Full Stack Engineer
Project Role Description : Responsible for developing and/or engineering the end-to-end features of a system, from user experience to backend code. Use development skills to deliver innovative solutions that help our clients improve the services they provide. Leverage new technologies that can be applied to solve challenging business problems with a cloud first and agile mindset.
Must have skills : Computer System Validation (CSV)
Good to have skills : NA
Minimum 5 year(s) of experience is required
Educational Qualification : 15 years full time education
Summary:
A leadership-oriented Computerized System Validation (CSV) and Computer Software Assurance (CSA) professional responsible for guiding small teams through end-to-end validation activities in a GxP-regulated environment. This role involves acting as the face of the compliance team, developing Standard Operating Procedures (SOPs), ensuring adherence to global regulatory standards (including FDA, EMEA, 21 CFR Part 11, and GAMP5), and actively supporting external regulatory audits.
Roles & Responsibilities:
- Team Leadership & Execution: Guide and manage small teams while actively performing and overseeing project validation activities.
- Representation & Reporting: Act as the primary liaison for the compliance/validation team during internal meetings, taking charge of gathering data and reporting compliance metrics to management.
- Team Mentorship: Coach and mentor team members to guarantee complete understanding and consistent execution of client workflows and project validation targets.
- Regulatory Oversight: Maintain a comprehensive and up-to-date understanding of FDA and other global regulatory guidelines.
Professional & Technical Skills:
- Global Regulatory Knowledge: Deep expertise in Pharmaceutical Regulatory Compliance and CSV/CSA across major regulatory bodies (e.g., FDA, EMEA).
- End-to-End Validation: Comprehensive knowledge of full-cycle CSV within GxP environments, featuring extensive hands-on experience with the V-Model and the complete validation lifecycle for regulated projects.
- Industry Frameworks: Strong grasp of pharmaceutical regulatory mandates, specifically focusing on 21 CFR Part 11 and GAMP5 guidelines.
- Technical Writing: Proven ability to author, develop, and refine Standard Operating Procedures (SOPs) and Work Instructions.
- Documentation Standards: High level of GxP awareness, including strict adherence to Good Documentation Practices (GDP).
- Audit Support: Practical experience preparing for, participating in, and supporting external regulatory audits.
- Communication & Analysis: Exceptional analytical capabilities paired with strong, clear communication skills.
- Leadership & Critical Thinking: Demonstrated leadership qualities combined with effective problem-solving and troubleshooting abilities.
- Ability to collaborate with diverse teams and stakeholders to gather and validate requirements.
- Excellent problem-solving skills to address challenges during process design and implementation.
- Familiarity with regulatory and compliance considerations related to system validation.
Additional Information:
- Degree: Bachelor of Engineering (BE) degree or an equivalent academic credential.
- The candidate should have minimum 7 years of experience
- This position is based at our Bangalore office.
- A 15 years full time education is required.
Bengaluru
Requesting an Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at 1 (877) 889-9009 or send us an email or speak with your recruiter.
Equal Employment Opportunity Statement
We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
For details, view a copy of the Accenture Equal Opportunity Statement
Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities.
Accenture is committed to providing veteran employment opportunities to our service men and women.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information.
Please read Accenture’s Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
We work with one shared purpose: to deliver on the promise of technology and human ingenuity. Every day, more than 775,000 of us help our stakeholders continuously reinvent. Together, we drive positive change and deliver value to our clients, partners, shareholders, communities, and each other.
We believe that delivering value requires innovation, and innovation thrives in an inclusive and diverse environment. We actively foster a workplace free from bias, where everyone feels a sense of belonging and is respected and empowered to do their best work.
At Accenture, we see well-being holistically, supporting our people’s physical, mental, and financial health. We also provide opportunities to keep skills relevant through certifications, learning, and diverse work experiences. We’re proud to be consistently recognized as one of the World’s Best Workplaces™.
Join Accenture to work at the heart of change. Visit us at www.accenture.com.