Computer System Validation Engineer

Katalyst Healthcares and Life Sciences

Princeton, NJ

Job Description:

In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.

Responsibilities:

pply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
Facilitate risk assessments to identify validation deliverables and project requirements.
Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
nalyze validation data and troubleshoot issues in collaboration with technical teams.
Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Requirements:

Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
Hands-on experience in validating computerized systems.
Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
bility to work effectively in a dynamic, cross-functional team environment.
Proven expertise in applying data governance measures and creating impactful data visualizations.
Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the Computer System Validation Engineer in Princeton, NJ vacancy

Validation Engineer
$114.55k
...SATHRAM CORPORATION has openings for the position Validation Engineer with Master’s degree in Computer Science, Engineering any, Technology, Cybersecurity,... ...Analysis, Remediation Plan and maintenance of hybrid systems, close and open record systems in cleaning validation...
Computer
Full time
Shift work
Day shift
Sathram Corp
Plainsboro, NJ
15 hours ago
Systems Engineer
$100k - $160k
...(IDA) in Princeton, NJ has an immediate career opening for a Systems Engineer with expertise in the Linux operating system. Experience with... ...technologies; keeps abreast of industry trends. # Communicates all computer network, system and service problems and outages immediately...
Computer
Immediate start
Institute for Defense Analyses
Princeton, NJ
3 days ago
Systems Engineer
...cycle for developing high quality software system. Perform System Scope identification,... ...analysis, data mapping, and data validation to assist the development of coding specifications... .... Requirements Bachelor’s Degree in Computer Science or a closely related field. #J-...
Computer
Full time
Sumas Corporation Inc
Plainsboro, NJ
3 days ago
Lead Systems Engineer
$121k - $194k
...Defense Analyses (IDA) has an immediate career opening for a Lead Systems Engineer. This opening is located at IDA's Center for Communications... ...a qualified individual to manage its High Performance Computing (HPC) resources, including compute clusters, parallel file systems...
Computer
Immediate start
Institute for Defense Analyses
Princeton, NJ
3 days ago
Validation Specialist
...878Reference26-01830Summary :This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically... ...and testing.Required Qualifications:Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related...
Computer
Katalyst Healthcares & Life Sciences
Lawrenceville, NJ
9 days ago
Systems Engineer
...R3 Technology Inc. seeks Systems Engineer for it Hillsborough NJ office. Architect, design and build scalable infrastructure and platforms... ...sites within the United States. Must have Master's degree in Computer Science, Information Systems, Electrical Engineering or related...
Computer
Work at office
Relocation
R3tek
Hillsborough, NJ
3 days ago
Systems Engineer, Logistic Systems
$115k - $125k
...Teamwork! Job Description The Systems Engineer, based in Somerset, NJ, is a... ...feasibility studies, and performing testing and validation. Collaboration: Collaborate with... ...verbal communication skills. ~ High computer literacy in MS Office Suite. ~...
Computer
Full time
Local area
Flexible hours
BEUMER Group
Somerset, NJ
14 days ago
Sr. Systems Engineer
$110k - $120k
...Design, deploy, and support core systems for Corporate and MyMedlogix SaaS... ...controls and updates, ensuring each is validated through thorough testing, peer... ...Required: BS/MS degree in Computer Science, Information Security, Engineering, or equivalent professional experience...
Computer
Permanent employment
Temporary work
For contractors
Work experience placement
Local area
Remote work
Jobs via Dice
Ewing, NJ
15 hours ago
Cloud Site Reliability Engineer (SRE) - Data Management & Analytics Platform
$160k - $240k
Cloud Site Reliability Engineer (SRE) - Data Management & Analytics Platform Location... ...clients use Bloomberg products, how our systems perform, and how employees interact with... ...distributed systems.A Bachelor’s degree in Computer Science, Engineering, Mathematics, or a...
Computer
Temporary work
For contractors
Work experience placement
Bloomberg
Princeton, NJ
19 days ago
Validation Engineer
...Title: Validation Engineer 10 Openings Location: FL Onsite Job Description 5 to 10 years' Experience 100% Medical domain, medical implants IQ, OQ PQ , equipment qualification, process qualification in medical device manufacturing...
Kasmo Global
Princeton, NJ
2 days ago
Senior Validation Engineer
$87.1k - $94.6k
...Execution & Safety Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety Deliver C&Q... ...and Experience ~ Bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute...
For contractors
Worldwide
CAI
Princeton, NJ
4 days ago
Validation Engineer
.../GC NON-NEGOTIABLE ~ Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry). ~4 to 7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical...
Remote work
3B Staffing LLC
Plainsboro, NJ
15 hours ago
Validation Engineer
$72.8k - $80.1k
...Direct small teams in document development and/or execution Qualifications and Experience - Bachelor's degree in a science or engineering field (or equivalent experience) - 2–4 years' experience in commissioning and qualification in a regulated industry -...
Worldwide
CAI
Princeton, NJ
3 days ago
validation Engineer
...will be responsible for day-to-day tasks related to system start up, commissioning, qualification, and validation. They will work towards ensuring compliance and... ...and PQ. Qualifications: Experience in Engineering, Commissioning, Qualification, and Validation processes...
Full time
Kasmo Global
Princeton, NJ
15 hours ago
Senior Validation Manager
...Description Job Description The Senior Validation Manager is leading the site validation... ...equipment, laboratory instrument, computer system, cleaning, and manufacturing processes... ...and in collaboration with the engineering and Quality teams. Manage multiple...
Computer
