Engineering Documentation Specialist

Job Title: Engineering Documentation Specialist – Sterile Injectable Facility (Remote – India)

Department: Engineering / Technical Operations

Reports To: Associate Director of Engineering / Director of Engineering (U.S.)

Location: Remote (India) – Supporting U.S.-based pharmaceutical injectable manufacturing facilities

Position Overview:

The Engineering Documentation Specialist will be responsible for creating, maintaining, and

managing all engineering-related documentation for sterile injectable manufacturing facilities

operating under FDA 503B or cGMP environments. This position plays a critical role in ensuring

technical accuracy, regulatory compliance, and timely documentation of engineering activities,

investigations, and quality actions.

The ideal candidate will have a solid understanding of pharmaceutical engineering systems,

equipment qualification, utilities, and regulatory documentation practices.

Key Responsibilities:

1. Documentation & SOP Management

• Draft, revise, and maintain Standard Operating Procedures (SOPs) related to

engineering, maintenance, calibration, and utilities.

• Ensure all documentation meets FDA, cGMP, and company quality standards.

• Manage document change requests, track approvals, and ensure controlled document

distribution.

2. Engineering Event Documentation

• Prepare breakdown preliminary investigation reports, work carried out summaries,

and detailed root cause analyses (RCA).

• Utilize 5-Why, Fishbone, and Pareto tools for structured problem-solving and

investigation.

• Coordinate with U.S.-based engineering staff for accurate technical inputs and

documentation updates.

3. Deviation & Change Management

• Draft and document engineering-related deviations, perform investigation summaries,

and recommend corrective and preventive actions.

• Initiate and draft Change Controls, including justification, impact assessment, risk

analysis, and implementation documentation.

• Conduct risk assessments (FMEA/RA templates) and ensure alignment with Quality

Management System (QMS) expectations.

4. Project Documentation Support

• Prepare User Requirement Specifications (URS), Design Qualification (DQ),

Installation Qualification (IQ), Operation Qualification (OQ) and related technical

documents for new equipment, systems, or modifications.

• Coordinate with vendors and internal stakeholders for technical data collection and

documentation consistency.

5. Quality & Compliance Tracking

• Maintain and update CAPA trackers, ensuring timely follow-up and closure of all

engineering-related actions.

• Track and monitor QMC (Quality Management Committee) action items; ensure all

commitments are addressed and closed before deadlines.

• Support in internal and external audit documentation readiness.

6. Reporting & Presentation Support

• Prepare and update Engineering MIS (Management Information

System) presentations and dashboards for monthly reporting.

• Prepare QMR (Quality Management Review) engineering sections, including

performance metrics, deviation trends, and CAPA status.

• Support management in compiling data for KPI tracking, continuous improvement, and

regulatory compliance metrics.

7. Communication & Coordination

• Work closely with U.S.-based Engineering, Quality, and Validation teams via email, calls,

and virtual meetings.

• Follow up with cross-functional teams (Maintenance, Validation, Quality, and Projects) to

gather inputs for timely document completion.

• Ensure consistency and traceability between engineering actions and QMS

documentation.

Qualifications and Experience:

• Bachelor’s Degree in Mechanical, Electrical, Instrumentation, Chemical, or Industrial

Engineering (preferred).

• 3–8 years of experience in engineering documentation or technical writing within

a pharmaceutical / sterile / injectable / 503B environment.

• Solid understanding of GMP, cGMP, 21 CFR Part 210/211, and 503B guidance.

• Experience with deviation, CAPA, and change control systems (TrackWise,

MasterControl, or similar).

• Proficient in root cause analysis tools, risk assessment methodologies (FMEA, 5-Why,

Fishbone), and compliance documentation.

• Strong proficiency in MS Office (Word, Excel, PowerPoint, Outlook).

• Excellent technical writing, analytical, and communication skills.

Key Competencies:

• Strong attention to detail and documentation accuracy.

• Ability to interpret engineering drawings, maintenance logs, and system reports.

• Familiar with HVAC, cleanroom systems, purified water, WFI, nitrogen, and

compressed air utilities.

• Proactive follow-up and task closure discipline.

• Comfortable working independently with remote U.S. engineering leadership.

• Ability to manage multiple documentation tasks under tight timelines.

Preferred Skills:

• Experience in equipment qualification or validation documentation is a plus.

• Exposure to audit and compliance documentation for FDA-regulated environments.

• Experience in MS Power BI or dashboard creation for MIS/QMR reporting.

Work Schedule:

• Flexible remote work hours aligned partially with U.S. time zones (Arizona/PST) for

coordination.