Engineering Officer

Engineering Officer Documentation

Department: Engineering
Industry: Pharmaceutical Manufacturing
Designation: Engineering Officer Documentation
Reporting To: Engineering Manager
Location: Sterling Healthcare LTD Talegaon Pune

Job Purpose

To maintain, control, review, and update engineering documentation in accordance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, company SOPs, and quality management system requirements. The role ensures the availability, accuracy, traceability, and proper archival of engineering documents related to plant utilities, equipment, facilities, and maintenance activities.

Key Responsibilities

Engineering Documentation Management

• Prepare, review, update, and maintain engineering documents, records, and registers.
• Maintain equipment files, equipment history cards, preventive maintenance records, and breakdown maintenance records.
• Maintain engineering SOPs, work instructions, checklists, formats, and standard maintenance procedures.
• Maintain equipment specifications, equipment manuals, drawings, P&IDs, layout drawings, and technical documents.
• Ensure proper document identification, version control, issuance, retrieval, and archival.
• Maintain both hard-copy and electronic documentation as applicable.

GMP and Regulatory Compliance

• Ensure engineering documentation complies with cGMP, applicable regulatory requirements, and internal quality procedures.
• Support internal audits, external audits, regulatory inspections, and customer audits by providing required engineering documents.
• Ensure proper completion, review, and traceability of engineering records in accordance with approved procedures.
• Follow ALCOA+ data integrity principles for applicable records and documentation.
• Coordinate with the Quality Assurance (QA) department for document approval, issuance, revision, and periodic review. Maintenance Documentation
• Maintain preventive maintenance (PM) schedules and records for manufacturing equipment, utilities, and facility systems.
• Maintain breakdown maintenance reports, equipment service records, and maintenance history.
• Track calibration records, equipment qualification documents, and requalification schedules in coordination with the responsible departments.
• Maintain records related to HVAC,AHU, compressed air, purified water, water for injection (where applicable), steam, electrical systems, and other plant utilities.
• Ensure timely documentation and closure of maintenance activities as per approved procedures.

Change Control and Deviation Management

• Assist in preparing and maintaining engineering change control documents.
• Coordinate the documentation of deviations, corrective and preventive actions (CAPA), and engineering-related investigations.
• Maintain records related to equipment installation, modification, relocation, and replacement.
• Support risk assessments and impact assessments for engineering changes.
• Track pending documentation actions and follow up with concerned departments for timely closure.

Qualification and Validation Documentation

• Maintain equipment qualification and validation documents, including DQ, IQ, OQ, and PQ, as applicable.
• Coordinate with Engineering, QA, and Validation teams for documentation review and approval.
• Maintain requalification records and supporting documents for critical equipment and utility systems.
• Ensure approved protocols, reports, and associated records are properly filed and retrievable.

Document Control and Coordination

• Coordinate with QA, Production, Warehouse, QC, Validation, and other relevant departments for engineering documentation.
• Maintain document master lists, revision histories, document trackers, and archival indexes.
• Ensure obsolete documents are withdrawn from points of use in accordance with document control procedures.
• Prepare periodic documentation status reports and follow up on overdue records.
• Maintain confidentiality, accuracy, and traceability of controlled documents.

Qualification

• Diploma or Bachelors degree in Mechanical, Electrical, Instrumentation, or another relevant engineering disciplin Experience
• Approximately 1 To 5 years of relevant experience in engineering documentation, maintenance documentation, or technical services in the pharmaceutical manufacturing industry.
• Experience in a GMP-regulated pharmaceutical manufacturing facility is preferred.
• Freshers may be considered for trainee or junior-level positions, depending on organizational requirements.

5. Required Skills and Competencies

• Good knowledge of cGMP and pharmaceutical documentation practices.
• Familiarity with engineering SOPs, preventive maintenance, equipment records, and utility documentation.
• Basic understanding of change control, deviation, CAPA, calibration, qualification, and validation documentation.
• Knowledge of document control, revision management, archival, and record retrieval.
• Proficiency in MS Excel, MS Word, and other standard documentation tools.
• Good written communication, coordination, and record-management skills.
• Strong attention to detail, accuracy, and data integrity.
• Ability to prioritize documentation activities and meet defined timelines.

Interested Candidate Send Resume

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