Execute Computer System Validation activities for Electronic Batch Record (EBR) systems supporting aseptic fill operations in compliance with cGMP, 21 CFR Part 11, and EU Annex 11 * Support ...
Execute Computer System Validation activities for Electronic Batch Record (EBR) systems supporting aseptic fill operations in compliance with cGMP, 21 CFR Part 11, and EU Annex 11 * Support ...
5910 - CSV Engineer / Validation Engineer
Kalamazoo, MI · On-site +1
$65K - $90K/yr
We constantly acquire new skills and learn from our experiences to enhance our collective expertise Validation Engineer Responsibilities: * Execute Computer System Validation activities for ...
Quick apply
5910 - CSV Engineer / Validation Engineer
Kalamazoo, MI · On-site +1
$65K - $90K/yr
We constantly acquire new skills and learn from our experiences to enhance our collective expertise Validation Engineer Responsibilities: * Execute Computer System Validation activities for ...
5910 - CSV Engineer / Validation Engineer
Kalamazoo, MI · On-site
$65K - $90K/yr
We constantly acquire new skills and learn from our experiences to enhance our collective expertise Validation Engineer Responsibilities: * Execute Computer System Validation activities for ...
5910 - CSV Engineer / Validation Engineer
Kalamazoo, MI · On-site
$65K - $90K/yr
We constantly acquire new skills and learn from our experiences to enhance our collective expertise Validation Engineer Responsibilities: * Execute Computer System Validation activities for ...
Contract Required Skills & Qualification The System Integrator (SI) role is for home appliance ... Candidate Profile System Integration, Product validation and verification, Project management ...
Quick apply
Contract Required Skills & Qualification The System Integrator (SI) role is for home appliance ... Candidate Profile System Integration, Product validation and verification, Project management ...
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From Home Computer System Validation information
See Decatur, MI salary details
$9.76 - $16.09
2% of jobs
$16.09 - $22.43
9% of jobs
$22.43 - $28.76
1% of jobs
$28.76 - $35.09
4% of jobs
$38.93 is the 25th percentile. Wages below this are outliers.
$35.09 - $41.42
15% of jobs
$41.42 - $47.75
9% of jobs
The median wage is $53.03 / hr.
$47.75 - $54.09
13% of jobs
$59.13 is the 75th percentile. Wages above this are outliers.
$54.09 - $60.42
29% of jobs
$60.42 - $66.75
12% of jobs
$66.75 - $73.08
2% of jobs
$73.08 - $79.42
5% of jobs
$9
$50
$79
How much do from home computer system validation jobs pay per hour?
What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?
| Aspect | From Home Computer System Validation | From Home Quality Assurance Specialist |
|---|---|---|
| Certifications | GxP validation, 21 CFR Part 11 | ISO 9001, QA certifications |
| Work Environment | Primarily remote, focused on system testing and validation | Remote or onsite, focused on process audits and compliance |
| Industry Usage | Pharmaceutical, biotech, healthcare | Manufacturing, software, healthcare |
| Job Focus | Ensuring computer systems meet regulatory standards | Ensuring overall quality processes and compliance |
From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.
Other
Posted 25 days ago
Job description
Validation Engineer Responsibilities:
- Execute Computer System Validation activities for Electronic Batch Record (EBR) systems supporting aseptic fill operations in compliance with cGMP, 21 CFR Part 11, and EU Annex 11
- Support development and review of validation deliverables including URS, FDS, risk assessments, and validation plans in alignment with GAMP 5 principles
- Collaborate with Operations, Quality, Engineering, IT, and Automation teams to define system requirements, intended use, and validation scope
- Participate in execution and documentation of validation testing (IQ, OQ, PQ), including deviation tracking and resolution support
- Support validation of interfaces between PLC/SCADA systems and MES/EBR platforms to ensure data integrity and accurate batch execution
- Maintain organized, inspection-ready validation documentation and support change control and periodic review activities for validated EBR systems
Requirements:
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical field
- 3+ years of hands-on Computer System Validation (CSV) experience in a regulated pharmaceutical or biotechnology environment, supporting MES and/or Electronic Batch Record (EBR) systems
- Working knowledge of cGMP regulations, including 21 CFR Part 11 and EU Annex 11, and application of GAMP 5 principles across the system lifecycle
- Experience supporting validation documentation and testing activities (URS, FDS, risk assessments, IQ/OQ/PQ) and managing deviations and change controls
- Ability to collaborate effectively with cross-functional teams (Operations, Quality, Engineering, IT, Automation) and support system interfaces with PLC/SCADA-controlled equipment
- Ability to travel/be on-site up to 25% of the time in Kalamazoo, MI. This role can be 75% remote.
About Verista
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Fishers, IN, US
Year founded
2020