Catapult
Princeton, NJ
a month ago
Senior Site Reliability Engineer
$121.4k - $218.6k
...you have a passion for automation and building systems that scale? Join our highly skilled Site Reliability Engineering team! Our team designs, develops, and... ...autoscaling configuration, and workload scheduling for compute infrastructure Investigating and analyzing...
Computer
Work experience placement
Work at office
Akamai
Trenton, NJ
4 days ago
Site Reliability Engineer
$75.7k - $136.3k
...you have a passion for automation and building systems that scale? Join our highly skilled Site Reliability Engineering team! Our team designs, develops, and... ...relevant experience and a Bachelor's degree in Computer Engineering, Computer Science or equivalent...
Computer
Work experience placement
Work at office
Akamai
Trenton, NJ
4 days ago
Distribution Engineer
$59.15k - $106.93k
...business. Leidos is seeking Distribution Engineers & Designers in New Jersey who are passionate... ...overhead and underground distribution systems for Leidos electric utility customers Review... ...work packages Candidates should possess valid U.S. driver's license, as some local or...
Work at office
Local area
Immediate start
Remote work
Flexible hours
Leidos
Princeton, NJ
3 days ago
Principal Site Reliability Engineer
$169.3k - $304.7k
...and infrastructure that support Akamai's Compute products and services. We specialize in... ...platform. As a Principal Site Reliability Engineer - Network, you will be responsible for:... ...working with large-scale distributed systems Have a deep understanding of TCP/IP,...
Computer
Work experience placement
Work at office
Akamai
Trenton, NJ
1 day ago
Lead Site Reliability Engineer
$105.79k - $141.05k
...to drive technical direction and resolve systemic issues across a broad range of network... ...you'll coordinate across architecture, engineering, and systems development organizations to... ...’s degree or equivalent in engineering, computer science, or related field. ~8+ years in...
Computer
Temporary work
Remote work
Lumen Inc
Trenton, NJ
15 hours ago
IT Validation Specialist
$68.05k - $89.31k
...Legend Biotech is seeking an IT Validation Analyst as part of the R&D Systems team based in Somerset, NJ.... ...Responsibilities Execute and support Computer System Validation (CSV) and... ...’s Degree in a Life Science, IT, Engineering or a related field ~1-3 years...
Computer
Permanent employment
Full time
Temporary work
For contractors
Local area
Worldwide
Flexible hours
Legend Biotech USA, Inc.
Somerset, NJ
a month ago
Validation Engineer
...R3 Technology Inc. seeks Validation Engineer or it Hillsborough NJ office to gather requirements to develop product-level requirements and assist with high level systems view of product design. Conduct multi-disciplined product and process performance testing for both...
Work at office
Relocation
R3tek
Hillsborough, NJ
3 days ago
Programmer/Systems Analyst
$78k - $85k
...Job Description Job Description Programmer / Systems Analyst ???? Location: Somerset, NJ ???? Job Type: Full-Time, On-site... ...Automate Microsoft Excel Education: Bachelor’s degree in Computer Science, Information Technology, or a related field, plus 5 years...
Computer
Full time
Work at office
Remote work
Monday to Friday
Budd Van Lines
Somerset, NJ
13 days ago
Senior Engineer, IT - GxP Infrastructure & Systems
$100k - $133k
...Pharmaceuticals is seeking a motivated Senior Engineer, IT - GxP Infrastructure & Systems to support and maintain the... ...testing, and disaster recovery validation. Configure, maintain, and... ...QualificationsBachelor’s degree in IT, Computer Science, Engineering, or a related...
Computer
Full time
Temporary work
Work at office
Local area
Shift work
Rocket Pharmaceuticals
Cranbury, NJ
a month ago
Teller
$16 - $22.56 per hour
...exceptional customer service as expected in the Customer Insight surveys, scored by Avannis. Applies a combination of knowledge of the computer systems, service skills, product knowledge and knowledge of policies and procedures to successfully execute operational excellence...
Computer
For contractors
Work at office
Monday to Friday
Night shift
S&T Bancorp
West Windsor, NJ
3 days ago
Project Engineer III - Energy
...the Energy Transition. We provide turnkey engineering and construction services designed to... ...project’s energy savings guarantee. Validate the Energy Savings Guarantee and M&V Plan... ...Skills and Abilities ~ Proficiency in computer applications, preferably Microsoft Office...
Computer
Full time
Contract work
Temporary work
For contractors
For subcontractor
Start working today
Work at office
VeregyLLC
Lawrence Township, NJ
26 days ago
Receiver Part Time 13-29
...standards. Essential Responsibilities and Duties: Unload deliveries and verify invoices Ability to perform data entry in a computer and extract information on orders and/or purchase orders. Ready receiving documents in an organized way for delivery to HQ...
Computer
Part time
McCaffrey's Food Markets
Princeton Junction, NJ
2 days ago
Process Engineer I
$62.1k - $85.1k
...SUMMARY DESCRIPTION The Process Engineer I is responsible to understand,... ...studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements... ...relevant experience. TOOLS & SYSTEMS General office equipment: Computers, printers, copiers, fax machines,...
Computer
Temporary work
Work at office
Immediate start
Integra LifeSciences
Plainsboro, NJ
3 days ago
Process Engineer II
$71.3k - $97.75k
...standards of care. The Process Engineer is responsible to understand... ...studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements... ...General office equipment: Computers, printers, copiers, fax... ...and telephone communication systems. Software and systems: ERP...
Computer
Contract work
Temporary work
Immediate start
Integra LifeSciences
Plainsboro, NJ
3 days ago
Customer Service Specialist
$30 - $36 per hour
...availability during specific hours and the ability to work with complex computer applications.Responsibilities include:Handle inquiries... ...or confirm sales as needed.Navigate a computerized data entry system and other relevant applications.Document customer needs in databases...
Computer
Temporary work
Collabera
Princeton, NJ
3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Computer System Validation Engineer. Be the first to apply!