Computer System Validation Engineer

Katalyst HealthCares & Life Sciences

CSV Consultant

Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems. Strong experience in CSV processes, regulatory frameworks, validation documentation, and exposure to clinical and regulatory domains.

Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, and ITIL. Ensure audit and inspection readiness. Conduct periodic reviews, access roster reviews, and audit trail reviews. Manage deviations, CAPA processes, SOP, and policy compliance. Author and review URS / FS documents, validation protocols, validation plans & reports, and final summary reports. Perform risk-based validation and testing aligned with CSA (Computer Software Assurance). Support validation lifecycle from planning to execution and closure. Work with platforms such as Veeva Vault Suite, LabWare LIMS, SAP (GxP modules), and BIOVIA Electronic Lab Notebook. Collaborate with teams across Biostatistics, Clinical & Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, Manufacturing, Quality, and TechOps.

8–10 years of experience in Computer System Validation (CSV). Strong knowledge of GxP regulations, validation frameworks, GAMP 5, and CSA principles. Experience with CAPA, deviation management, SOP, and policy compliance. Strong documentation and validation lifecycle experience. Good understanding of life sciences domain processes.

Apply

Vacancy posted 15 hours ago

Similar jobs that could be interesting for youBased on the Computer System Validation Engineer in New Wilmington, PA vacancy

