CSV Engineer Job at Algoteque (Boxmeer)

Csv Engineer

We are seeking a CSV Engineer with proven experience to manage validation delive...

Location

Italy , Sabaudia

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
3-5 years of hands‑on experience in Computer System Validation within pharmaceutical, biotech, or other GxP‑regulated industries
Solid knowledge of GAMP 5 and Data Integrity principles
Proficiency in Microsoft Office
Availability to travel nationwide based on project requirements
Fluent Italian (mandatory)
Good English knowledge (written and spoken)

Job Responsibility

Lead and execute qualification activities (FAT, SAT, IQ, OQ, PQ) for standalone and networked computerized systems
Draft and review System Configuration and system lifecycle documentation
Develop Computer System Validation Plans and Validation Reports
Drive Risk Assessment activities (RA, Data Integrity, Process Mapping)
Write and revise SOPs related to CSV and Data Integrity
Collaborate directly with client stakeholders (Engineering, QA, IT, Production)
Review Functional Specifications (FS), Hardware Design Specifications (HDS), Software Design Specifications (SDS), and Configuration Specifications (CS) provided by suppliers or system developers
Ensure alignment between user requirements, system design, and validation deliverables

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 authorized by the company for CSV activities suitable for remote execution
Continuous professional development and long-term career progression
Exposure to top-tier industry clients and innovative technologies

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

CSV Engineer IV

The CSV Validation Engineer IV is responsible for authoring and reviewing valida...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Ten plus (10+) years of relevant computer systems validation, project management or operations experience within a cGMP environment, with at least 5 years of recent validation/engineering experience
Computer systems validation experience for GMP manufacturing, laboratory, quality, as well as utilities, and facilities
Experience in the biotechnology and/medical or pharmaceutical industry
Proficiency of Computers Systems Validation and Quality Systems
Good understanding of software supporting automated systems, laboratory equipment, and quality systems
Knowledge regulatory guidelines including 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GAMP
Experience in thorough testing of applications, computerized systems, changes and implementations
Excellent written and oral communication to include accurate and legible documentation skills
Ability to work in a fast-paced environment
Team oriented

Job Responsibility

Author and review validation deliverables within the Computer System Lifecycle (e.g. Validation Plans, SOPs, Protocols, Trace Matrix, Assessments, and Reports)
Participate in developing and revising validation procedures and protocols to meet regulatory requirements and site quality and validation procedures
Interact with CSV Management to prioritize and/or harmonize activities
Participate in multi-site CSV initiatives through document development or other validation activities
Author, review and approve system assessments, test documents, change controls, process improvements and compliance governance at all applicable points of the system life cycle for all PCI sites
Serve as the SME to provide compliance leadership and oversight for CSV projects
Collaborate with departments within the organization to maintain and improve computerized system validation processes
Generate, review and approve local validation and compliance documents supporting GxP computerized and computer systems, and relevant infrastructure
Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls
Execute validation protocols

Fulltime

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 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

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

New

AWS Data Engineer

Join us as an AWS Data Engineer Barclays, responsible for supporting the success...

Location

India , Pune

Salary:

Not provided

Barclays

Expiration Date

Until further notice

Requirements

Firsthand Experience in developing, testing and maintaining applications on AWS Cloud
Strong hands‑on experience with the AWS Data Analytics stack (Amazon S3, AWS Glue, Athena, Lambda, IAM, Lake Formation, KMS, STS, and Step Functions), with a proven ability to build, test, and support secure, scalable, and well‑governed data pipelines
Firsthand experience in Airflow and PySpark and strong knowledge of Python
Design and implement scalable and efficient data transformation/storage solutions using Snowflake
Experience in Data ingestion to Snowflake for different storage format such Parquet, Iceberg, JSON, CSV etc
Experience in using DBT (Data Build Tool) with snowflake for ELT pipeline development
Experience in Writing advanced SQL and PL SQL programs
Experience in AWS data pipeline development
HandsOn Experience for building reusable components using Snowflake and AWS Tools/Technology
Must have completed two major projects

Job Responsibility

Build and maintenance of data architectures pipelines that enable the transfer and processing of durable, complete and consistent data
Design and implementation of data warehoused and data lakes that manage the appropriate data volumes and velocity and adhere to the required security measures
Development of processing and analysis algorithms fit for the intended data complexity and volumes
Collaboration with data scientist to build and deploy machine learning models

What we offer

Competitive holiday allowance
Life assurance
Private medical care
Pension contribution

Fulltime

Sr. Engineer/Lead Engineer MDM

Sponsorship:  GM DOES NOT PROVIDE IMMIGRATION-RELATED SPONSORSHIP FOR THIS ROLE....

Location

India , Bengaluru

Salary:

Not provided

General Motors

Expiration Date

Until further notice

Requirements

Bachelor's degree in Mechanical / Production / Industrial / Automobile Engineering
Good knowledge of Automotive Vehicle / Body-In-white processes and product launch
Good knowledge of Teamcenter, NX, Vismockup, AutoCAD, MS Project, and MS Office applications
Sound understanding of GVDP (Vehicle development processes) , Quality Chain & PFMEA
Sound knowledge of Project Management methodologies (Waterfall, Agile)
Sound knowledge of GM-GMS (Lean manufacturing processes) Principles and Workplace safety systems
Basic Manufacturing Process and concept
Communication skills (verbal and written)
Learning Agility
Interpersonal, Problem solving & Analytical skills

Job Responsibility

Learn GM Global Standards for BIW Assembly Updates
Analyze inputs like Product, Weld, Sealer, Assembly Sequence chart, In house and Outsource strategy, information received from stakeholders & create Items for MDM, Product, Weld, Datum in Teamcenter as per GM global standards
Generate the required output/deliverables (Product Overlays, Weld consistency report, Datum consistency report, Product, Weld Issues ppt, Product Issue (Installation Assembly) checklist)
Create the Datums and assign the attributes as per the Concept sheets
Perform the Datum Consistency check
Knowledge of Creating assembly Sequence structure Views as per Concept Sheets(ASKF sheet)
Take the CSV report to check all the attributes
Datum Synchronization & Perform DCS and Checkmate
Flawless communication within team for project support & updates
Mention the Change description note

Fulltime

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CSV Engineer

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