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CSV Engineer at ALLIANCE BIOTECH SOLUTIONS LLC
Raleigh, North Carolina, United States - Full Time
Skills Needed
Computer System Validation, Sql, Gamp 5, 21 Cfr Part 11, Eu Annex 11, Alcoa+ Data Integrity, Power Bi, Azure Data Lake, Databricks, Synapse, Software Development Lifecycle, Risk Assessment, Iq/Oq/Pq Protocols, Data Reconciliation, Api Validation, Gxp Compliance
Specialization
Requires a Bachelor's degree in a technical field and over 7 years of CSV experience in pharmaceutical or biotech industries. Must possess strong knowledge of SQL, relational databases, and regulatory standards such as GAMP 5 and 21 CFR Part 11.
Experience Required
Minimum 5 year(s)
NPI Engineer at Beagle HR
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
HSE Engineer at Indeed
Dubai, Abu az Zuluf, United Arab Emirates - Full Time
Skills Needed
N/A
HSE Engineer at Speedex International
Dubai, Abu az Zuluf, United Arab Emirates - Full Time
Skills Needed
N/A
RTL Engineer at Dabster
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
LLM Engineer at Datacation B.V.
Drenthe, Drenthe, Netherlands - Full Time
Skills Needed
N/A
MEP Engineer at Egis Group
Bengaluru, karnataka, India - Full Time
Skills Needed
Mechanical Engineering, Electrical Engineering, Mep Design, Autocad, Revit Mep, Dialux, Caneco, Project Management, Technical Specification Development, French Building Codes, Leadership, Multidisciplinary Coordination
Specialization
Requires a Bachelor's or Master's degree in Mechanical or Electrical Engineering with at least 8 years of design experience in the building sector. Proficiency in MEP software and familiarity with French building codes are highly desired.
Experience Required
Minimum 5 year(s)
SOC Engineer at 4square-recruitment
london, Devon - England, United Kingdom - Full Time
Skills Needed
N/A
SOC Engineer at Proactive Appointments
london, Devon - England, United Kingdom - Full Time
Skills Needed
N/A
iOS Engineer at Depop
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
QA Engineer at Harnham
London, Kent - England, United Kingdom - Full Time
Skills Needed
N/A
AI Engineer at Trader Interactive
Ontario, Ontario, Canada - Full Time
Skills Needed
N/A
HSE Engineer at indeed
Dubai, Abu Dhabi, United Arab Emirates - Full Time
Skills Needed
N/A
QA Engineer at SET2RECRUIT LTD
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
SRE Engineer at Blue Ant International Ltd United Kingdom
dubai, Abu Dhabi, United Arab Emirates - Full Time
Skills Needed
N/A
IAM Engineer at Odevo
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
RMC Engineer at ADANI GLOBAL PTE LTD
Visakhapatnam, Andhra Pradesh, India - Full Time
Skills Needed
Production Management, Quality Control, Equipment Maintenance, Resource Planning, Concrete Production, Project Specifications, Safety Regulations, Cost Optimization, Stakeholder Coordination
Specialization
Candidates must hold a B.Tech or Diploma in Civil or Mechanical Engineering. A minimum of 5 years of experience within the precast industry is required.
Experience Required
Minimum 5 year(s)
AI Engineer at XpertDirect
Switzerland, Manitoba, Switzerland - Full Time
Skills Needed
N/A
AI Engineer at DOUGLAS GROUP
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
LLM Engineer at DAINAN TECH S PTE LTD
berlin, Berlin, Germany - Full Time
Skills Needed
N/A
CSV Engineer at ALLIANCE BIOTECH SOLUTIONS LLC
Raleigh, North Carolina, United States -
Full Time


Start Date

Immediate

Expiry Date

16 Oct, 26

Salary

0.0

Posted On

18 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Computer System Validation, SQL, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity, Power BI, Azure Data Lake, Databricks, Synapse, Software Development Lifecycle, Risk Assessment, IQ/OQ/PQ Protocols, Data Reconciliation, API Validation, GxP Compliance

