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The Senior QA Specialist Computer Systems Validation is responsible for providing quality oversight of Catalent's Engineering, Quality Control, IT and Validation groups to ensure compliance with applicable US regulations, guidance's, industry standards and Catalent policies/procedures supporting the company's commitment to quality.\n","descriptionText","Senior QA Specialist, CSV Abacus Marketing & Communications Senior QA Specialist Computer Systems Validation The Senior QA Specialist Computer Systems Validation is responsible for providing quality oversight of Catalent's Engineering, Quality Control, IT and Validation groups to ensure compliance with applicable US regulations, guidance's, industry standards and Catalent policies/procedures supporting the company's commitment to quality.","shortDescription","Senior QA Specialist Computer Systems Validation

The Senior QA Specialist Computer Systems Validation is responsible for providing quality...","location","locations",[451],{"_452":453,"_454":455,"_456":457,"_458":459,"_460":461},"formatted","Glen Burnie, MD, United States, 21060","city","Glen Burnie","state","MD","country","United States","postal_code","21060","companyName","Abacus","salaryMin","salaryMax","salaryDescription","https://us.thebigjobsite.com/redirectfeedjob?jobid=930AB7E78C1D53AF55D70E40515F72F6&source=mediabistroxmlus&utm_source=mediabistroxmlus&jobSiteKey=58ED0AACB2E55EF8752272E8956095CA","companyDescription","companyWebsite","displayLogo","https://www.mediabistro.com/public/images/desk-100x50.webp","displayThumbnail","displayHeadline","Work at Abacus","isManualPosted","costPerClick",0.15,"displayUrl","fullUrl","https://www.mediabistro.com/jobs/2966067558-senior-qa-specialist-csv","strippedDescription","Senior QA Specialist Computer Systems ValidationThe Senior QA Specialist Computer Systems Validation is responsible for providing quality oversight of Catalent's Engineering, Quality Control, IT and Validation groups to ensure compliance with applicable US regulations, guidance's, industry standards and Catalent policies/procedures supporting the company's commitment to quality.\n","parsedLocation",{"_452":485,"_486":199,"_487":199,"_454":455,"_456":457,"_458":459,"_460":461},"Glen Burnie, MD, United States","street1","street2","displayPublishedAt","10 hours ago","shortTitle","shortLocation","level","searchCompanyPath","/jobs?keyword=Abacus","searchLocationPath","/jobs?location=Glen+Burnie%2C+MD%2C+United+States","searchTitlePath","/jobs?keyword=Senior+QA+Specialist%2C+CSV","featuredCompany",{"_431":501,"_15":502,"_503":434,"_76":504,"_505":506,"_248":507,"_448":508,"_509":-5,"_510":-5,"_511":-5,"_512":-5,"_513":514,"_515":516,"_470":504,"_478":517,"_472":504},211,"Mansueto Ventures","agency","https://production-rails-default.s3.us-east-2.amazonaws.com/public/legacy-logos/109473.JPG","slug","mansueto-ventures-careers","

Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

","New York, NY","coloredLogo","logoAttachment","thumbnail","thumbnailAttachment","hexCode","#080D0C","headline","Publisher of Inc. and Fast Company, empowering innovators and entrepreneurs.","/companies/mansueto-ventures-careers","hasJobSubmission","isSavedJob","similarJobs",[522,536,554,568,588],{"_435":434,"_439":523,"_470":471,"_462":463,"_248":524,"_446":525,"_433":434,"_113":442,"_437":199,"_438":199,"_472":471,"_448":199,"_449":526,"_431":531,"_473":474,"_436":120,"_488":532,"_478":533,"_490":442,"_491":534,"_493":494,"_495":535,"_497":498},["D",1774105200000],"Senior Qa Specialist Computer Systems Validation

The Senior QA Specialist Computer Systems Validation is responsible for providing quality oversight of Catalent's engineering, quality control, IT, and validation groups to ensure compliance with applicable US regulations, guidance, industry standards, and Catalent policies/procedures supporting the commercial GMP manufacturing of biological d...\n","Senior Qa Specialist Computer Systems Validation

