About the Job
About
Aligned Automation
At
Aligned Automation, we live by our "Better
Together" philosophy to build a better world. As a strategic service
provider to Fortune 500 companies, we help digitize enterprise operations and
drive impactful business strategies. Our purpose goes beyond projects—we strive
to deliver meaningful, sustainable change that shapes a more optimistic and
equitable future.
Our
culture is deeply rooted in our 4Cs—Care, Courage, Curiosity,
and Collaboration—ensuring that each employee is empowered to grow,
innovate, and thrive in an inclusive workplace.
Location: Indore
Job Type: Full-time
About the Role:
We are seeking an experienced CSV Engineer to
drive the validation and compliance strategy for computerized systems across
the pharmaceutical manufacturing area. This role will be responsible for
ensuring all GxP-regulated systems are validated, tested, and maintained in
compliance with industry regulations including 21 CFR Part 11, EU Annex 11, and
GAMP 5 guidelines.
This role combines leadership in CSV practices with
hands-on Quality Assurance testing oversight, working closely with
cross-functional teams across IT, Quality, Manufacturing, and Engineering.
Key Responsibilities:
Validation Leadership & QA Testing
- Review
and approve SDLC deliverables and validation documentation for
GxP-regulated computerized systems.
- Oversee
the development and execution of validation test plans and test scripts
for system implementations and changes.
- Provide
Quality Assurance leadership in testing activities, including defect
tracking, resolution, retesting, and ensuring complete traceability.
- Review
and approve compliance plans, user requirements, traceability matrices,
and validation summary reports.
- Ensure
proper documentation and rigorous testing practices are followed to meet
audit and inspection readiness standards.
Compliance & Risk Management
- Maintain
current knowledge of applicable regulations (21 CFR Part 11, GAMP, ALCOA+,
Data Integrity).
- Ensure
validation efforts align with quality and compliance standards to minimize
regulatory risk.
- Participate
in audits and inspections; review and approve CAPA plans related to audit
findings.
- Own,
maintain, and revise CSV-related SOPs, policies, and work instructions.
Team & Project Leadership
- Lead
and mentor a team of CSV and QA professionals across various validation
projects and system life-cycles.
- Provide
strategic CSV support for process improvements, site projects, and system
upgrades.
- Collaborate
with senior stakeholders to ensure business needs align with validation
and compliance expectations.
Stakeholder & Cross-Functional
Engagement
- Work
closely with project managers, system owners, IT, and QA teams to deliver
compliant and efficient systems.
- Serve
as the subject matter expert for validation throughout the SDLC and
post-implementation phases.
Qualifications:
- Bachelor’s
degree in Computer Science, Engineering, Life Sciences, or related field
(or equivalent experience).
- Minimum
5 years of experience in Computer Systems
Validation (CSV) or QA Testing in a regulated pharmaceutical or
biotech environment.
- Strong
knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP
5, and Data Integrity principles.
- Demonstrated
expertise in QA testing, including test case creation, test
execution, and defect resolution.
- Experience
validating GxP-related systems.
- Experience
leading validation and QA testing teams.
- Excellent
analytical, documentation, and communication skills.
Preferred Qualifications:
- Exposure
to cloud/SaaS-based GxP system validation.
- Certifications
such as PMP, ASQ, or GxP/CSV-related credentials.
Key Competencies:
- Risk-Based
Thinking
- Attention
to Detail
- Leadership
and Coaching
- Quality
and Regulatory Focus
- Stakeholder
Management
- Problem
Solving and Decision Making
Skills Required
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience)
- Minimum 5 years experience in Computer Systems Validation (CSV) or QA Testing in regulated pharmaceutical or biotech environment
- Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity principles
- Demonstrated expertise in QA testing including test case creation, execution, and defect resolution
- Experience validating GxP-related systems and ensuring traceability and audit readiness
- Experience leading and mentoring validation and QA testing teams
- Excellent analytical, documentation, and communication skills
- Exposure to cloud/SaaS-based GxP system validation
- Certifications such as PMP, ASQ, or GxP/CSV-related credentials
What We Do
Technology, society, economy, policy – all moving at breakneck speed in our 21st century world. You’re feeling the pressure to quickly implement new business models, find new value, make split-second informed decisions and keep one step ahead of customers. How? The answer lies in the ability to make quick, accurate and sustainable business decisions. We believe digital offers a way of doing things better – but the journey to transformation doesn’t have to be painful. At Aligned Automation, we work hard to digitally enable your business strategy – connecting processes, technologies and people to unlock value and drive critical business outcomes.
