... Contract Interview Mode: Onsite (Local candidates preferred) Job Summary: We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification ...
Quick apply
... Contract Interview Mode: Onsite (Local candidates preferred) Job Summary: We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification ...
Automation Engineer
Indianapolis, IN · On-site
$92K - $139K/yr
Ensures the site's compliance with internal GMP's, CSV and external regulatory requirements. At ... maintenance contracts and changes. • Responsible for the support and execution of automation ...
Automation Engineer
Indianapolis, IN · On-site
$92K - $139K/yr
Ensures the site's compliance with internal GMP's, CSV and external regulatory requirements. At ... maintenance contracts and changes. • Responsible for the support and execution of automation ...
Senior Automation Engineer
Indianapolis, IN · On-site
$124K - $186K/yr
Ensures the site's compliance with internal GMP's, CSV and external regulatory requirements. At ... contracts and changes. • Responsible for the management, support and execution of automation ...
Senior Automation Engineer
Indianapolis, IN · On-site
$124K - $186K/yr
Ensures the site's compliance with internal GMP's, CSV and external regulatory requirements. At ... contracts and changes. • Responsible for the management, support and execution of automation ...
Site Equipment & CQV Lead
$124K - $186K/yr
Manage team of CQV/CSV and Equipment Engineers to maintain equipment reliability and ensuring ... Contracts and manages outside vendors and contractors to fulfill business needs. * Authors and/or ...
Site Equipment & CQV Lead
$124K - $186K/yr
Manage team of CQV/CSV and Equipment Engineers to maintain equipment reliability and ensuring ... Contracts and manages outside vendors and contractors to fulfill business needs. * Authors and/or ...
... CSV) and Power BI‐style dashboards depending on maturity and use case. • Identify trends ... in a contract role with minimal direction. Preferred : • Exposure to reliability, asset ...
... CSV) and Power BI‐style dashboards depending on maturity and use case. • Identify trends ... in a contract role with minimal direction. Preferred : • Exposure to reliability, asset ...
... internal/contract resources, scheduling, and issue resolution * Identify and implement process ... Knowledge of computer system validation (CSV) and change control practices * Experience supporting ...
... internal/contract resources, scheduling, and issue resolution * Identify and implement process ... Knowledge of computer system validation (CSV) and change control practices * Experience supporting ...
Process Automation Engineer
Clinton, IN · On-site
... internal/contract resources, scheduling, and issue resolution * Identify and implement process ... Knowledge of computer system validation (CSV) and change control practices * Experience supporting ...
Process Automation Engineer
Clinton, IN · On-site
... internal/contract resources, scheduling, and issue resolution * Identify and implement process ... Knowledge of computer system validation (CSV) and change control practices * Experience supporting ...
Contract Duration: 12 Months Key Responsibilities: * Collaborate with site teams, Data Integrity ... Bachelor's degree in Engineering * 8+ years of data management experience in the pharmaceutical ...
Quick apply
Contract Duration: 12 Months Key Responsibilities: * Collaborate with site teams, Data Integrity ... Bachelor's degree in Engineering * 8+ years of data management experience in the pharmaceutical ...
Pharmaceutical Project Manager
Indianapolis, IN · On-site
$90.50 - $135/hr
The Project Manager reports to the Project Executive and partners with Engineering, QA/Validation ... Manage and appropriately document change orders, project delays, procurement, and contract ...
Pharmaceutical Project Manager
Indianapolis, IN · On-site
$90.50 - $135/hr
The Project Manager reports to the Project Executive and partners with Engineering, QA/Validation ... Manage and appropriately document change orders, project delays, procurement, and contract ...
Associate Director of Enterprise Systems
Fishers, IN · On-site
$100K - $124K/yr
... Contract Development and Manufacturing Organization (CDMO) . This role has end-to-end ... Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain ...
Associate Director of Enterprise Systems
Fishers, IN · On-site
$100K - $124K/yr
... Contract Development and Manufacturing Organization (CDMO) . This role has end-to-end ... Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain ...
Associate Director of Enterprise Systems
Fishers, IN · On-site
$96K - $119K/yr
... Contract Development and Manufacturing Organization (CDMO) . This role has end‑to‑end ... Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain ...
Associate Director of Enterprise Systems
Fishers, IN · On-site
$96K - $119K/yr
... Contract Development and Manufacturing Organization (CDMO) . This role has end‑to‑end ... Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain ...
Associate Director of Enterprise Systems
$96K - $119K/yr
... Contract Development and Manufacturing Organization (CDMO) . This role has end‑to‑end ... Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain ...
Quick apply
Associate Director of Enterprise Systems
$96K - $119K/yr
... Contract Development and Manufacturing Organization (CDMO) . This role has end‑to‑end ... Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain ...
Associate Director of Enterprise Systems
Fishers, IN · On-site
$100K - $124K/yr
... Contract Development and Manufacturing Organization (CDMO) . This role has endtoend accountability ... Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain ...
