Job Description

We are looking for a Senior Development Operations Engineer to join our team in Bangalore. This is an amazing opportunity to work on products focused on Drug Safety reporting to a Senior Manager. We would love to speak with you if you have skills in software compliance within a GxP environment or equivalent regulated industry.

About You - experience, education, skills, and accomplishments

Bachelors' degree or higher in Computer Engineering or Computer Science, plus 5 or more years' software development experience, or an equivalent combination of education and experience. Strong interpersonal and communication skills, both verbal and written in the English language. Strong organizational and leadership skills. Strong problem-solving skills. Possess high-level ethics and integrity. Goal oriented. The ability to interact communicate effectively with colleagues from all levels of the organization. Must be highly motivated and able influence and motivate others. Understanding and ability to apply several programming/scripting languages. Ability to work with software configuration management systems. Working knowledge of cloud hosting providers such as AWS. Working knowledge of Continuous Integration and Continuous Deployment methodologies with GitHub or similar. Working knowledge of IaC such as Terraform. Experience with creation and maintenance of official documentation. Proven ability to work with and direct teams to accomplish goals.

It would be great if you also had

Experience in Computer Systems Validation (CSV) or Model Validation and IT System Controls within a regulated industry.

What will you be doing in this role?

Interacting with the Software Development and Regulatory Compliance organisations on a day-to-day basis by gathering information and organising initiatives to optimise and streamline Computer Systems Validation activities. Supporting the development teams by creating automations, tools, pipelines, processes and leveraging modern technologies such as AI Models/Agents to aid in the development and delivery of Validated Software. Working directly with members of Development, Regulatory Compliance Management and other internal teams to ensure the accuracy and consistency of system software development validation deliverables, as well as to proactively communicate status of validation undertakings, including communication of any identified barriers to management. Fostering and supporting Computer Systems Validation knowledge both for supporting development teams as well as the wider Clarivate audience. Utilizing knowledge in identification and management of risks pertinent to computer systems validation practices within a regulated landscape and communication of these risks to others. Proactively monitoring systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices Facilitating the identification and development of Standard Operating Procedures ("SOP") by: Assisting with the writing, revising, and reviewing of SOPs and Work Instructions, as assigned Utilizing AI to assist in the drafting of documentation. Assisting with the development and enhancement of quality/compliance processes to promote, facilitate and ensure compliance with all regulatory and company standards. Supporting internal and external audit activities (including, but not necessarily limited to customer and Health Authority regulatory audits).

Product you will be developing

The role involves supporting multiple product teams predominantly in the Pharmacovigilance (Drug Safety) space.

About the Team

You will be part of the Engineering Compliance function embedded within several development teams. The Engineering Compliance function works directly with stakeholders to optimize and streamline the compliance processes during the software development lifecycle.

Hours of Work

45 working hours Currently Hybrid working model

At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.