The Senior QA Specialist Computer Systems Validation is responsible for providing quality...",[527],{"_458":459,"_454":528,"_452":529,"_456":457,"_460":530},"Harmans","Harmans, MD, United States, 21077","21077",["B","2961924133"],"19 hours ago","/jobs/2961924133-senior-qa-specialist-csv","Harmans, MD, United States","/jobs?location=Harmans%2C+MD%2C+United+States",{"_435":434,"_439":537,"_470":471,"_462":538,"_248":539,"_446":540,"_433":434,"_113":541,"_437":199,"_438":199,"_472":471,"_448":199,"_449":542,"_431":547,"_473":548,"_436":120,"_488":549,"_478":550,"_490":541,"_491":545,"_493":551,"_495":552,"_497":553},["D",1773406800000],"Mirus Consulting Group","mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.

Position Summary\nThe

CSV Specialist

will support the validation lifecycle of computerized and automated systems associated with the PSA Syringe Filling Machine Control System upgrade. This role focuses on Computer System Validation (CSV) activities while working closely with Automation, Engineering, Manufacturing, and Quality to ensure the validated state of upgraded systems including robotics, motion control, PLCs, HMIs, servo systems, VFDs, I/O, and safety components. The project involves replacing obsolete components—including the Adept robot, motion systems, drives, and legacy Windows XP‑based HMI—with modern, validated hardware and software platforms. The CSV Specialist will ensure compliance with GMP, 21 CFR Part 11, EU Annex 11, data integrity principles (ALCOA+), and site SOPs including IM‑S‑230 for computerized system lifecycle management.

Key Responsibilities\nComputer System Validation

Develop, review, and execute CSV deliverables for the upgraded robot, PLC, motion control, HMI, VFDs, and related computerized systems.

Author and maintain:

System Requirements / URS / FRS

Risk Assessments (including Data Integrity Risk Assessments)

Traceability Matrices

IQ/OQ/PQ protocols and execution evidence

Validation Summary Reports

Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and site procedures.

Validate new Windows OS‑based HMI, software applications, and system interfaces.

Support validation of safety functions including Safe‑Cell routines, door contacts, and light curtain logic.

Commissioning & Qualification Collaboration

Support alignment with C&Q activities for:

Commissioning

Installation Qualification (IQ)

Operational Qualification (OQ)

PSA Robot & Motion Control C&Q

PSA Isolator C&Q

Deviations, test witnessing, and approval workflows

Documentation & Lifecycle Management

Responsible for document control for all validation/C&Q documentation:

Load, store, and maintain documents in SharePoint and ALM tools

Route documents for review/approval

Revise documents to address comments and ensure compliance

Maintain documentation structure and quality throughout the project lifecycle

Support updates to SOPs and forms required by the upgrade

Change Control, Testing & Compliance

Perform CSV impact assessments for software, firmware, OS updates, robot programming, PLC logic, and automation configurations.

Support deviations, CAPAs, version control, and backup/restore verification.

Ensure audit‑ready test evidence aligned with ALCOA+ principles.

Participate in project meetings, design reviews, and technical discussions.

Minimum Requirements

BS or higher in Engineering, Computer Science, Chemistry, or related discipline.

Experience working in pharmaceutical manufacturing.

Demonstrated experience in Computer System Validation in GMP‑regulated environments.

Experience with Commissioning & Qualification operations.

Familiarity with Change Control processes.

Strong knowledge of cGMP and regulatory validation requirements.

Proficient documentation skills in English; strong MS Office capability.

Experience with ALM platforms for protocol execution and document control.

Bilingual (English/Spanish).