Industry

Business Consulting and Services

Description
Description The Senior Computer System Validation (CSV) Engineer is responsible for leading the validation of complex computerized systems, custom-developed applications, enterprise databases, data platforms, and business intelligence solutions used within regulated GxP environments. This role partners with IT, Software Development, Data Engineering, Manufacturing, Quality, and business stakeholders to ensure that custom software applications, databases, reporting platforms, and system integrations are designed, validated, and maintained in compliance with regulatory requirements and industry best practices. This position requires an experienced validation professional who is equally comfortable discussing validation strategy with Quality, reviewing software architecture with developers, validating SQL queries and database structures, and ensuring the integrity of data flowing between enterprise systems. The successful candidate will lead validation efforts across the full software development lifecycle, with particular emphasis on custom applications, relational databases, enterprise data warehouses/lakehouses, data pipelines, APIs, and business intelligence platforms that support manufacturing, laboratory, and business operations. Requirements · Lead Computer System Validation (CSV) activities for custom-developed applications, enterprise databases, data platforms, dashboards, and other GxP computerized systems. · Partner with software developers, data engineers, IT, Quality, and business stakeholders to define validation strategies and ensure compliance throughout the software development lifecycle. · Author and execute validation deliverables including Validation Plans, URS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, test scripts, and Validation Summary Reports. · Validate custom applications, Power BI dashboards, enterprise databases, and cloud-based data platforms while performing SQL-based testing, data reconciliation, and verification activities. · Validate system integrations, data pipelines, APIs, and interfaces between enterprise applications including LIMS, MES, ERP, PI Historian, and related GxP systems. · Verify data integrity, security, audit trail, and electronic records controls to ensure compliance with GxP and regulatory requirements. · Support audit readiness by maintaining compliant validation documentation and providing technical leadership on CSV, CSA, database validation, and data integrity best practices. Experience & Skills · Bachelor's degree in Engineering, Computer Science, Information Systems, Software Engineering, Life Sciences, or a related technical discipline. · 7+ years of Computer System Validation (CSV) experience supporting custom software applications, enterprise databases, data platforms, and computerized systems within pharmaceutical, biotechnology, medical device, or other regulated industries. · Demonstrated experience validating custom-developed applications, database-driven systems, enterprise integrations, and business intelligence platforms such as Power BI. · Strong knowledge of relational databases, SQL, data architecture, data validation methodologies, and cloud-based data platforms such as Azure Data Lake, Databricks, Synapse, OneLake, SQL Server, Oracle, PostgreSQL, or similar technologies. · Thorough understanding of GAMP 5, Computer Software Assurance (CSA), 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity principles, and cGMP regulations. · Experience leading validation efforts across the software development lifecycle, including requirements, risk assessments, testing, documentation, and audit readiness. · Excellent analytical, troubleshooting, communication, and cross-functional collaboration skills. Benefits & Compensation • Industry competitive wage as a full-time employee • Flexible Paid Time Off • Bonus plans • Medical, Dental and Vision Insurance with low employee cost • Employer paid long term and short-term disability • 401k plan with employer contributions About Alliance Biotech Solutions Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success. Alliance Biotech Solutions is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation. Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee. All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Responsibilities
Lead the validation of complex computerized systems, custom applications, and data platforms within regulated GxP environments. Partner with cross-functional teams to ensure software architecture and data pipelines comply with regulatory requirements and industry best practices.
CSV Engineer at ALLIANCE BIOTECH SOLUTIONS LLC
Raleigh, North Carolina, United States - Full Time
Skills Needed
Computer System Validation, Sql, Gamp 5, 21 Cfr Part 11, Eu Annex 11, Alcoa+ Data Integrity, Power Bi, Azure Data Lake, Databricks, Synapse, Software Development Lifecycle, Risk Assessment, Iq/Oq/Pq Protocols, Data Reconciliation, Api Validation, Gxp Compliance
Specialization
Requires a Bachelor's degree in a technical field and over 7 years of CSV experience in pharmaceutical or biotech industries. Must possess strong knowledge of SQL, relational databases, and regulatory standards such as GAMP 5 and 21 CFR Part 11.
Experience Required
Minimum 5 year(s)
NPI Engineer at Beagle HR
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
HSE Engineer at Indeed
Dubai, Abu az Zuluf, United Arab Emirates - Full Time
Skills Needed
N/A
HSE Engineer at Speedex International
Dubai, Abu az Zuluf, United Arab Emirates - Full Time
Skills Needed
N/A
RTL Engineer at Dabster
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
LLM Engineer at Datacation B.V.
Drenthe, Drenthe, Netherlands - Full Time
Skills Needed
N/A
MEP Engineer at Egis Group
Bengaluru, karnataka, India - Full Time
Skills Needed
Mechanical Engineering, Electrical Engineering, Mep Design, Autocad, Revit Mep, Dialux, Caneco, Project Management, Technical Specification Development, French Building Codes, Leadership, Multidisciplinary Coordination
Specialization
Requires a Bachelor's or Master's degree in Mechanical or Electrical Engineering with at least 8 years of design experience in the building sector. Proficiency in MEP software and familiarity with French building codes are highly desired.
Experience Required
Minimum 5 year(s)
SOC Engineer at 4square-recruitment
london, Devon - England, United Kingdom - Full Time
Skills Needed
N/A
SOC Engineer at Proactive Appointments
london, Devon - England, United Kingdom - Full Time
Skills Needed
N/A
iOS Engineer at Depop
London, London - England, United Kingdom - Full Time
Skills Needed
N/A
QA Engineer at Harnham
London, Kent - England, United Kingdom - Full Time
Skills Needed
N/A
AI Engineer at Trader Interactive
Ontario, Ontario, Canada - Full Time
Skills Needed
N/A
HSE Engineer at indeed
Dubai, Abu Dhabi, United Arab Emirates - Full Time
Skills Needed
N/A
QA Engineer at SET2RECRUIT LTD
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
SRE Engineer at Blue Ant International Ltd United Kingdom
dubai, Abu Dhabi, United Arab Emirates - Full Time
Skills Needed
N/A
IAM Engineer at Odevo
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
RMC Engineer at ADANI GLOBAL PTE LTD
Visakhapatnam, Andhra Pradesh, India - Full Time
Skills Needed
Production Management, Quality Control, Equipment Maintenance, Resource Planning, Concrete Production, Project Specifications, Safety Regulations, Cost Optimization, Stakeholder Coordination
Specialization
Candidates must hold a B.Tech or Diploma in Civil or Mechanical Engineering. A minimum of 5 years of experience within the precast industry is required.
Experience Required
Minimum 5 year(s)
AI Engineer at XpertDirect
Switzerland, Manitoba, Switzerland - Full Time
Skills Needed
N/A
AI Engineer at DOUGLAS GROUP
Berlin, Berlin, Germany - Full Time
Skills Needed
N/A
LLM Engineer at DAINAN TECH S PTE LTD
berlin, Berlin, Germany - Full Time
Skills Needed
N/A
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