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Senior CSV Consultant
@Valspec
[Hiring] Senior CSV Consultant @Valspec
Mar 24, 2025 - Valspec is hiring a remote Senior CSV Consultant. 💸 Salary: unspecified. 📍Location: USA.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
This role involves supporting our client globally as a Computer System Validation Engineer. The ideal candidate will have experience in the validation of computer systems within biopharmaceutical environments.
- Validate enterprise computer systems
- Work with global representatives from the company in Ohio, New Jersey, California, and Europe, remotely
- Part-time, 6 months+
- Expertise in SDLC documentation, testing, data compliance, qualification, and validation of computer systems
-
Systems include:
- Microsoft Active Directory (Windows Server 2016/2019) hosted in AWS Cloud on EC2 Windows Servers
- Microsoft Endpoint Configuration Manager Current Branch (version 2203) hosted in AWS Cloud on EC2 Windows Servers & SQL Server
- McAfee ePolicy Orchestrator (ePO – version 5.3 and 5.10) hosted in AWS Cloud on EC2 Windows Servers, AWS RDS & S3 buckets
- IPSEC tunnel – technical configuration for communication between the AWS Cloud and the shop floor network in the MMD sites
- Collaborate across functions (e.g. quality, IT, and vendors)
- Assist lead validation engineers and the head of validation in developing practical solutions to problems
- Execute validation activities: method validation, equipment qualification, computer system validation, and method transfer
- Coordinate and execute commissioning and qualification of equipment and computer systems for regulated and non-regulated operations
Responsibilities
- Development and execution of qualification and validation documentation according to GAMP 5 guidance for Computer Systems
-
Documentation includes, but is not limited to:
- Risk Assessments
- Validation Plans
- Design Specifications
- User Requirements
- Functional Requirements
- IQ/OQ/PQ Protocols
- Requirements Traceability Matrices
- Summary Reports
- Validation of computer systems, such as servers, network devices, and related peripherals
-
Creation of new and updates to existing IT documentation, including:
- OT Baseline
- OT Identity Management for Shop Floor Network
- OT Security Baseline
- OT Security Supplementary Guidance
-
Development of SDLC documentation, including:
- Quality Assurance Plan (QAP)
- IT Risk Assessments
- Requirements Specification
- Configuration Specifications
- Test Protocols/UAT
- Requirements Traceability Matrix (RTM)
- Disaster Recovery Plan
- Quality Assurance Summary Report (QASR)
- SOPs and Work instructions
Skills and Experience
- Experience qualifying computer systems within a life sciences environment
- Solid knowledge of qualification/validation principles and their practical applications
- Direct experience developing and executing validation protocols
- Tactical thinker with experience working with customers developing testing, validation and/or quality strategies
- A team player with excellent verbal, written and interpersonal communication skills
Benefits
- Premium medical
- 401K match
- Profit sharing
- Tuition reimbursement
- Other unique incentives
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
QA
QA
|
Salary
💸
unspecified
|
Remote
Location
USA
|
|
Job Type
contract
|
Posted
Mar 24, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