System Engineer
...Education and Experience Bachelor’s Degree in Computer Science, Information Technology, or equivalent combination of experience and... ...management, and modern cloud-based services. Experience with Cisco Call Manager or other unified communications systems is a plus....
Computer
Full time
Work at office
Robert Half
New Castle, PA
1 day ago
Engineering Technical Leader - Systems
$104.8k - $149.3k
...highly motivated and technically versatile Senior Systems Engineer to lead the architecture, integration, validation, and productization of next-generation... ...product platform that combines robotics, autonomy, computer vision, artificial intelligence, software, edge...
Computer
Work experience placement
Worldwide
Wabtec
Grove City, PA
4 days ago
Systems Engineer
...Recovery runbooks, isolated backup environment validation, code upgrades, and other maintenance... ...UCS, and more. Position Title: Server Engineer 2Business Unit: TechnologyReports to:... ...and network analysis, network operating systems, reporting and logging. Collaborates on...
Suggested
Full time
Work at office
Weekend work
Day shift
First National Bank
Hermitage, PA
3 days ago
Online Survey Taker. Earn up to $25 per survey. - Remote
$25 per hour
...decisions on services and products you use every day. What We Expect Your honest opinion Attention to details Basic computer and internet skills No experience required To Qualify: You must be 18+ years old Have a desire to work from home...
Computer
Extra income
Full time
Temporary work
Part time
Second job
Remote work
Work from home
Flexible hours
Earn Haus
Pulaski, PA
18 days ago
Shift Leader - Urgently Hiring
...honest and friendly. -Excellent customer service skills -Reliable transportation to and from work (daily) -Ability to work with computers -Ability to assist the General Manager with team building -Ability to coach and lead a team with no supervision -Ability to...
Computer
Full time
Part time
Immediate start
Shift work
Applebee's
Pulaski, PA
4 days ago
Service Advisor
...offer competitive wages and embrace a “promote within” philosophyQualifications:Clean driving recordTime management skillsCommitment to 100% customer satisfactionHave basic computer skills to include typing and Microsoft ExcelBe organized, professional and courteous...
Computer
Diehl Automotive
Grove City, PA
1 day ago
Office Clerk
...some customer service or a variety of like tasks. Performs other tasks as needed. Essential Functions : - Accurate and timely computer data entry. - Excellent communication skills whether in person or through phone calls. - Participate in office training, cross...
Computer
Full time
Work at office
Local area
Alsco Inc
New Castle, PA
a month ago
Greeter - Urgently Hiring
...will wish guests farewell and invite them to come back. Requirements: -Ability to use office equipment, input information into computer/tablet accurately and in a timely manner -Excellent customer service skills -Have interpersonal skill to deal effectively with all...
Computer
Full time
Part time
Work at office
Immediate start
Flexible hours
Shift work
Applebee's
New Wilmington, PA
15 hours ago
Remote Online Consumer Research Panelist - Data Entry Clerk Welcome
$750 per week
...research on a part time basis, depending on their availability and profile fit. Requirements: Access to a smartphone, tablet, or computer with a functional camera Reliable internet connection Ability to read instructions carefully and provide honest, detailed feedback...
Computer
Part time
Casual work
Remote work
Flexible hours
AFG
New Castle, PA
4 days ago
Pharmacy Technician
$16 - $29 per hour
...enabled health services business dedicated to making the health system work better for everyone. Join us to start Caring. Connecting.... ...medication ordersVerifies medication stock and enters data in computer to maintain inventory recordsWorks with the Pharmacist to assist...
Computer
Hourly pay
Minimum wage
Full time
Temporary work
Traineeship
Work experience placement
Local area
Monday to Friday
UMR
New Castle, PA
3 days ago
Credentialing Specialist
...maintaining provider information in online credentialing databases and system (CredentialStream, CAQH, PECOS, and NPPES) • Responsible... ...and recredentialing requirements • Strong analytic computer and software skills • Excellent interpersonal skills including...
Computer
Work experience placement
Work at office
Flexible hours
Tenor Health Foundation Sharon LLC
Sharon, PA
3 days ago
Admissions Associate
...take on new responsibilities in a fast-paced environment. Must be computer literate and proficient in Microsoft Office products. Knowledge... ...Banner Document Management and the student information system Banner and Recruit CRM. Maintain accurate and up-to-date admissions...
Computer
Part time
Work at office
Monday to Friday
Flexible hours
Early shift
RPMGlobal
New Castle, PA
2 days ago
CSV Engineer
...CSV Engineer / Validation Engineer The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21... ...validation strategies aligned with CSA (Computer Software Assurance) principles....
Computer
Katalyst HealthCares & Life Sciences
New Wilmington, PA
1 day ago
Maintenance Technician
$29.5 - $31.43 per hour
...Program, troubleshoot, and operate PLCs, DCS, and interlocking systems Perform electrical troubleshooting, maintenance, and repairs... ...troubleshooting and problem-solving skills Basic math skills and computer proficiency Must be able to read, write, and speak English...
Computer
Full time
Shift work
HiFyve
New Wilmington, PA
2 days ago
Controls Specialist
...design by providing support for process controls, electrical engineering, and related systems and equipment. This position focuses on supporting a... ...regulationsKnowledge of Microsoft Office Suite and company computer systemsFamiliarity with regulatory codes and ability to...
Computer
Temporary work
For contractors
Work at office
Dairy Farmers of America
New Wilmington, PA
2 days ago
AUTOMOTIVE PARTS COUNTERPERSON / PARTS ADVISOR
