Life Sciences Computer System Validation Engineer Job at Sopra Steria

Senior Computer System Validation (CSV) Analyst

We are seeking a highly experienced and detail-oriented Senior Computer System V...

Location

India , Hyderabad

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field
12+ years of hands-on experience in Computer System Validation (CSV) in FDA-regulated industries (Pharmaceuticals, Biotechnology, or Medical Devices)
5+ years of extensive expertise in GAMP 5 methodology
Software Development Life Cycle (SDLC)
Risk-based validation approaches
Data integrity principles (ALCOA+)
FDA 21 CFR Part 11 and EU Annex 11
Proven experience leading validation projects and working in global, cross-functional teams

Job Responsibility

Lead the development, review, and approval of Validation Plans, URS, FS, DS, RTM, and Validation Summary Reports
Define and implement risk-based validation strategies aligned with GAMP 5
Establish and standardize validation documentation practices across projects and systems
Ensure all deliverables comply with GxP, FDA, and EU regulatory requirements
Oversee execution of IQ, OQ, PQ protocols, ensuring completeness, accuracy, and compliance
Provide technical leadership during validation activities and troubleshooting
Coordinate with IT, QA, Engineering, and business stakeholders to ensure timely delivery
Review and approve test scripts, execution results, and deviation reports
Act as a subject matter expert (SME) for FDA 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), GAMP 5 framework
Lead risk assessments (FMEA, risk ranking) to define validation scope and effort

Fulltime

Computer System Validation Pharma Senior

Lead computer system validation for automated/computerized systems ensuring GMP ...

Location

Belgium , Wavre

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Master's in Sciences/Biological Engineering (Pharmacist, Bio-Engineer, or equivalent)
7-10 years in computer system validation within pharmaceutical manufacturing
cGMP regulations (GAMP, Eudralex Vol 4 Annex 11, 21 CFR Part 11)
Validation frameworks (ICH, ASTM E2500, lifecycle approach)
SAP and MS Office proficiency
Fluent in both French and English is mandatory
Investigative mindset with strong questioning skills
Ability to influence cross-functional teams
Rigorous, systematic approach to validation
Clear technical writing and stakeholder management

Job Responsibility

Author/review/approve validation plans, summary reports, and periodic review reports
Review design documentation (TCD, ERES, URS, DQ) and qualification protocols/reports (IQ/OQ/PQ)
Manage CSV documentation inventory and review SOPs/templates
Execute qualification/validation per established methodology
manage CAPA, deviations, change control
Represent validation function during internal/external audits
Lead multidisciplinary teams through validation lifecycle

What we offer

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Fulltime

Testing & Computer System Validation Specialist

The Testing & Computer System Validation Specialist role involves ensuring compl...

Location

Canada , Ottawa

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

5–8 years of hands-on experience in Testing and Computer System Validation within the Healthcare / Life Sciences domain
5+ years of strong practical experience with IQ, OQ, and PQ execution
5+ years of in-depth knowledge of CSV methodologies and regulatory standards (FDA, GxP, GAMP 5)
5+ years of experience validating systems such as LIMS, QMS, ERP, EMR, or Clinical systems is a plus
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field

Job Responsibility

Plan, execute, and document Computer System Validation (CSV) activities in compliance with regulatory requirements (GxP, FDA, EMA, etc.)
Develop and review validation deliverables including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, and Validation Summary Reports
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems
Execute manual and automated testing activities aligned with validation requirements
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles (ALCOA+)
Collaborate with cross-functional teams including Quality, IT, Business, and Vendors
Support audits and inspections by preparing validation evidence and responding to audit queries
Participate in change control, deviation management, CAPA, and periodic reviews of validated systems
Provide guidance and mentorship to junior validation/test team members as needed

Computer Systems Validation Engineer

Understand and analyze requirements, define tasks and execute them. Involve in p...

Location

United States , Piscataway, NJ and various unanticipated locations throughout the U.S.

Salary:

Not provided

National Computer Systems

Expiration Date

Until further notice

Requirements

CAPA
CGXP
GAMP
HP ALM
CSV
21 CFR
Audit Trial
Agile
GAP Analysis
Service Now

Job Responsibility

Understand and analyze requirements, define tasks and execute them
Involve in preparing documentation for all aspects of the computer system validation life cycle
Design, deliver, support and maintain GxP computerized systems and security of the associated data
Create and review validation plans, user requirement specifications, functional/design specifications, system integration and user acceptance test design and traceability matrix
Validate models for risk management and compliance
Coordinate with offshore team in an onsite-offshore model

What we offer

Referring employee will be eligible to receive an award of $1,000.00 for the successful referral

Sqa Automation Engineer (Tosca) - Healthcare & Life Sciences - Sdg Project

We are seeking a highly skilled SQA Automation Engineer with strong expertise in...

