DL
IOT_Manufacturing Systems Test Engineer
Diverse Lynx India
🇮🇳 India
On-site
4 months ago
- GMP
- Excel
- PowerPoint
- Visio
- GxP
- Change Management
- Technical Writing
4 months ago
Overall Objectives of the Position
The "Manufacturing Systems Test Engineer” plays a crucial role in ensuring the quality and efficiency of manufacturing processes through Electronic Batch Records (MES/EBR) and Data Historian (DH) systems.
- Collaborate with the IT team, system owners, vendors, and business stakeholders to coordinate Specifications (URS).
- Author or co-author specifications (Functional Specifications (FS), Design Specifications (DS), Configuration Specifications (CS), and Technical Specifications (TS) for EBR and DH systems.
- Author or co-author including Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT) protocol/scripts to ensure systems meet specified requirements and specifications.
- On demand, perform or support OQ testing as per approved protocols. Support business in the execution of PQ and UAT.
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Responsibilities
Computerized System Validation (CSV)
- Design, configure, and release Master Batch Records (MBRs) and workflows for MES and Data Historian systems, demonstrating expertise in these areas.
- Utilize in-depth knowledge to configure equipment using Aveva PI Data Historian.
- Effectively collaborate in a global environment and with international teams.
- Conduct validation testing activities for DH and Manufacturing Equipment System (Client-X MES) per FDA regulations, GAMP guidelines, and Client's internal validation procedures.
- Develop and execute test protocols (OQ and PQ) for DH and MES systems, ensuring comprehensive coverage of functional and performance requirements.
- Perform risk assessments and impact analyses to identify potential validation issues and establish robust testing strategies.
- Collaborate closely with cross-functional teams (IT, Quality Assurance, Manufacturing, Validation and Engineering) to coordinate validation activities and address issues.
- Document all the test results, deviations, and corrective actions per GMP documentation practices.
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Documentation & Quality Oversight
- Serve as a local engineer to author, reviewer and approve for validation documentation and change records.
- Review SOPs, validation, and system lifecycle documentation.
- Support deviation investigation, CAPAs, and change controls related to computerized systems.
- Maintain validation traceability and ensure data integrity principles (ALCOA+) are met
- Demonstrate excellent communication skills for effective interaction with internal and external stakeholders in a multicultural environment.
- Strong working knowledge of Microsoft Office tools, including Excel, PowerPoint, and Visio.
System Lifecycle & Operations Support
- Support system implementation, upgrades, patches, and decommissioning activities.
- Assess validation of impact for system changes and IT/OT integrations.
- Participate in audits and inspections (internal and regulatory) and support audit responses.
- Manage a high workload while consistently delivering high-quality work on schedule.
- Foster collaboration as a team player, sharing knowledge and addressing challenges collectively.
- Familiarity with current manufacturing models and concepts in Life Sciences and Healthcare, with a proven track record in Pharmaceutical GxP project implementation and validation.
- Knowledge of Computer Systems Validation, SDLC methodologies, 21CFR Part 11, cGMP, including GAMP and EU Annex 11.
- Experience with new implementation and upgrade projects from requirement gathering through final MES delivery
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Required Qualification
• Bachelor's degree in engineering, Computer Science, Information Systems, or related technical field.
• 3+ years of experience in Computer System Validation within a GxP-regulated environment.
• Hands-on experience validating digital manufacturing systems such as MES, data historians, or integrated IT/OT platforms.
• Strong knowledge of regulatory expectations: GAMP5, 21 CFR Part 11, EMA Annex 11, Data Integrity principles (ALCOA+).
• Experience authoring and executing IQ/OQ/PQ protocols and validation reports.
• Familiarity with change management, deviation handling, and risk-based validation approaches.
Preferred Qualification
- Experience in pharmaceutical, biotech, or medical device manufacturing environments.
- Experience with Client-X system and ALM (HPALM) tool.
- Prior experience acting as a document authoring using digital tools and approver.
- Knowledge of cloud or hybrid systems in regulated environments (good to have).
Key Skills & Competencies
- Strong technical writing and documentation skills
- Detail-oriented with a compliance mindset
- Ability to work cross-functionally with IT, Automation, Quality, and Operations
- Comfortable balancing compliance with practical, risk-based solutions
- Clear communication and stakeholder management skills
IOT_Manufacturing Systems Test Engineer · Diverse Lynx India