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Computer System Validation Manager Jobs in Indiana

Catalyx

Automation Project Lead

Indianapolis, IN

$90.80K - $119K/yr

... and computer system validation principles Strong knowledge of GMP's, regulatory requirements and computer system validation principles Excellent written and verbal communication skills for both ...

Visium Resources, Inc.

Be Seen First

Project Manager - Senior CQV Pharmaceutical

Indianapolis, IN · On-site

Automation systems * Manufacturing processes * Experience authoring and reviewing validation lifecycle documentation. * Demonstrated success leading cross-functional teams and managing multiple ...

New

INCOG

Senior MES Engineer

Fishers, IN

$97.80K - $134.30K/yr

... and ongoing management of Manufacturing Execution System (MES) platforms to ensure seamless ... Provide technical support to Computer System Validation (CSV) activities, including MES ...

Beth Page tech

Technical Manager

Indianapolis, IN · On-site

Technical Manager Location: Indianapolis, IN (Hybrid) Duration: 2+ Years Job Summary: The Program ... Strong knowledge of GMP's, regulatory requirements and computer system validation principles.

Catalyx

Automation PLC Lead

Indianapolis, IN · Hybrid

... computer system validation deliverables (alarm rationalization, system overview, source code reviews, testing, etc.) Secure vendor documents for skidded equipment to integrate with validation ...

E Solutions

GMP Engineer

Indianapolis, IN · On-site

Support internal and external audits related to system validation and regulatory compliance ... Bachelor's degree in Engineering, Science, Business, Management, or a related field . * Minimum of ...

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN

$94.10K - $129.20K/yr

... and ongoing management of Manufacturing Execution System (MES) platforms to ensure seamless ... Computer System Validation (CSV) activities, including MES qualification and data integrity ...

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN · On-site

$97.80K - $134.30K/yr

... and ongoing management of Manufacturing Execution System (MES) platforms to ensure seamless ... Computer System Validation (CSV) activities, including MES qualification and data integrity ...

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN · On-site

$94.10K - $129.20K/yr

... and ongoing management of Manufacturing Execution System (MES) platforms to ensure seamless ... Computer System Validation (CSV) activities, including MES qualification and data integrity ...

EXOS

SR. CSV Specialist

Indianapolis, IN

The Senior Computer Systems Validation Specialist focused on Building Management Systems to support a regulated pharmaceutical manufacturing environment. The specialist will support a Site Automation ...

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Computer System Validation Manager information

See Indiana salary details

$45.2K

$100.3K

$152.7K

How much do computer system validation manager jobs pay per year?

As of May 30, 2026, the average yearly pay for computer system validation manager in Indiana is $100,309.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,900.00 and $125,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Indiana? The most popular types of Computer System Validation jobs in Indiana are:
What are popular job titles related to Computer System Validation Manager jobs in Indiana? For Computer System Validation Manager jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Indiana look for? The top searched job categories for Computer System Validation Manager jobs in Indiana are:
What cities in Indiana are hiring for Computer System Validation Manager jobs? Cities in Indiana with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Indiana as of May 2026, with employment types broken down into 24% Full Time, 68% Part Time, and 8% Contract. Highlights an 85% Physical, and 15% Remote job distribution, with an average salary of $100,309 per year, or $48.2 per hour.

Automation Project Lead

Catalyx

Indianapolis, IN

$90.80K - $119K/yr

Full-time

Posted 16 days ago

Job description

Catalyx is seeking a DeltaV Automation Lead who will be responsible for the control system solution for an area within a project ensuring the solution is aligned with the overall program automation philosophy, standards and user requirements. Role Responsibilities: Technical ownership for an area in a project Define the S88 software structure and list for the area Develop draft function design specifications for the area Work with system integrators to finalize the functional specifications Participate in P&ID and control strategy reviews Working closely with the Project Technical Lead and System Integrator to successfully deliver the project on schedule and budget Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards Ensure consistency of the automation deliverables in the area (requirements, functional specifications, control strategies, phases, and recipes, etc.) Assist in defining the software components that need to be created or modified Communicate progress, issues, and needs to automation technical lead for the project Provide input, review, and approve functional requirements and specifications Develop Parameter and Recipe Specification documents Responding to system integrator technical queries Identification of any remediation effort required on process control software Create items in the issue tracker as issues arise after the software acceptance Identify and analyze risks of technical nature particular to the area and planning responses Requirements BS Engineering (or equivalent experience) 8+ years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing) Previous Pharmaceutical Automation Large Project/Program experience/expertise 5+ years' experience in DeltaV Batch DCS Preferable previous experience with Allen-Bradley PLCs Strong knowledge of GMP's, regulatory requirements and computer system validation principles Strong knowledge of GMP's, regulatory requirements and computer system validation principles Excellent written and verbal communication skills for both technical and non-technical audiences Why Join Catalyx. At Catalyx we understand that our people are our greatest asset

For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law.

We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone. At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.

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