Csv Engineer Job at S.T.B. ValiTech S.r.l. (Sabaudia)

Life sciences Computer System Validation Engineer

As a quality and compliance expert, you will be responsible for ensuring that Gx...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Proven CSV experience in multiple projects or strong interest in CSV
Strong affinity with IT
Analytical and pragmatic thinking skills
Strong prioritization and planning skills
Strong sense of responsibility and accountability
A positive, solution-driven mindset
Excellent written and oral communication skills in Dutch and English
Basic knowledge of IT infrastructure qualification
A team player, but also able to work independently
Familiar with applicable regulatory standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,...

Job Responsibility

Ensure that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle
Stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO
Provide Quality & Compliance support during audits and inspections
Join a Sopra Steria validation service team
Ensure the quality and regulatory compliance of GxP systems throughout their entire life cycle and across all GxP areas (GLP, GCP, GMP, GDP, GPvP)

What we offer

Mobility options (including a company car)
Insurance coverage
Meal vouchers
Eco-cheques
Continuous learning opportunities through the Sopra Steria Academy
Opportunity to connect with fellow Sopra Steria colleagues at various team events

Life Sciences Computer System Validation Engineer

As a V.I.E. in the Life Sciences division, you will support the validation and c...

Location

Belgium

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Strong interest in CSV
strong affinity with IT
analytical and pragmatic thinking skills
strong prioritization and planning skills
strong sense of responsibility and accountability
a positive, solution-driven mindset
excellent written and oral communication skills in English
basic knowledge of IT infrastructure qualification
a team player, but also able to work independently
familiar with applicable regulatory standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,...

Job Responsibility

Support the validation and compliance of computerized systems used in regulated environments
ensure GxP systems meet regulatory standards throughout their lifecycle
contribute to audits
stay informed on evolving regulations (EMA, FDA, GAMP, ISO)
work closely with Sopra Steria’s validation service teams.

What we offer

An international experience: be part of an innovative company with global reach
a stimulating environment: work on ambitious projects and collaborate with industry experts
a dynamic company culture: join a human-sized team within a large group
career growth opportunities: potential for long-term career development in Canada or within the Sopra Steria Group.

Fulltime

Senior Validation Engineer

Master Compliance, Inc. in Irving, TX is seeking Senior Validation Engineer(s) t...

Location

United States , Irving

Salary:

108722.00 USD / Year

Master Compliance Inc

Expiration Date

Until further notice

Requirements

Master’s degree in Electrical/Electronic Engineering, Energy Management, or any related field of study and 1-year of experience in the job offered or in any related position(s) in which the required experience was gained
Engineering principles and concepts relevant to validation processes
Industry regulations and standards (FDA, ISO, or GMP)
Validation documentation, including protocols, reports, and test plans
Validation testing, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/ Performance Qualification)
Analyze and interpret validation data, ensuring compliance with established criteria and specifications
Risk assessments related to validation processes and develop mitigation strategies
Quality management principles and validation activities to meet quality standards
Validation equipment and instrumentation
Develop and execute validation protocols for equipment, processes, or systems

Job Responsibility

Lead the IT Validation activities for cloud based computerized systems and applications
Manage end to end validation documentation validation plan, training plan, issues log, design review, IQ protocol/report, OQ protocol/ report, PQ protocol/ report, test cases, test incidents, trace matrix, change controls and validation report
Author and manage the documents required for the development and validation of client’s cloud-based computerized systems, applications, and software
Follow the client validation procedures and requirements in validating new or modified processes and/or systems
Represent validation team in Business workshops, requirement gathering sessions and develop user requirements, system requirements including system flow diagram specifications, configuration, and design specifications
Manage and Plan for all validation testing activities (OQ, PQ and pre-validation UAT protocols) and lead deviation management activities
Develop test strategy and plan in execution of operational and performance protocols
Implement risk based approach and ensure validation tasks are aligned with healthcare regulations and clients SOPS
Lead change control management , Deviation Management ,APA’s investigation
Gather CSV metrics for reporting purposes

Fulltime

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

Csv Junior Engineer

We are seeking a CSV Junior Engineer to support validation activities at one of ...

Location

Italy , Rome

Salary:

Not provided

S.T.B. ValiTech S.r.l.