Associate Director of Enterprise Systems
Fishers, IN · On-site
$100K - $124K/yr
... Contract Development and Manufacturing Organization (CDMO) . This role has endtoend accountability ... Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain ...
Sr. Associate-Global Lab Informatics (LIMS)
Indianapolis, IN · On-site
$70 - $90/hr
This is a **Fixed Duration position (anticipated 3-year contract)** where you will provide ... Bachelor's degree in Chemistry, Biology, Engineering, Information Technology, or a related ...
Sr. Associate-Global Lab Informatics (LIMS)
Indianapolis, IN · On-site
$70 - $90/hr
This is a **Fixed Duration position (anticipated 3-year contract)** where you will provide ... Bachelor's degree in Chemistry, Biology, Engineering, Information Technology, or a related ...
Contract Csv Engineer information
What is a contract CSV engineer?
Contract CSV Engineers are professionals hired on a contract basis to oversee Computer System Validation (CSV) processes within organizations, particularly in regulated industries like pharmaceuticals and biotechnology. They ensure that computer systems used for processes such as manufacturing, laboratory analysis, and data management comply with regulatory standards (like FDA 21 CFR Part 11). Their responsibilities include developing validation protocols, performing risk assessments, executing testing, and documenting results to ensure data integrity and system reliability. Contract positions allow companies to access specialized expertise for specific projects or during peak workloads without a long-term employment commitment.
What are the key skills and qualifications needed to thrive as a contract CSV engineer?
To thrive as a Contract CSV (Computer System Validation) Engineer, you need a solid background in computer science or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience in validation processes. Familiarity with validation lifecycle documentation, risk management tools, and software like TrackWise or Veeva Vault is typically required. Strong analytical thinking, attention to detail, and effective communication skills help in managing projects and collaborating with cross-functional teams. These competencies ensure compliance, system integrity, and successful project delivery in regulated industries such as pharmaceuticals and biotechnology.
What are some common challenges contract CSV engineers face when joining new projects, and how can they adapt quickly?
Contract CSV Engineers often step into projects at various stages, which can pose challenges such as understanding existing validation documentation, aligning with specific company SOPs, and quickly adapting to unique project timelines. To adapt effectively, it's important to proactively communicate with project managers and team members, thoroughly review current validation protocols, and clarify expectations early on. Familiarizing oneself with the company’s preferred validation tools and systems also helps ensure a smoother transition and fosters effective collaboration.
What is the difference between Contract Csv Engineer vs Data Analyst?
| Aspect | Contract Csv Engineer | Data Analyst |
|---|---|---|
| Required Credentials | Typically requires a degree in computer science, engineering, or related field; proficiency in CSV processing tools and scripting languages | Usually requires a degree in statistics, mathematics, or related field; skills in data visualization and analysis tools |
| Work Environment | Often project-based, working with data pipelines, ETL processes, and database management | Primarily office-based, analyzing data sets, creating reports, and providing insights |
| Employer & Industry Usage | Used by tech companies, data firms, and organizations needing data pipeline support | Common in finance, marketing, healthcare, and consulting industries |
The Contract Csv Engineer focuses on building and maintaining CSV data pipelines and tools, often in a technical environment, while the Data Analyst interprets data to generate insights and reports. Both roles require strong data skills but differ in their primary functions and work settings.
What are the most commonly searched types of Csv Engineer jobs in Indiana?
The most popular types of Csv Engineer jobs in Indiana are:
What are popular job titles related to Contract Csv Engineer jobs in Indiana?
For Contract Csv Engineer jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Contract Csv Engineer jobs in Indiana look for?
The top searched job categories for Contract Csv Engineer jobs in Indiana are:
What cities in Indiana are hiring for Contract Csv Engineer jobs?
Cities in Indiana with the most Contract Csv Engineer job openings:
Contractor
Re-posted 3 days ago
Job description
Job Title: Validation Engineer
Location: Indianapolis / Bloomington, IN (100% Onsite)
Duration: Long term Contract
Interview Mode: Onsite (Local candidates preferred)
Job Summary:
We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation activities, documentation migration, and equipment qualification to ensure compliance with regulatory standards.
Key Responsibilities
- Lead migration of legacy validation documents into the Kneat digital platform, ensuring accuracy and compliance
- Perform equipment qualification for lab instruments (pH meters, thermal mixers, peristaltic pumps, nutating mixers, etc.)
- Execute temperature mapping studies, including work with Ellab systems or similar equipment
- Support Computer Systems Validation (CSV) activities and documentation
- Assist Process Engineering teams to ensure project timelines and milestones are met
- Ensure all validation activities comply with GMP and regulatory requirements
- Maintain clear, accurate, and compliant documentation
Required Qualifications:
- Bachelor’s degree in Engineering, Science, or related field
- 6+ years of experience in Computer Systems Validation (CSV)
- 4+ years of experience in pharmaceutical manufacturing environment
- Hands-on experience with equipment qualification and validation
- Strong knowledge of CSV principles and regulatory compliance
- Experience working in onsite, fast-paced environments