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.
Roles and responsibilities include:
- 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.
Education and experience:
- 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.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Computer System Validation Engineer in New Wilmington, PA vacancy
- ...preparation, •Rooming patients, • Answering/returning patient calls, • Data entry • Implementing physicians orders. • Strong computer and data-entry skills • Excellent communication and organizational skills • Ability to work independently and as part of a...ComputerFull timeWork at office
The Kidney Group
New Castle, PA10 days ago - ...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...SuggestedFull timeWork at officeWeekend workDay shift
$69k
...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...ComputerRemote workWork from homeFlexible hoursHMG Careers
Volant, PA1 day ago- ...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...ComputerWork at officeLocal area
- ...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...ComputerFull time
$18 - $20 per hour
...contributing to a high-performing team, this role is perfect for you! Requirements Qualifications: Strong data entry and computer skills with a typing speed of at least 40 words per minute. Excellent written and verbal communication abilities. Proven...ComputerHourly payRemote workPJ Fitzpatrick
New Castle, PA18 days ago- ...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, PA3 days ago - ...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...ComputerTemporary workFor contractorsWork at office
$25 per unit
...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...ComputerExtra incomeFull timePart timeSecond jobRemote workWork from homeFlexible hoursEarn Haus
Volant, PA12 days ago- ...unless such accommodation would impose an undue 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/...ComputerSeasonal workLocal areaImmediate startShift workNight shift
Altium Packaging
New Castle, PA4 days ago $13 per hour
...purchase orders to appropriate vendor to order parts Record warranty parts returned Create special ordered parts on dealership computer system and notify ASM, technician or client upon receipt Review special order parts tracking Process and close open invoices Compare invoices...ComputerHourly payPreston Auto Group
Neshannock, PA5 days ago$25 per hour
...Authorized to work in the United States ~ Passes a standard employment background and credit check ~ Own a laptop or desktop computer Why Work With Us Fully remote — work from home on a flexible schedule, 5 to 20 hours per week Dedicated...ComputerRemote workWork from homeFlexible hoursReeledge
New Wilmington, PA5 days ago$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...ComputerFull timeShift work- ...clinical healthcare experience Current Pennsylvania practical nursing license in good standing Current CPR and First Aid certification Computer proficiency Willingness to complete DHS Direct Care Training during your orientation period Personal care or assisted living...ComputerFull timeRelocation packageShift work
- ...a secure designated area. Assist the store manager in maintaining the store building, parking lot, exterior signage/lighting, computer hardware, in-store service/test equipment, and delivery vehicles. All other duties as assigned. SKILLS/EDUCATION/KNOWLEDGE...ComputerLocal areaFlexible hoursShift workNight shiftWeekend workAfternoon shift
O'Reilly Auto Parts
Neshannock, PA5 days ago - ...bonus and opportunities for flexible pay options. You will support residents in regaining function within a SNF setting and collaborate with the OT and DOR to achieve therapy goals. Required: Associate’s Degree, OTA license, and basic computer skills. #J-18808-Ljbffr...ComputerFull timeRelocation packageFlexible hours
Saber Healthcare Group
New Castle, PA2 days ago - ...photography skills, with attention to detail and consistency. Ability to handle vehicles carefully while photographing and inventorying. Basic organizational and computer skills. Full-time availability. Compensation: Pay is competitive and based on experience....ComputerFull time
Diehl Automotive
Sharon, PA4 days ago - ...participates when additional coverage is needed. Cooperates with and supports other branches to meet company objectives. Oversees computer system adjustments required to maintain an accurate yard inventory. Maintains positive relations with suppliers and vendors Performs...ComputerWork at officeFlexible hours
$15 - $18 per hour
...card transactions, assisting with online order pickups, answering customer questions, and maintaining a clean front-end area. This role requires basic computer skills, communication skills, and the ability to stand for extended periods. Average pay: $15 - $18 per hour.ComputerHourly payBest Buy
New Castle, PA4 days ago- ...required to complete the job. Tools used on the job Hand and power tools Vehicle Dump truck, various vans Other Computer Requirements: High school diploma or GED Benefits: ~ Comprehensive health benefits ~ Paid Time Off ~ Life Insurance provided...ComputerCurrently hiring
George Junior Republic
Grove City, PA23 days ago - .... 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...ComputerFlexible hours
Car Connection
New Castle, PA2 days ago $790 per week
...online surveys and remote studies you take part in from home — you pick the ones that fit you. All you need: a phone, tablet, or computer with a camera and an internet connection. No degree, no résumé, no experience. Why Maxion Research: genuine paid studies...ComputerRemote workMaxion Research
Hermitage, PA3 days ago- ...Comfortable working with mobile dentistry and equipment - preferred Experience working with military - preferred Proficient with computer programs Must have weekend availability With over three decades of experience, we are a trusted industry leader. Our...ComputerLocal areaWeekend work
DOCS Health
New Castle, PA2 days ago - ...shopping or checkout \n Complete other duties as assigned \n \n Minimum Qualifications \n \n \n ~6 Months Experience using a computer, including inputting, accessing, modifying, or outputting information \n ~6 Months Experience using common retail technology,...ComputerPart timeLocal areaFlexible hours
Lowes
Sharon, PA10 days ago - ...document incidents and resolutions within the case management system Deliver supplies and materials to and from office locations in... ...Maintain accurate inventory of district resources, supplies, and computer equipment Maintain up‑to‑date technical knowledge of supported...ComputerPart timeWork experience placementSeasonal workWork at officeRelocationFlexible hours
- ...layout. Ensure the store maintains high standards of housekeeping and visual merchandising. Utilize proficiency in various computer systems and applications, including POS, CRM systems, and inventory management tools. Enforce the store's inventory security measures...ComputerFull time
Daily Thread
Grove City, PA4 days ago - ...qualifications, including Diagnostic, Electrical and Engine Repair.Dexterity, requiring a steady hand... ...customer service skills and basic computer competencies.Positive, friendly attitude,... ....Qualifications:Must have a valid Pennsylvania Safety Inspection License.Emissions...ComputerLocal area
Bill McCandless Ford
Mercer, PA1 day ago - ...standards of housekeeping and visual merchandising to create an inviting store environment. Utilize proficiency in various computer systems and applications, including POS, CRM systems, and inventory management tools. Implement the store's inventory security measures...ComputerPart time
Daily Thread
Grove City, PA4 days ago $21.91 per hour
...shiftPush or pull up to 100 lbs. at times during the shiftSafe operation of forklift truck in congested areasPerform transactions on computer with high level of accuracyInvolves repetitive motion of hands and arms for extended periods of time and use of laddersMust be...ComputerCurrently hiringNight shiftAfternoon shiftJoy Baking Group
Hermitage, PA6 hours ago$35 - $45 per hour
...Family dental insurance Paid holidays after 90 days Vacation time up to 3 weeks 401k matching Cloud based software Computer or tablet in each room Digital X-rays Ultrasonic scaler Supportive and caring team Compensation: ~$35-$45/hour...ComputerFull timePart timeWork at officeFlexible hoursGentle Family Dentistry
Hermitage, PA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Computer System Validation Engineer. Be the first to apply!
