Greetings!

We are currently hiring for the position of Engineering & Maintenance Officer.

Details:

- Location: Vapi , Gujarat

- Experience : 3-7 years of relevant experience in Engineering & Maintenance, preferably within API, pharmaceutical or regulated manufacturing.

- No Of Working Days : 6 Days

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 Master Control, 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- Track document revision history and ensure obsolete or superseded documents are withdrawn from use.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 positive documentation practices.

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