Automation Validation Lead
Andover, MA · On-site +1
Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...
Andover, MA · On-site +1
Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...
Andover, MA · On-site +1
Automation Validation Lead Location : Andover, MA Duration - 6 months (possible extension ... Ethernet Profibus OPC The ideal candidate should be familiar with the following computer system ...
Computer System Validation & Assurance. Lead the company's IT contribution to computer system validation and assurance under GAMP 5 Second Edition and the FDA's Computer Software Assurance (CSA ...
Computer System Validation & Assurance. Lead the company's IT contribution to computer system validation and assurance under GAMP 5 Second Edition and the FDA's Computer Software Assurance (CSA ...
Computer System Validation & Assurance. Lead the company's IT contribution to computer system validation and assurance under GAMP 5 Second Edition and the FDA's Computer Software Assurance (CSA ...
Computer System Validation & Assurance. Lead the company's IT contribution to computer system validation and assurance under GAMP 5 Second Edition and the FDA's Computer Software Assurance (CSA ...
$140K - $165K/yr
Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...
$140K - $165K/yr
Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...
Lexington, MA · On-site
$96K - $130K/yr
Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...
Lexington, MA · On-site
$96K - $130K/yr
Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Boston, MA · On-site
Extensive experience with pharma companies, including strong CSV (Computer System Validation) skills * Capable of executing both GxP and non-GxP programs/projects * Excellent communication skills ...
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Boston, MA · On-site
Extensive experience with pharma companies, including strong CSV (Computer System Validation) skills * Capable of executing both GxP and non-GxP programs/projects * Excellent communication skills ...
Ensures impact to validation status for new systems and changes to existing systems are performed through science-based quality risk assessments. * Collaborate with Quality Assurance to ensure all ...
Ensures impact to validation status for new systems and changes to existing systems are performed through science-based quality risk assessments. * Collaborate with Quality Assurance to ensure all ...
$96K - $130K/yr
Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...
Quick apply
$96K - $130K/yr
Install and upgrade computer components and software, manage virtual servers, and integrate automation processes per Computer System Validation SOPs and protocols * Ensure that the IT environment is ...
Lead and execute Computer System Validation (CSV) activities (URS, FRS, IQ/OQ/PQ, etc.). * Author and maintain validation and compliance documentation. * Act as system administrator for QC lab ...
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Lead and execute Computer System Validation (CSV) activities (URS, FRS, IQ/OQ/PQ, etc.). * Author and maintain validation and compliance documentation. * Act as system administrator for QC lab ...
Lexington, MA · On-site
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Lexington, MA · On-site
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Lexington, MA · On-site
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Quick apply
Lexington, MA · On-site
$110K - $150K/yr
Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. * Lead implementation of change management of QC instruments, software upgrades, and new ...
Boston, MA · On-site +1
Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands-on equipment start-up and troubleshooting experience is highly desired. * Report writing experience ...
Boston, MA · On-site +1
Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation. * Hands-on equipment start-up and troubleshooting experience is highly desired. * Report writing experience ...
SUMMARY The Senior Manager, QA Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems ensuring they are implemented ...
SUMMARY The Senior Manager, QA Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems ensuring they are implemented ...
Support computer system validation activities through the drafting, execution, and maintenance of qualification scripts, protocols, and associated validation documentation. * Work independently and ...
Support computer system validation activities through the drafting, execution, and maintenance of qualification scripts, protocols, and associated validation documentation. * Work independently and ...
Support computer system validation activities through the drafting, execution, and maintenance of qualification scripts, protocols, and associated validation documentation. * Work independently and ...
Support computer system validation activities through the drafting, execution, and maintenance of qualification scripts, protocols, and associated validation documentation. * Work independently and ...
Bedford, MA · On-site
$150K/yr
Support Computer System Validation (CSV) documentation (URS/NFR/FS/DS/IQ/OQ/PQ). Define patch management and vulnerability handling processes for validated OT systems. Support audit readiness and ...
Bedford, MA · On-site
$150K/yr
Support Computer System Validation (CSV) documentation (URS/NFR/FS/DS/IQ/OQ/PQ). Define patch management and vulnerability handling processes for validated OT systems. Support audit readiness and ...
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Valspec--a global provider of system validation and lifecycle services--provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999 ...
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Valspec--a global provider of system validation and lifecycle services--provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999 ...
Cambridge, MA · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
Cambridge, MA · On-site
$55K - $58K/yr
We specialize in the following technologies- QA/Software Testing, Business Analysis and Computer System Validation. RELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON, VA Title ...
$11.49 - $18.94
2% of jobs
$18.94 - $26.40
9% of jobs
$26.40 - $33.85
1% of jobs
$33.85 - $41.30
4% of jobs
$45.83 is the 25th percentile. Wages below this are outliers.
$41.30 - $48.76
15% of jobs
$48.76 - $56.21
9% of jobs
The median wage is $62.42 / hr.
$56.21 - $63.67
13% of jobs
$69.60 is the 75th percentile. Wages above this are outliers.
$63.67 - $71.12
29% of jobs
$71.12 - $78.57
12% of jobs
$78.57 - $86.03
2% of jobs
$86.03 - $93.48
5% of jobs
$11
$59
$93
Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.
To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.
Emvia Inc
Position : Automation Validation Lead
Location : Andover, MA
Duration - 6 months (possible extension)
Interview mode- Local or regional candidates preferred. May be open to Skype for excellent candidate.
Job description:
The Automation Validation Lead is responsible for overseeing all automation testing (leveraged software Factory Acceptance Tests, Commissioning and Validation) to ensure successful validation of all automation systems
The Automation Validation Lead will report to the Automation Lead and additionally take direction from the Projects Validation Lead. The Automation Validation Lead will be an active member of the overall project team working with the team, Engineer of Record and Construction Manager.
Key Responsibilities:
Finalize the Automation Validation Plan
Work with a team of Engineers and System Integration (SI) contractors to complete all validation deliverables related to the Delta-V Manufacturing Control System (MCS) and Qualified Utilities Network (QUN)
Give guidance on validation best practices for automation hardware, software and computer systems.
Follow FDA Title 21 CFR Part 11 for Data Integrity Compliance
Draft, review or approve automation design and testing documents for all phases of testing (sFAT, Commissioning, Validation)
Drive deviation resolution for all testing
Requirements:
7 years of relevant automation validation experience
The candidate must have a strong background working in cGMP environments.
The candidate must have excellent communication skills.
Experience with Emerson Controllers and Emerson DeltaV Software is required.
The ideal candidate would have experience with the following hardware: Allen Bradley PLCs and I/O
o The ideal candidate would have experience with the following software: GEs Proficy FIX, OSISofts OSIPi or similar Historian software Reporting software, InfoBatch is preferred
The ideal candidate should be familiar with the following communication methods/protocols: Ethernet Profibus OPC
The ideal candidate should be familiar with the following computer system software and hardware: Windows operating systems Windows Terminal Services/Remote Desktop VMWare Dell VRTX familiarity is a plus
Limited local travel to software Factory Acceptance Tests (FATs) may be required
Work Location: Andover, MA
Over time may be required during peak times but the expectation is that the it will typically be a standard 40 hour work week.
All your information will be kept confidential according to EEO guidelines.
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Software development
11 - 50 Employees
Allen, TX, US
2007