...Experience with dealership management systems is preferred Automotive inventory-control experience is helpful Strong computer and data-entry skills Strong organizational... ...Professional attitude and strong work ethic Valid driver's license and acceptable driving...
Computer
Full time
Diehl Automotive Group
Hermitage, PA
5 days ago
Wilmington Area SD - Food Service Worker
...Reliable transportation to and from work A willingness to learn and grow within your position Food service experience preferred Computer literacy preferred Excellent interpersonal and communication skills Physical Requirements May Include: Standing for long...
Computer
Local area
The Nutrition Group
New Wilmington, PA
4 days ago
Direct Care Staff
...appropriately document any incidents. Correctly completes merit system paperwork daily. Complete daily progress notes on residents.... ...Work will be reviewed by interactions with consumers/ employees, computer skills/writing content & documentation on the electronic health...
Computer
Immediate start
Shift work
Community Counseling Center of Mercer County
Mercer, PA
1 day ago
EHS Field Manager
...improvement by utilizing the DFA EHS Management System. Manage environmental and safety efforts... ...Science, or related fieldMust have a valid license to operate a passenger... ...with Microsoft Office Suite and company computer systemsAble to organize time, energy, and...
Computer
Work at office
Local area
Dairy Farmers of America
New Wilmington, PA
1 day ago
Seasonal Customer Service Representative
...Navigate, lookup and enter orders into the customer order entry system ~ Answer multiple chat queries simultaneously, while... ...Ability to multitask and simultaneously navigate within multiple computer applications · PC Skills – Prior experience with computers and...
Computer
Seasonal work
Flexible hours
InkPixi
Grove City, PA
25 days ago
Building Automation (BAS) Programmer NC
...Building Automation and HVAC systems designed to help facility managers... ...team, architects, and engineers to design, review, and implement... ...using project hardware and computers Configure user interface and... ...and Visio ~ Must have valid driver's license Preferred...
Computer
For subcontractor
Work at office
MODERNCONTROLS LLC.
New Castle, PA
a month ago
Production Packaging Associate 2nd shift
...unless such accommodation would impose anundue hardship on the Company.EXPERIENCE:• Basic mathematical skills are required.• Basic computer experience.EDUCATION:• Prefer High School diploma or general education degree (GED).TRAINING:• Completion of Altium Production/...
Computer
Local area
Immediate start
Shift work
Afternoon shift
Consolidated Container
New Castle, PA
15 hours ago
Executive Assistant/Estimating Coordinator
...Department. This position requires an individual with excellent computer and mathematical skills, strong interpersonal abilities, and... ...ability to work independently. Willingness to learn new software, systems, and processes. Ability to maintain confidentiality and...
Computer
Full time
Work experience placement
For subcontractor
Work at office
Monday to Friday
Flexible hours
Clearwater Construction
Mercer, PA
a month ago
Sales Consultant Remote
$69k
...relationship-building skills Sales or customer service experience is helpful but not required Qualifications Laptop or desktop computer with a working camera Insurance license required or willingness to obtain one Basic computer skills Must reside in North...
Computer
Remote job
Work from home
Flexible hours
HMG Careers
New Wilmington, PA
4 days ago
Data Entry Product Support - No Experience
$25 - $45 per hour
...attention to detail and curious spirit Be able to work 15-25 hours per week and commit to a certain routine Have access to a computer and a reliable internet connection Have access to a digital camera or cell phone that takes pictures -Be honest and reliable -...
Computer
Hourly pay
Weekly pay
Extra income
Temporary work
Part time
For contractors
Seasonal work
Remote work
Work from home
Flexible hours
GLOCPA
Grove City, PA
1 day ago
Operations Administrative Assistant
...locate the wanted shipments from detained shipments, shipment re-measurement etc. Familiar with computers and be able to use internal and external operations systems such as SISP, ITSM, ICMS, STMS, COS, MCS, HHT, WHHT etc. Ensure outbound / inbound shipments to be...
Computer
Full time
Flexible hours
KEX Express
New Castle, PA
a month ago
Automotive Technician
.... You must be comfortable using the dealership’s computer software and have extensive knowledge of vehicle systems. If you have a “never give up” attitude and are... ...vehicle inspections of all systems, including engine, transmission, and brakes Ensure a high level...
Computer
Flexible hours
Ron's Tire & Service
New Castle, PA
11 days ago
Data Management Specialist
...experience ~4 years of customer service experience required ~ Proven working knowledge of MS Office is required. Knowledge of in-house computer programs preferred ~ Exceptional communication skills, both written and verbal ~ Strong analytical and problem-solving skills...
Computer
Work experience placement
NIXON MEDICAL
New Castle, PA
4 days ago
Community Participation Support Staff
$17.57 per hour
...ODP) in providing direct supervision in 1:1 community setting. Serve as implementor for individual's goals per annual ISP. Complete computer based charting (Therap), data entry including payroll and attendance, time sheets, and other required documentation. Work is...
Computer
Hourly pay
Contract work
Work at office
Monday to Friday
Weekend work
Afternoon shift
MCAR, Inc.
Hermitage, PA
25 days ago
Front Office Clerk/Receptionist
...Prior experience utilizing an electronic records management systems. Responsibilities Telephone Answer calls and forward to... ...and then use to distribute or archive in an efficient manner. Computer Skills Use MS Word to maintain phone list, create mailing labels...
Computer
Work at office
Brandywine Urology Consultants
New Castle, PA
20 days ago

Do you want to receive more vacancies?

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