Engelburg controls
Website:
engelburgcontrols.com
Job details:
Position Validation Engineer – Female Candidate Only
Location Bangalore
Employment Type
Full-Time
Experience
1–2 years in Validation / Automation / Pharmaceutical / Life Sciences industry preferred.
Job Summary
We are looking for a Validation Engineer to support validation activities for automation and process control systems in pharmaceutical and industrial projects.
Basic of PLC , HMI and SCADA
The candidate will be responsible for preparing validation documentation, executing validation protocols, coordinating testing activities, and ensuring compliance with applicable quality and regulatory requirements.
Key Responsibilities
- Prepare and review validation documents such as:
- URS – User Requirement Specification
- FDS/SDS
- Risk Assessment
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- FAT/SAT protocols and reports
- Traceability Matrix
- Validation Summary Reports
- Execute and document IQ/OQ/PQ activities at customer sites.
- Support PLC, HMI, SCADA and automation system validation.
- Verify system functionality against approved specifications and test cases.
- Coordinate with PLC/SCADA engineers, QA/QC teams and customers during validation activities.
- Review automation software and system documentation from a validation perspective.
- Identify deviations, prepare deviation reports and support CAPA activities.
- Maintain validation records and ensure proper document control.
- Participate in FAT, SAT and commissioning activities.
- Support CSV (Computer System Validation) activities where required.
- Ensure validation activities comply with applicable GMP, GAMP 5, 21 CFR Part 11 and customer requirements.
- Prepare validation reports and maintain project documentation.
- Travel to customer sites for FAT/SAT/validation activities when required.
Required Skills
- Good knowledge of IQ/OQ/PQ and validation lifecycle.
- Understanding of GMP and GAMP 5 principles.
- Basic knowledge of 21 CFR Part 11 and data integrity.
- Good documentation and report-writing skills.
- Basic understanding of PLC, HMI and SCADA systems.
- Ability to read electrical/control system drawings is an advantage.
- Good communication and coordination skills.
- Proficiency in MS Word, Excel and documentation tools.
- Ability to work independently and as part of a project team.
Educational Qualification
B.E./B.Tech/Diploma in:
- Instrumentation & Control
- Electronics & Instrumentation
- Electrical & Electronics
- Electronics & Communication
- Automation-PLC
Candidates with a Pharmaceutical/Life Sciences validation background will be preferred.
Candidate Profile
- Female candidates are preferred for this position.
- Good communication and interpersonal skills.
- Willingness to travel to customer/project sites.
- Strong attention to detail and documentation discipline.
- Ability to coordinate with multiple departments and customers.
- Freshers with relevant internship/project experience may also be considered.
Click on Apply to know more.