Analytical and Laboratory Instrumentation Engineer

The Senior Analytical and Laboratory Instrumentation Engineer is responsible for leading and executing complex service operations, compliance-driven validations, and technical mentorship across client sites. This role demands in-depth expertise in analytical instruments such as HPLC, GC, FTIR, UV-Vis, TOC, and CDS software, and the ability to work under regulatory frameworks (21 CFR Part 11, GMP, GLP, ISO 17025). The position also involves interfacing with cross-functional teams, managing customer relationships, and guiding junior engineers.

Key Responsibilities:

• Lead and execute installation, commissioning, and qualification (IQ/OQ/PQ) of high-end analytical instruments.

• Perform advanced diagnostics, calibration, and root cause analysis on equipment failures.

• Design and review validation protocols, ensuring compliance with pharma and laboratory standards.

• Manage preventive and breakdown maintenance schedules, spare parts planning, and AMC execution.

• Serve as a technical escalation point for complex troubleshooting and compliance gaps.

• Interface with OEMs, QA/QC teams, IT departments, and regulatory auditors as needed.

• Drive technical training sessions for clients and internal teams on instrumentation, software, and documentation practices.

• Ensure documentation of service reports, deviation logs, compliance summaries, and digital records in audit-ready formats.

• Collaborate with sales/application engineers for technical support during client discussions or pilot trials.

Key Focus Areas:

1. Expertise in Analytical Instrumentation

   • Proficient in systems like:

     • HPLC / UPLC / GC / GC-MS

     • UV-Vis / FTIR / TOC / Titrators / Balances

     • Karl Fischer, Dissolution, and LIMS-integrated systems

   • Ability to interpret chromatograms, instrument logs, detector performance, and pump curves.

2. Regulatory Compliance & Documentation

   • In-depth knowledge of GMP, GLP, 21 CFR Part 11, and data integrity (ALCOA+) principles.

   • Author and review validation protocols (IQ/OQ/PQ/SAT) and compliance checklists.

3. Advanced Troubleshooting & Technical Support

   • Handle complex hardware/software issues, connectivity problems, and instrument drift/root cause analysis.

   • Escalate and coordinate with OEMs when required.

4. Software & Digital Systems

   • Expertise in CDS platforms: Empower, Chromeleon, LabSolutions, OpenLab CDS.

   • Support integration with LIMS, SCADA, or digital lab platforms.

5. Customer Relationship & Project Handling

   • Manage key accounts, ensure timely delivery of service SLAs, and resolve escalations.

   • Conduct technical presentations, audits, and CAPA closures.

6. Mentorship & Team Leadership

   • Train junior and mid-level engineers on technical processes, service quality, and field safety.

   • Support recruitment, onboarding, and performance review inputs for the service team.

7. Safety, Quality & Asset Management

   • Enforce EHS compliance, calibration traceability, and proper use of tools and reference standards.

   • Maintain NABL traceable calibration kits, test standards, and service documentation archives.

Qualifications & Requirements:

• Education:

  • B.E. / B.Tech / M.Tech in Instrumentation, Electronics, Mechatronics, Biomedical, or Chemical Engineering

  • OR M.Sc. / B.Sc. in Analytical Chemistry / Instrumentation / Life Sciences

• Experience:

  • Minimum 6–10 years of relevant experience in analytical instrumentation, validation, and lab compliance.

• Technical Competence:

  • Strong command over hardware diagnostics, software integration, SOP writing, and regulatory protocols.

• Soft Skills:

  • Client-facing maturity, project coordination, training delivery, and audit preparedness.

• Travel:

  • Willingness to travel extensively across client labs, plants, or multi-city locations.