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25 Plant Engineer Jobs

Plant Engineer L2

3-8 years

Bangalore / Bengaluru

4 vacancies

Plant Engineer L2

Fidelis Technology Services

posted 19hr ago

Job Role Insights

Flexible timing

Key skills for the job

Job Description

Product Validation ~Documentation Control ~Equipment Validation & Qualification ~Product Lifecycle Management ~Defect Management ~Project Handling ➢ Expertise Knowledge of FDA regulations, EU guidelines, CSV, GAMP guidelines and product development process. ➢ Ensuring the quality compliance with respective areas and GxP guidelines. ➢ Significant exposure in maintaining & ensuring stringent adherence to quality, identifying gaps, norms & practices. ➢ Abilities to understand their requirement related to product they need and deliverables. ➢ Abilities in implementing quality plans with focus on identifying gaps.


Key result Areas: ➢ Execution and compliation of CSV Qualifications for all the GxP applications in Manufacturing area. ➢ Execution of Qualification activities IQ, OQ, PQ for all GxP systems in the manufacturing process equipments. ➢ Administration and User Management of all the laboratory applications, Instruments, Manufacturing process Equipments as per SOP. ➢ Vendor co-ordination for all the IT related news projects and requirements. ➢ Co-ordination with CFT's for qualification document approvals. ➢ Performing the User ID Role Matrix, Manual Backup periodic activity as per SOP. ➢ Ensuring that validation activities align with relevant regulations such as FDA 21 CFR Part 11, EU Annex 11, and other applicable guidelines. ➢ Ensuring all documentation aligns with regulatory expectations and internal quality standards. ➢ Responsible for curation and review of quality and validation documents with assurance of GxP compliance, adherence to safety polices. ➢ Responsible for knowledge sharing to new joiners on projects and standard operating procedure. ➢ Responsible for putting ideas and suggestions to teams with respect to process & projects.



Employment Type: Full Time, Permanent

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What Plant Engineer at Fidelis Technology Services are saying

Plant Engineer salary at Fidelis Technology Services

reported by 1 employee with 3 years exp.
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₹4 L/yr - ₹5.2 L/yr
27% less than the average Plant Engineer Salary in India
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What Fidelis Technology Services employees are saying about work life

based on 238 employees
61%
48%
64%
94%
Flexible timing
Monday to Friday
No travel
Day Shift
View more insights

Fidelis Technology Services Benefits

Submitted by Company
Health Insurance
Job Training
International Relocation
Soft Skill Training
Submitted by Employees
Job Training
Work From Home
Health Insurance
Soft Skill Training
Cafeteria
Free Food +6 more
View more benefits

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