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Engineering or scientific fields is required
0-3 years of experience in CSV, QA, IT/OT systems, automation, or other GxP‑related activities (internships included)
Good knowledge of English (written and spoken)
Proficiency in Microsoft Office
Strong motivation to grow in validation and regulatory compliance areas
Ability to work in a team and follow established procedures
Availability to travel frequently across Italy for project needs
Fluent Italian (mandatory)

Job Responsibility

Support the execution of qualification activities (IQ/OQ) for standalone and networked computerized systems
Assist in drafting System Configuration documents
Provide operational support to the client for IT infrastructure migration activities
Contribute to the preparation and execution of qualification protocols (FAT, SAT, IQ, OQ, PQ)
Support validation planning for computerized systems
Help in conducting Risk Assessments (RA, Process Mapping)
Draft and update Standard Operating Procedures (SOPs)

What we offer

Competitive compensation based on experience
Meal voucher / client’s canteen
A company car is available for client‑site travel and can be picked up from our headquarters in Sabaudia (LT)
Smart working for agreed-upon CSV tasks
Continuous professional development and long-term career progression
Exposure to top-tier industry clients and innovative technologies

Fulltime

New

CSV Engineer

We are looking for a CSV Engineer to support a pharma project at a manufacturing...

Location

Netherlands , Boxmeer

Salary:

75000.00 - 80000.00 EUR / Year

Algoteque

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Computer Science, or another technical discipline
Experience working with automated systems and a solid understanding of automation fundamentals
Strong knowledge of cGMP, CSV, and SDLC methodologies
Excellent problem-solving, facilitation, and decision-making skills
Proven ability to analyze business problems, build business cases, and identify suitable process and technology solutions
Experience integrating vendor-packaged systems or equipment into a digital manufacturing environment

Job Responsibility

Support the operation and validation of automated systems within a pharmaceutical GMP environment
Apply CSV and SDLC methodologies to ensure systems comply with regulatory and quality standards
Analyze business and process requirements and contribute to effective technical solutions
Support the integration of vendor-packaged equipment into the site's digital and automation landscape
Collaborate with cross-functional teams to drive continuous improvement using LEAN/MPS/Six Sigma principles
Facilitate workshops, support decision-making, and contribute to validation and compliance documentation

Fulltime

Csv engineer

We are looking for a CSV Engineer to support a pharma project at a manufacturing...

Location

Netherlands , Boxmeer

Salary:

75000.00 - 80000.00 EUR / Year

Algoteque

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Computer Science, or another technical discipline
Experience working with automated systems and a solid understanding of automation fundamentals
Strong knowledge of cGMP, CSV, and SDLC methodologies
Excellent problem-solving, facilitation, and decision-making skills
Proven ability to analyze business problems, build business cases, and identify suitable process and technology solutions
Experience integrating vendor-packaged systems or equipment into a digital manufacturing environment

Job Responsibility

Support the operation and validation of automated systems within a pharmaceutical GMP environment
Apply CSV and SDLC methodologies to ensure systems comply with regulatory and quality standards
Analyze business and process requirements and contribute to effective technical solutions
Support the integration of vendor-packaged equipment into the site's digital and automation landscape
Collaborate with cross-functional teams to drive continuous improvement using LEAN/MPS/Six Sigma principles
Facilitate workshops, support decision-making, and contribute to validation and compliance documentation

Fulltime

New

CSV Engineer III

We’re looking for a CSV Validation Engineer III to join our Quality and Complian...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

5+ years of hands-on experience in a cGMP-regulated environment
At least 3 years focused on automation and validation
Strong knowledge of validation for manufacturing equipment, utilities, clean media systems, and facilities
Experience with industry standards like GAMP and regulations including 21 CFR Part 11, 210, 211, 820, and ICH Q7A
A deep understanding of system risk assessments, gap analysis, and remediation plans
Excellent communication and documentation skills
Team-first mindset with the ability to work independently on multiple complex projects
Proficiency in Microsoft Office and database systems

Job Responsibility

Lead validation activities throughout the computer system lifecycle
Develop test strategies, perform system assessments, and execute validation protocols for GxP systems and infrastructure
Ensure compliance with FDA (21 CFR Part 11, 820), cGMP, and global industry regulations
Collaborate cross-functionally with Manufacturing, QA, IT, and Engineering teams
Execute change controls and revalidation projects across systems such as PCS, BMS, CMS, OSI PI, and automation platforms
Train colleagues and contractors on best practices for computer system implementation and validation
Support periodic reviews and ensure the continued compliance of validated systems post-Go-Live

What we offer

A collaborative work environment where your ideas matter
Opportunities for cross-functional growth and leadership
Competitive compensation and benefits
A chance to shape critical systems that directly impact patient safety and product quality

Fulltime

Csv Engineer

S.T.B. ValiTech S.r.l.

Location:
Italy , Sabaudia

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 21, 2026

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Life sciences Computer System Validation Engineer