Job Description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients-- that is what Vantive aspires to deliver.


We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary

Professional experience in areas like Laboratory Management, Equipment Qualifications, Material management. This position may own & perform relevant System activities for a family of Drug Products and Sciences at R&D facility.

Essential Duties and Responsibilities:

As Lab Operator, responsible for equipment qualification (URS, DQ, IQ, OQ, PQ) for Formulation Lab equipment. Responsible for Periodic as well as daily, on-demand calibration and maintenance of formulation Lab equipment. Responsible for Maintaining all the PPE's protective gear, glassware and consumables for formulation activities and routine operations. Responsible for maintaining state of quality compliance in the lab as per global procedures including but not limited to lab procedures, documents, forms, lab data etc. Responsible for setting up the batch startup requirements before execution of scale-up batches in formulation Lab. Responsible for Material Planning & Handling before batch execution in Formulation Lab. Ensure good internal and cross-functional communication and regular status update of activities. Establish, maintain, and update Technical & Design documentation according to Good Documentation Practices. Ensure Quality & Compliance with Vantive policy/Ethics/Data Integrity and Environmental Health and Safety policies.

Qualification:

Diploma in Engineering discipline with minimum 5 years of experience, or Bachelor of Engineering discipline with minimum 3 years of experience or master's in science or Pharmaceutical discipline with minimum experience of 5 years as lab operator in pharmaceutical product development and life cycle management, preferably sterile injectable/parenteral formulations are preferred. Adequate knowledge of Equipment Qualifications and Laboratory management required for effective collaboration with cross-functions and execution of batches on time. Adequate knowledge of Lab Equipment's, Process, and Quality Management Systems. Adequate knowledge of international/regional/national regulations and standards. Demonstrates flexibility and the ability to shift gears between projects comfortably. Excellent oral and written communication skills. Good analytical and problem-solving skill. Good organizational skills. Ability to effectively organize and prioritize tasks.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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