Merck KGaA

Qualification Engineer

Posted On

July 19, 2024

Location

Bangalore, Karnataka

Experience Level

C - Professional (1-3 years)

Job Type

full-time

Apply By

Jan. 28, 2025

Job Description

Job Title: Qualification EngineerJob Location: Peenya, Bangalore Job Decription:Key Responsibilities:Strategize, implement, and maintain Project initiatives that adhere to organizational objectives and Customer’s Project expectations.Manage commissioning and cGMP Qualification of a Bioprocess Equipment.Oversee the perfection of System Qualification protocols (Release Test, Factory Acceptance Test, Installation Qualification and Operational Qualification) for a Bioprocess EquipmentOversee the perfection of Turnover documentation package for a Bioprocess EquipmentAbility to propose Recommended spares requirement for a Bioprocess Equipment for trouble free run.Ability to take-around a Bioprocess equipment with customers during Factory Acceptance TestMaintain overall shopfloor discipline, compliance of organization and customer testing standards.Participate in development of Qualification team, GEMBA meetings, sprints and log progress through completion.Provide independent quality assurance review and approval of validation documents.Strategic Planning for Qualification aiming to complete as per customer promised timelines.Lead and assist with factory and site acceptance (FAT/SAT) testing and IQ/OQ/PQ including documentation review and reporting.Manage the completion of Post FAT tasks in quick Turn Around Time with clear plan.Project coordination and execution for change initiative support by a CAPAPlans CAPEX required for the work center in advance and ensuring that the needs are met in time.Oversee Calibrating and testing equipment and directing this work.Ensure shopfloor safety compliance.Lead the System Qualification Team and Develop them throughout.Perform detailed Root cause Analysis for customer complaints pertaining to Qualification.Ensures that defined KPI’s are met for the area under responsibility.Qualification resources are well managed, Well Balanced according to customer’s changing needs.Document, Delegate and Manage Shop floor assets. BASIC QUALIFICATION:Who are you:Education - Engineering degree in Mechanical / Mechatronics OR Biotechnology or Life Science or Equivalent Experience: 5 – 7 Years experience in Validation of Bioprocess Equipment and worked / Working is Biopharmaceutical companies Technical Skills / Competencies: Good Knowledge in LEANOperational Excellence (Blue or Green Belt Certification)Must be proficient in bioprocess equipment.PMP or equivalent Certified preferredFAT/SAT testing and IQ/OQ/PQ We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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