Job Description
– QA Documentation Engineer Company: Esteril Process Solutions Department: Quality Assurance / Validation

Experience:
Minimum 2 Years Qualification: B.
E./B.
Tech in Chemical Engineering or Mechanical Engineering, or B.
Sc. in a relevant discipline Job Summary Estriel Process Solutions is looking for a skilled QA Documentation Engineer with experience in preparing, reviewing, and executing technical quality and validation documentation for process equipment and systems. The candidate must be capable of independently developing Functional Design Specifications (FDS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Factory Acceptance Test (FAT) documents in accordance with customer requirements, engineering specifications, and applicable quality standards.

Key Responsibilities
* Independently develop, review, and maintain FDS, DQ, IQ, OQ, and FAT documents.
* Prepare technical documentation based on user requirements, process descriptions, equipment specifications, and engineering drawings.
* Develop validation protocols, test procedures, acceptance criteria, and test result documentation.
* Prepare equipment qualification documents, including design verification, installation checks, operational testing, and functional verification, as applicable.
* Develop FAT protocols and reports, including functional checks, safety interlocks, alarm verification, and equipment performance tests, as applicable.
* Coordinate with engineering, automation, production, QA/QC, and project teams to collect technical inputs and finalize documentation.
* Review technical drawings, P&IDs;, equipment specifications, and control system descriptions for documentation purposes.
* Ensure traceability between customer requirements, design specifications, test cases, and acceptance criteria.
* Prepare and maintain SOPs,



inspection reports, test reports, document registers, and revision history.
* Coordinate document reviews and approvals with internal teams and customers.
* Support FAT activities, customer inspections, documentation reviews, and audits.
* Ensure documentation complies with applicable standards, project specifications, and customer requirements. Required Qualifications and Skills
* Minimum 2 years of relevant experience in QA documentation, equipment qualification, validation documentation, or technical documentation.
* B.
E./B.
Tech in Chemical Engineering or Mechanical Engineering, or B.
Sc. in a relevant discipline.
* Practical experience in independently preparing FDS, DQ, IQ, OQ, and FAT documents.
* Ability to understand engineering drawings, P&IDs;, equipment specifications, and process requirements.
* Knowledge of qualification protocols, test procedures, acceptance criteria, and traceability matrices.
* Positive proficiency in MS Word, Excel, and technical report preparation.
* Strong written communication, analytical skills, and attention to detail. Preferred Experience
* Experience in process equipment, industrial automation, skid-mounted systems, or process solutions.
* Familiarity with GMP,risk assessment, where applicable to the project.
* Experience coordinating with engineering teams and customers for document review, approval, and FAT execution.
* Knowledge of PLC/SCADA documentation and functional testing, where applicable. Ideal Candidate The ideal candidate should be capable of independently preparing high-quality technical and qualification documents from project requirements, coordinating with cross-functional teams, and ensuring documentation readiness for customer review, FAT, and equipment qualification activities. Candidates with hands-on experience in developing FDS, DQ, IQ, OQ, and FAT documentation are encouraged to apply.

📌 QA-Documentation Engineer (Mumbai)
🏢 Esteril Process Solutions
📍 Mumbai