Senior Software Engineer - IT Compliance [T500-10066]

hyderabad

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Position Summary

At BMS, digital innovation and Information Technology are central to our vision of transforming patients’ lives through science. To accelerate our ability to serve patients worldwide, we must unleash the power of technology. We are committed to transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision-making, and enhanced patient care.

The Data Integrity and Computer System Validation (CSV) team, part of BMS’ Global Manufacturing IT organization, is seeking an IT Compliance Engineering to meet evolving and growing needs for IT/Compliance across the company’s manufacturing operations. The successful candidate will apply their compliance/validation skills to validate manufacturing and laboratory systems to support BMS’ worldwide manufacturing operations directly.

If you want a meaningful, exciting, rewarding career, consider joining our diverse team!

Key Responsibilities

Develop and maintain a complete understanding of BMS IT compliance policies and procedures related to all aspects of computer system validation.

Identify and assess potential risks and vulnerabilities in IT systems and processes and develop and implement risk mitigation strategies.

Conduct regular audits and assessments of IT systems, processes, and controls to ensure compliance with applicable regulations and standards.

Participate in regulatory inspections and audits, and support compliance-related activities as needed.

Provide guidance and training to IT staff and other stakeholders on compliance requirements and best practices.

Maintain accurate and up-to-date records and documentation related to IT compliance activities.

Continuously evaluate and improve IT compliance processes and procedures to ensure effectiveness and efficiency by staying current with emerging trends and technologies in IT compliance and providing recommendations for improvement.

Development of Validation strategy, Validation Master Plans related to computer systems validation.

Develop and review Computer System Validation Artifacts, including Validation Master plans, Requirements Specification, Design Specifications, Test Plans (System Test, User Acceptance Test, Installation Qualification), Test Summary Reports (System Test, User Acceptance Test, Installation Qualification), Traceability Matrix, Validation Summary Report, Release for Use Memo, SOP's, Work Instructions.

Ensure that the validation artifacts meet the quality requirements and applicable regulations of FDA, EU, Corporate & International Standards.

Pre-approve and post-approve validation documentation and assessments from a quality perspective.

Provides CSV expertise and guidance related to management, peers, and lower-level professionals.

Participate in the Change Management process, ensuring that all changes to validated computer systems are effectively assessed and that regulatory compliance is always maintained.

Lead the Validation team to ensure all aspects of activity within the group adhere to required policies and procedures, including safety and training.

Lead the Validation team in preparation for regulatory, internal, and corporate audits and inspections.

Represent Validation and BMS for audits and any corporate events (as required).

Report out to senior management on Validation status and metrics. Keep abreast of changing regulatory requirements, standards, and guidelines.

Qualifications & Experience

The IT Compliance Engineer should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline along with 6+ years’ experience in pharmaceutical/ biopharmaceutical manufacturing facilities.

Knowledge of capabilities such as ServiceNow, JIRA, Python, and SQL are beneficial, such as experience configuring JIRA workflows, dashboard, and reports to support visibility and evaluation of process opportunities.

A strong background in focusing on technical solutions.

Growth mindset, enthusiastic about pioneering technology in a regulated industry.

Critical thinking and problem-solving skills, with the ability to troubleshoot and resolve complex challenges, using technology to drive productive change.

Experience with adhering to internal and external requirements, which may include FDA (21CFR, part 11), EMA (Annex 11), GAMP and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9).

Knowledge of Quality principles, computer system development lifecycles, QA methodologies, S88 batch control standards and the and ISA-95 manufacturing plant levels.

Knowledge of Quality principles, computer system development lifecycles, QA methodologies, S88 batch control standards and the and ISA-95 manufacturing plant levels.

Knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines and the technical acumen to work and manage within a regulatory environment.

Relevant experience with data integrity requirements and implementation in a GMP environment.

Knowledge of leading a successful team to project completion.

Problem solving ability and excellent oral and written communications skills.

Experience dealing with regulatory agencies and global audit teams.

Excellent communication skills and ability to influence others.

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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