Senior Associate – Instrumentation Engineer
Location: Bangalore, Karnataka, India
Company: Apotex Research Pvt. Ltd.
Employment Type: Full-Time
Role Summary
The Senior Associate – Instrumentation Engineer is responsible for the installation, calibration, qualification, maintenance, and troubleshooting of analytical and laboratory instrumentation used across Research & Development, Bioanalytical, and Quality Control laboratories. The role ensures all instrumentation activities are performed in compliance with GMP, GLP, GCP, and global regulatory requirements while maintaining laboratory readiness and data integrity.
This position requires strong technical expertise in analytical instruments, software validation, equipment qualification, calibration management, and regulatory compliance within a pharmaceutical research environment.
Key Responsibilities
Instrumentation Maintenance & Calibration
Perform preventive and corrective maintenance of laboratory instruments.
Execute calibration activities for:
HPLC Systems
GC Systems
LC-MS/MS Instruments
Analytical Balances
Pipettes
Laboratory Monitoring Equipment
Ensure instruments remain in optimal working condition.
Troubleshoot and resolve instrumentation issues to minimize downtime.
Maintain calibration schedules and compliance requirements.
Instrument Installation & Qualification
Support installation and commissioning of laboratory instruments.
Coordinate and monitor:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Ensure qualification activities are completed according to approved protocols.
Maintain qualification documentation and records.
Support periodic requalification activities.
Software Validation & Compliance
Assist in preparation and execution of:
Software Validation Protocols
Validation Reports
Data Integrity Assessments
Ensure compliance with:
21 CFR Part 11
GMP Requirements
Data Integrity Guidelines
Support computerized system validation (CSV) activities.
Maintain software validation documentation and audit trails.
Documentation & Record Management
Prepare, review, and revise:
Instrument SOPs
Calibration Procedures
Qualification Documents
Validation Reports
Maintain:
Instrument Qualification Files
Calibration Records
Maintenance Logs
Validation Documentation
Ensure records are accurate, complete, and audit-ready.
Coordinate archival of laboratory documentation.
Vendor & Service Management
Coordinate with external service providers and vendor engineers for:
Maintenance Activities
Calibration Services
Equipment Repairs
Qualification Support
Manage Annual Maintenance Contracts (AMCs).
Monitor vendor performance and service quality.
Ensure timely execution of service activities.
Laboratory Monitoring Systems Support
Monitor:
Freezer Monitoring Systems
Environmental Monitoring Systems
Alarm Management Systems
Respond promptly to system alarms and deviations.
Escalate critical equipment issues to management when required.
Ensure continuous monitoring compliance and documentation.
Troubleshooting & Technical Support
Investigate and resolve:
Analytical Instrument Issues
Equipment Failures
Calibration Deviations
Operational Problems
Provide technical support to laboratory users.
Recommend corrective and preventive actions when required.
Support root cause investigations and equipment reliability initiatives.
Regulatory Compliance & Quality Management
Ensure all activities comply with:
Good Manufacturing Practices (GMP)
Good Laboratory Practices (GLP)
Good Clinical Practices (GCP)
Good Automated Laboratory Practices (GALP)
USFDA Guidelines
DCGI/CDSCO Regulations
TGA Requirements
ICH Guidelines
EMA Expectations
Maintain inspection and audit readiness.
Support internal audits and regulatory inspections.
Continuous Improvement & Operational Excellence
Identify opportunities to improve equipment reliability and laboratory efficiency.
Participate in process improvement initiatives.
Support implementation of best practices for instrumentation management.
Contribute to operational excellence and compliance programs.
Health, Safety & Environmental Compliance
Follow all safety procedures and safe work practices.
Ensure safe handling and operation of laboratory equipment.
Support environmental health and safety initiatives.
Adhere to company quality, ethics, safety, and compliance policies.
Required Qualifications
Education
One of the following qualifications:
Bachelor of Engineering (B.E.) in Instrumentation Engineering
Bachelor of Technology (B.Tech.) in Instrumentation Engineering
Master of Science (M.Sc.) in Instrumentation
Related Engineering Discipline
Experience
2–4 years of experience in:
Analytical Research & Development (AR&D)
Bioanalytical Laboratories
Quality Control Laboratories
Pharmaceutical Research Environments
Experience supporting laboratory instrumentation and qualification programs.
Hands-on experience in regulated pharmaceutical environments.
Uttar Pradesh :
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