lifecycle: creation, review, approval, distribution, revision, retrieval and archiving.

·    Maintain records in applicable document management systems (DMS/EDMS), such as Veeva, Documentum or MasterControl, where deployed.

·    Track document revision history and ensure obsolete or superseded documents are withdrawn from use.

·    Coordinate document review and approval cycles with Engineering, Production, Quality Assurance and Validation teams.

5. Validation & Qualification Support

·    Prepare and compile Validation Master Plan (VMP) inputs, qualification protocols and qualification/validation summary reports as applicable.

·    Support Computer System Validation (CSV) documentation for engineering-related software and computerized systems.

·    Maintain qualification records for critical utilities such as HVAC, WFI, purified water, compressed air and steam, as applicable to the site.

6. Spare Parts & Vendor Documentation

·    Maintain vendor and supplier technical documents, drawings, manuals and certificates.

·    Maintain critical spare parts lists with OEM specifications and relevant technical details.

·    File and track equipment warranties, service contracts and associated technical/service documentation.

7. Cross-Functional Coordination

·    Liaise with Quality Assurance, Production, EHS and Validation teams for document review, approval and implementation.

·    Support internal, regulatory and customer audits by providing requested engineering and maintenance documents and records.

·    Train engineering and maintenance personnel on applicable documentation procedures and good documentation practices.