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

#J-18808-Ljbffr\n","mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validati...","CSV Specialist",[543],{"_458":459,"_454":544,"_452":545,"_456":546},"Bradenton","Bradenton, FL, United States","FL",["B","2873008654"],"Work at Mirus Consulting Group","8 days ago","/jobs/2873008654-csv-specialist","/jobs?keyword=Mirus+Consulting+Group","/jobs?location=Bradenton%2C+FL%2C+United+States","/jobs?keyword=CSV+Specialist",{"_435":434,"_439":555,"_470":471,"_462":556,"_248":557,"_446":558,"_433":434,"_113":559,"_437":199,"_438":199,"_472":471,"_448":199,"_449":560,"_431":562,"_473":563,"_436":120,"_488":564,"_478":565,"_490":559,"_491":545,"_493":566,"_495":552,"_497":567},["D",1773910800000],"Weil Group, Inc","A national pharmaceutical company is seeking a Quality Assurance Specialist to maintain GMP compliance and support computerized systems validation initiatives. This role requires a Bachelor's degree in science and a minimum of 6 years of experience in a pharmaceutical environment. Ideal candidates should be fully bilingual in Spanish and English, possess strong problem-solving skills, and have the capability to make informed recommendations on quality matters. This position may require irregular hours and weekend availability.\n#J-18808-Ljbffr\n","A national pharmaceutical company is seeking a Quality Assurance Specialist to maintain GMP compliance and support computerized systems validation ...","Senior QA Specialist: GMP, CSV, EN/ES (Pharma)",[561],{"_458":459,"_454":544,"_452":545,"_456":546},["B","2933345397"],"Work at Weil Group, Inc","3 days ago","/jobs/2933345397-senior-qa-specialist-gmp-csv-en-es-pharma","/jobs?keyword=Weil+Group%2C+Inc","/jobs?keyword=Senior+QA+Specialist%3A+GMP%2C+CSV%2C+EN%2FES+%28Pharma%29",{"_435":434,"_439":569,"_470":471,"_462":570,"_248":571,"_446":572,"_433":434,"_113":573,"_437":199,"_438":199,"_472":471,"_448":199,"_449":574,"_431":580,"_473":581,"_436":120,"_488":582,"_478":583,"_490":573,"_491":584,"_493":585,"_495":586,"_497":587},["D",1773644400000],"Dawar Consulting","A leading consulting firm seeks an experienced Senior Computer System Validation Consultant in San Diego to provide Quality Assurance oversight for computerized systems used across laboratory, manufacturing, and quality operations. This role involves leading validation activities throughout the system lifecycle, ensuring compliance with global regulatory standards. The ideal candidate holds a Bachelor's degree and has 8+ years of experience in the life sciences industry, with strong knowledge of FDA regulations and GxP systems.\n#J-18808-Ljbffr\n","A leading consulting firm seeks an experienced Senior Computer System Validation Consultant in San Diego to provide Quality Assurance oversight for...","Senior CSV Consultant: Lead GxP Validation & Compliance",[575],{"_458":459,"_454":576,"_452":577,"_456":578,"_460":579},"San Diego","San Diego, CA, United States, 92189","CA","92189",["B","2898197305"],"Work at Dawar Consulting","6 days ago","/jobs/2898197305-senior-csv-consultant-lead-gxp-validation-compliance","San Diego, CA, United States","/jobs?keyword=Dawar+Consulting","/jobs?location=San+Diego%2C+CA%2C+United+States","/jobs?keyword=Senior+CSV+Consultant%3A+Lead+GxP+Validation+%26+Compliance",{"_435":434,"_439":589,"_470":471,"_462":590,"_248":591,"_446":592,"_433":434,"_113":593,"_437":199,"_438":199,"_472":471,"_448":199,"_449":594,"_431":600,"_473":601,"_436":120,"_488":602,"_478":603,"_490":593,"_491":604,"_493":605,"_495":606,"_497":607},["D",1773079200000],"Katalyst Healthcares and Life Sciences","Roles & Responsibilities:

Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC.\nuthor, review, approve, and execute Computer System Validation (CSV) lifecycle documentation.\nManage CSV projects, including team coordination, scheduling, reporting, and KPIs.\nPerform change assessments for DCS (DeltaV) and MES (Syncade) systems.\nSupport commissioning and qualification of DCS software, particularly DeltaV.\nEnsure compliance with regulatory standards like 21 CFR Part 11 and Annex 11.\nCollaborate effectively in both independent and team-oriented work environments

","Roles & Responsibilities:

Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC.\nuth...","Senior CSV Consultant",[595],{"_458":459,"_454":596,"_452":597,"_456":598,"_460":599},"Portsmouth","Portsmouth, NH, United States, 00215","NH","00215",["B","2833046682"],"Work at Katalyst Healthcares and Life Sciences","12 days ago","/jobs/2833046682-senior-csv-consultant","Portsmouth, NH, United States","/jobs?keyword=Katalyst+Healthcares+and+Life+Sciences","/jobs?location=Portsmouth%2C+NH%2C+United+States","/jobs?keyword=Senior+CSV+Consultant","actionData","errors"]