Validation Engineer
Bengaluru, Karnataka, India
Full Time
Mid Level
About Us
Headquartered in Princeton, New Jersey, USA, with offices in Canada, India, and Germany, we are a leading publicly traded global SaaS company that helps enterprise life sciences organizations accelerate new drug development into approved medicines that save lives and keep employees safe. Through our intelligently designed low-code software platforms, we digitize drug research and development, laboratory testing, regulatory approvals, and pharmaceutical manufacturing on a single, unified cloud platform that is cost-effective, ready to deploy, and easy to use. Highly regulated companies choose Xybion to help them become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Since our founding in 1977, we have supported through software, services, and consulting, 100% of the top 20 global life sciences companies. Serving more than 160 customers in 25 countries, we have the global scale and expertise to bring our employees around the world together to drive innovation, manage complex business processes, improve program administration and client service delivery.
Validation Engineer (4 to 6 years’ experience in IT life science/ pharmaceutical industry)
Xybion is seeking a Validation Engineer for our client computer validation/ qualification projects
Location: Bangalore
Key Responsibilities:
Education:
Minimum of Bachelor’s degree in a life science or technology field (work experience will be considered in lieu of required degree).
Compensation:
We offer highly competitive compensation, including base salary, sales commission, performance-linked bonus, along with a comprehensive benefits package.
We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/
Xybion is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, colour, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Headquartered in Princeton, New Jersey, USA, with offices in Canada, India, and Germany, we are a leading publicly traded global SaaS company that helps enterprise life sciences organizations accelerate new drug development into approved medicines that save lives and keep employees safe. Through our intelligently designed low-code software platforms, we digitize drug research and development, laboratory testing, regulatory approvals, and pharmaceutical manufacturing on a single, unified cloud platform that is cost-effective, ready to deploy, and easy to use. Highly regulated companies choose Xybion to help them become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Since our founding in 1977, we have supported through software, services, and consulting, 100% of the top 20 global life sciences companies. Serving more than 160 customers in 25 countries, we have the global scale and expertise to bring our employees around the world together to drive innovation, manage complex business processes, improve program administration and client service delivery.
Validation Engineer (4 to 6 years’ experience in IT life science/ pharmaceutical industry)
Xybion is seeking a Validation Engineer for our client computer validation/ qualification projects
Location: Bangalore
Key Responsibilities:
- Responsible for validation/ qualification activities in relation to computer systems, instrument, equipment, facilities, utilities, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
- Create Validation scripts / protocols against requirements/ specifications
- Execute validation scripts / qualification activities and log & track exceptions
- Responsible for qualification data collection and analysis against acceptance criteria
- Provide documentation updates (SOPs, Forms, etc.)
- 4 to 6 years of Computer System Validation & Equipment Qualification experience in pharmaceutical, biotechnology a must
- Should have relevant experience in creating and executing OQ, PQ, SAT, FAT scripts in manufacturing, laboratory equipment, clean process utilities
- Experience in the execution of commissioning and qualification of process control systems
- GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements, among others
- Excellent communication skills
- Strong attention to detail
Education:
Minimum of Bachelor’s degree in a life science or technology field (work experience will be considered in lieu of required degree).
Compensation:
We offer highly competitive compensation, including base salary, sales commission, performance-linked bonus, along with a comprehensive benefits package.
We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/
Xybion is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, colour, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
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