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Biotech Csv Jobs in Indiana (NOW HIRING)

INCOG

Senior MES Engineer

Fishers, IN

$97K - $134K/yr

Provide technical support to Computer System Validation (CSV) activities, including MES ... Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic ...

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN · On-site

$97K - $134K/yr

... CSV) activities, including MES qualification and data integrity assessments. • Work closely with ... biotechnology products, aseptic processing (fill and finish), and process development. • ...

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN

$94K - $129K/yr

... CSV) activities, including MES qualification and data integrity assessments. · Work closely with ... biotechnology products, aseptic processing (fill and finish), and process development. • ...

INCOG BioPharma Services

Senior MES Engineer

Fishers, IN · On-site

$94K - $129K/yr

... CSV) activities, including MES qualification and data integrity assessments. · Work closely with ... Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic ...

Elanco

Process Automation Engineer

Clinton, IN

Experience in a regulated manufacturing environment (pharma, biotech, food, or similar) * Knowledge of computer system validation (CSV) and change control practices * Experience supporting ...

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Biotech Csv information

What are some common challenges faced by Biotech CSV professionals when ensuring compliance with regulatory standards?

Biotech CSV (Computer System Validation) professionals often encounter challenges such as keeping pace with evolving regulatory requirements and ensuring that validation documentation is both thorough and audit-ready. Navigating the complexity of integrating new software or technologies into existing validated systems can also be demanding. Effective communication with cross-functional teams—such as quality assurance, IT, and laboratory staff—is crucial to address gaps and maintain compliance. Staying organized and proactive in risk management helps CSV professionals overcome these hurdles and support successful regulatory inspections.

What are Biotech CSV professionals?

Biotech CSV (Computer System Validation) professionals are experts who ensure that computerized systems used in biotechnology and pharmaceutical industries meet regulatory requirements and function as intended. They are responsible for planning, executing, and documenting validation activities to ensure data integrity, product quality, and compliance with standards such as FDA 21 CFR Part 11. Their role is crucial in maintaining reliable and compliant technology solutions throughout the product lifecycle, helping companies avoid costly errors and regulatory penalties.

What are the key skills and qualifications needed to thrive as a Biotech CSV (Computer System Validation) Specialist, and why are they important?

To thrive as a Biotech CSV Specialist, you need a solid understanding of computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, quality management systems (QMS), and relevant software like TrackWise or MasterControl is crucial. Strong analytical thinking, attention to detail, and effective communication are standout soft skills in this role. These skills and qualities ensure validated systems meet regulatory standards, minimize compliance risks, and support reliable biotech research and manufacturing processes.
What are popular job titles related to Biotech Csv jobs in Indiana? For Biotech Csv jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Biotech Csv jobs in Indiana look for? The top searched job categories for Biotech Csv jobs in Indiana are:
What cities in Indiana are hiring for Biotech Csv jobs? Cities in Indiana with the most Biotech Csv job openings:
Biotech Csv jobs near you
Infographic showing various Biotech Csv job openings in Indiana as of July 2026, with employment types broken down into 90% Full Time, 2% Part Time, 1% Temporary, and 7% Contract. Highlights an 80% Physical, 4% Hybrid, and 16% Remote job distribution.

CSV Lead - (Delta-V and Rockwell)

IT MINDS L.L.C.

Indianapolis, IN • On-site

$98K - $129K/yr

Contractor

Re-posted 10 days ago

Job description

Role: CSV Lead
Location: IN, CA, NC and DE (Multiple locations)

Required:

DeltaV and Rockwell

About the Project:

We are looking for an experienced Computer System Validation (CSV) Lead to oversee automation systems validation for utilities at a large-scale greenfield pharmaceutical manufacturing facility. This site will feature monoclonal antibody (mAb) and bioconjugate production, along with key infrastructure including a central utility plant (CUP), administration and laboratory buildings, and tank farm systems.

The CSV Lead will provide technical leadership and manage all CSV activities for automation systems related to utilities and supporting infrastructure, ensuring compliance with regulatory standards and project deadlines.

Key Responsibilities:

  • Lead and manage CSV activities for automation systems supporting utilities such as CUP, tank farm, and administrative/laboratory systems.
  • Develop and implement validation strategies, plans, and protocols (IQ, OQ, PQ) following GAMP 5 and regulatory guidelines.
  • Oversee preparation and review of validation documentation including risk assessments, test scripts, and traceability matrices.
  • Collaborate closely with automation engineers, quality assurance, and project management teams to ensure timely and compliant completion of validation activities.
  • Maintain compliance with GMP, 21 CFR Part 11, and data integrity standards throughout the system lifecycle.
  • Support audits and inspections related to CSV and automation compliance.

Qualifications:

  • Bachelor’s degree in Engineering, Computer Science, or related field.
  • 8+ years of experience in computer system validation within pharmaceutical or biotech manufacturing.
  • Deep knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles.
  • Proven experience validating automation platforms such as DeltaV and Rockwell and related infrastructure.
  • Familiarity with electronic documentation and compliance systems such as Kneat.
  • Experience with greenfield or large-scale capital projects is a plus.
  • Understanding of utilities automation and control system architecture is beneficial.

Best Regards,

 

Satya Satish J | Technical Recruiter | IT Minds LLC |