Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review * Execute risk assessments and data integrity assessments aligned with ALCOA ...
Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review * Execute risk assessments and data integrity assessments aligned with ALCOA ...
Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review * Execute risk assessments and data integrity assessments aligned with ALCOA ...
Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review * Execute risk assessments and data integrity assessments aligned with ALCOA ...
... Computer System Validation- Life Sciences We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates ...
... Computer System Validation- Life Sciences We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates ...
Sr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible ... Generate or review/update computer system related policies, procedures, templates, forms, etc.
Quick apply
Sr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible ... Generate or review/update computer system related policies, procedures, templates, forms, etc.
System Test and Validation Lead
New York, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
New York, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jersey City, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jersey City, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jericho, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jericho, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Stamford, CT · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Stamford, CT · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Stamford, CT · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Stamford, CT · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jersey City, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jersey City, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Morristown, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Morristown, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
New York, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
New York, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Morristown, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Morristown, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Morristown, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Morristown, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jericho, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jericho, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jersey City, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jersey City, NJ · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jericho, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Jericho, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Stamford, CT · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
Stamford, CT · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
New York, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
System Test and Validation Lead
New York, NY · On-site +1
... from complexity and accelerate their path to value creation. Qualifications Required ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...
Validation Engineer II
East Windsor, NJ · On-site
Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and ... Every interaction with our patients, providers, employees, and other stakeholders comes from a ...
Validation Engineer II
East Windsor, NJ · On-site
Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and ... Every interaction with our patients, providers, employees, and other stakeholders comes from a ...
From Home Computer System Validation information
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.
What are the most commonly searched types of Computer System Validation jobs in New York? The most popular types of Computer System Validation jobs in New York are:
What are popular job titles related to From Home Computer System Validation jobs in New York? For From Home Computer System Validation jobs in New York, the most frequently searched job titles are:
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Full-time
Posted 24 days ago
Job description
Job Type
Full-time
Description
Position Type: Full-time Employee (FTE)
Location: Piscataway, NJ (onsite - physical presence required)
Reports To: Sr. Director of IT
Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future
Position Summary
We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
Essential Duties & Responsibilities
Requirements
Position Requirements and Qualifications
Experience:
Specialized Knowledge and Skills:
Work Environment & Physical Demands:
Noise:
Standing/Lifting:
Visual:
Stress:
Travel:
Full-time
Description
Position Type: Full-time Employee (FTE)
Location: Piscataway, NJ (onsite - physical presence required)
Reports To: Sr. Director of IT
Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future
Position Summary
We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
Essential Duties & Responsibilities
- Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems
- Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM
- Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review
- Execute risk assessments and data integrity assessments aligned with ALCOA+ principles
- Support audits, inspections, CAPA investigations, and deviations related to computerized systems
- Collaborating with senior validation leads and SMEs to drive consistent practices across sites
Requirements
Position Requirements and Qualifications
- Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment
- Minimum 5 years of CSV experience in a GxP-regulated environment
- Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)
Experience:
- Minimum 5 years of CSV experience in a GxP-regulated environment
- Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)
Specialized Knowledge and Skills:
- Familiarity with GAMP 5 principles and risk-based validation
- Exposure to Caliber LIMS
- Exposure to SAP (QM, MM, PP) in a GxP context
- Experience with BMRAM or equivalent CMMS/calibration systems
- Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams
Work Environment & Physical Demands:
- This is an on-site position
- Must be able to work extended hours or weekend hours, as may be required.
Noise:
- No extraordinary noise levels.
Standing/Lifting:
- Very unlikely, but can be able to lift at least 20 lbs.
Visual:
- No extraordinary requirements.
Stress:
- High-paced demanding environment to meet ambitious project goals.
Travel:
- Moderate domestic travel may be required.
About Kashiv BioSciences
Sourced by ZipRecruiter
Industry
Manufacturing
Company size
201 - 500 Employees
Headquarters location
Piscataway, NJ, US
Year founded
2011