Location

India , Bangalore

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

8+ years of experience in Software Quality Assurance with strong automation focus
5+ years of hands-on experience with TOSCA (test case design, automation, execution)
Experience in Healthcare / Life Sciences domain
Knowledge of GxP-regulated environments
3+ years of working experience with SAP ECC and S/4HANA (functional validation across modules like SD, MM, FICO, etc.)
3+ years of experience with test management tools (e.g., JIRA, qTest, ALM)
Strong understanding of STLC, SDLC, and Agile methodologies
Experience in API testing and integration testing
Strong analytical and problem-solving skills

Job Responsibility

Design, develop, and maintain automation test scripts using TOSCA
Execute functional, regression, integration, and UAT testing
Collaborate with cross-functional teams (Business, Dev, BA, Validation teams) to ensure quality deliverables
Participate in test planning, estimation, and test case design
Work on SAP ECC and S/4HANA applications, validating end-to-end business processes
Ensure compliance with GxP, FDA 21 CFR Part 11, and other regulatory requirements
Perform test data preparation and validation
Identify defects, track them through resolution, and support root cause analysis
Contribute to automation framework improvements and best practices
Support CSV (Computer System Validation) documentation and execution activities

Fulltime

System Engineer 3

The System Engineer will analyze user’s requirements, concept of operations docu...

Location

United States , Central Maryland

Salary:

197000.00 - 227000.00 USD / Year

RealmOne

Expiration Date

Until further notice

Requirements

Twenty (20) years-experience as a SE in programs and contracts of similar scope, type and complexity is required
Bachelor’s degree in system engineering, Computer Science, Information Systems, Engineering Science, Engineering Management, or related discipline from an accredited college or university is required. Five (5) years of additional SE experience may be substituted for a bachelor’s degree
Position requires active Security Clearance with appropriate Polygraph

Job Responsibility

Analyze user’s requirements, concept of operations documents, and provide high level system architectures to develop system requirements specifications
Analyze system requirements and leads design and development activities
Guide users in formulating requirements, advise alternative approaches, and conduct feasibility studies
Provide technical leadership for the integration of requirements, design, and technology
Incorporate new plans, designs and systems into ongoing operations
Develop technical documentation
Develop system Architecture and system design documentation
Guide system development and implementation planning through assessment or preparation of system engineering management plans and system integration and test plans
Interact with the Government regarding Systems Engineering technical considerations and for associated problems, issues or conflicts
Ultimate responsibility for the technical integrity of work performed and deliverables associated with the Systems Engineering area of responsibility

What we offer

Healthcare Coverage + Insurance: Medical: Three (3) rich healthcare options through CareFirst with 100% or majority company-paid premiums. Tax-advantaged health savings account available with generous employer contribution. Dental + Vision: 100% employer-paid for employees and family, with a buy-up option available
Retirement + Savings: 401K – 10% TOTAL CONTRIBUTION – 5% safe harbor – 5% annual profit share (both immediately vested!)
Paid Time Off + More: 4 weeks starting PTO – 11 federal holidays + 2 floating holidays – Paid hours for company-required training
Career Growth + Development: Access to FREE 24/7 learning via Udemy – Opportunities to participate in tech councils, industry initiatives, etc. – $7,500 annual Educational & Professional Development Assistance
MORE BENEFITS…FOR EVERY LIFESTYLE! – Paid parental leave – Annual swag drops – Flexible work schedules -Generous referral bonus program – Employee appreciation + family-friendly corporate events …and much more

Fulltime

Principal Engineer, System Verification

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent, with approximately 10+ years of relevant industry experience
Healthcare industry experience preferred
Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel
Strong knowledge of ISO, FDA and other regulatory standards is essential
Hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data
Experience in Tools like Minitab(Data Analysis) /JIRA ( Defect )/ALM ( test Environment) etc.
Demonstrated experience working with vendors with different models of engagement
Knowledge of Design controls, lifecycle testing processes, MTBF analysis
Must have demonstrated effective supervisory and people development skills
Ability to lead teams across multiple sites

Job Responsibility

Provides technical leadership for Medication Delivery System Verification
Lead technical team members in the application of standard system engineering principles, methods, and techniques to resolve difficult problems focused on system verification
Plans and leads project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with minimal guidance
Reviews and approves verification plans and methods and provides general direction to verification engineering staff
Ensures that quality is built into the design during new product development
Reports out on the progress to senior management
Contributes to System Verification Engineering vision that aligns with the organization's vision and strategic plan
Provides direction to technical team members that are accountable for system verification engineering activities
Provide Technical direction for Systems Verification and Validation Engineering staff and programs
Lead the planning, development and execution of system verification and validation deliverables (test plans, test protocols, test cases, test reports, studies)

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Principal Engineer, System Verification

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent, with approximately 10+ years of relevant industry experience
Healthcare industry experience preferred
Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel
Strong knowledge of ISO, FDA and other regulatory standards is essential
Hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data
Experience in Tools like Minitab(Data Analysis) /JIRA ( Defect )/ALM ( test Environment) etc.
Demonstrated experience working with vendors with different models of engagement
Knowledge of Design controls, lifecycle testing processes, MTBF analysis
Must have demonstrated effective supervisory and people development skills
Ability to lead teams across multiple sites

Job Responsibility

Provide Technical direction for Systems Verification and Validation Engineering staff and programs
Lead the planning, development and execution of system verification and validation deliverables (test plans, test protocols, test cases, test reports, studies)
Contribute to the development and documentation of system requirements, systems architecture and design
Ensure appropriate traceability between system, subsystem, verification/validation and cross functional deliverables
Manage the integration of deliverables from subsystem teams, cross functional teams (risk management, compliance, etc.) and external partners
Resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory)
Implementing configuration and change management through the complete product life-cycle, including verification and validation deliverables
Actively communicates and advocates team’s capabilities and accomplishments
Recommends changes to policies and establishes procedures that affect immediate department/function
Create opportunities to automate testing and optimize test processes

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

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Life Sciences Computer System Validation Engineer

Job Description

Job Responsibility

Requirements

What we offer

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