CSV Engineer

Simotechnology; Indianapolis (IN); Hybrid; USD 90,000 - 130,000; Full time

Job summary

SimoTech in Indianapolis, Indiana, seeks an Automation CSV Engineer to join our expanding US projects team in the pharma/biotech space. You will validate computerised systems within the process automation framework, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP5, while working across DeltaV and Siemens PLC platforms.

The successful candidate will develop validation strategies, prepare documents (URS, FRS, IQ/OQ/PQ), perform PV/PQ tests, manage change controls, and support audits

Qualifications

• Bachelor's degree or higher in Engineering/IS/CS/Life Sciences.
• 5+ years' CSV Engineer experience in pharma/biotech.
• Solid knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity.
• Hands-on validation experience with DeltaV and Siemens PLC systems.

Responsibilities

• Develop and execute validation strategies for new and existing systems.
• Support validation of DeltaV, Siemens PLC, PI and other automation platforms.
• Prepare and review URS, FRS, IQ/OQ/PQ, and validation plans.
• Create traceability matrices linking requirements, design and testing.
• Perform risk and impact assessments and manage change controls.

Skills

Communication skills

Stakeholder management

Independent work

Team collaboration

Education

Bachelor's degree in Engineering/IS/CS/Life Sciences

Tools

DeltaV

Siemens PLC

Job description

• Industry Pharma/Biotech/Clinical Research
• City Indianapolis
• Province Indiana
• Country United States

Job Description

Why SimoTech

What is it like towork at SimoTech? With a strong collaborative teamwork culturebased on respect, trust, and excellence, we play a criticalpartnering role in our clients’ life-changing supply of productsto patients. In return, there is an excellent salary, benefits,career progression, educational support and much more.

We are activelyexpanding our US projects team to support a growing portfolio of pharmaceuticaland biotechnology projects across the United States. SimoTech is seeking anAutomation CSV Engineer to join our team. The successfulcandidate will support the validation of computerised systems within theprocess automation framework, ensuring their compliance with pharmaceuticalindustry standards and regulations. The ideal candidate will have extensiveexperience as a CSV Engineer in a pharmaceutical environment.

Key Responsibilities

• Developand execute validation strategies for new and existing process automation andcomputerised systems.
• Supportthe implementation and validation of DeltaV, Siemens PLC, PI and otherautomation platforms.
• Prepareand review validation documents including URS, FRS, IQ, OQ, PQ, ValidationPlans, Summary Reports and Automation Change Pack (ACP’s).
• Developand execute PV and PQ protocols to support readiness for commercialmanufacturing.
• Performrisk assessments, impact assessments, and manage change controls for validatedsystems.
• Createand maintain traceability matrices ensuring full alignment betweenrequirements, design, and testing.
• Identify,troubleshoot, and resolve validation deviations and test failures in a timelymanner.
• Executecommissioning and qualification test cases to verify system functionality anddata integrity.
• Supportinternal audits, inspection readiness, and preparation activities forregulatory licensure (HPRA, EMA, FDA).
• Ensureall validation work complies with 21 CFR Part 11, GAMP 5, EU Annex 11, and sitequality standards.
• Collaboratewith IT QA to ensure compliance and drive continuous improvement in validationprocesses.
• Providevalidation and regulatory training to team members to support the transitionfrom project phase to operations.

Requirements

Key Requirements

• Bachelor’sDegree in Engineering, Information Systems, Computer Science or Life Sciences.
• Minimumof 5 years’ experience as a CSV Engineer in a pharmaceutical environment.
• Experiencesupporting process automation systems and manufacturing technologies from a CSVperspective.
• Good knowledge of 21 CFR Part11, EU Annex 11, GAMP5 and data integrity guidelines.
• Handson experience validating DeltaV and Siemens PLC automated systems.
• ExcellentCommunication and stakeholder management skills
• Ability towork independently while contributing effectively within a team environment
• Eligibilityto work in the United States.

WhatSimoTech Can Offer

• Opportunityto work with large corporate clients on exciting capital projects.
• Role provides a high degree of autonomy to allow the successfulcandidate to reach their full potential.
• Developnew skills and enhance technical ability by working with innovativetechnologies in
• We offera hybrid working model for this role, balancing flexibility with businessneeds.

AdditionalInformation

SimoTech is proud tobe an EEO Employer and does not discriminate on the basis of age, race, colour,religion, gender identity, sex, gender expression, sexual orientation, geneticinformation, ancestry, national origin, protected veteran status, disability,or any other legally protected status