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CSV Lead

Prudent Technologies and Consulting

•

Raritan, New Jersey, USA

Third Party, Contract

Role - CSV Lead Location - Raritan, NJ(Hybrid) Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool val
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Posted 4 days ago

SAP Finance FICO Consultant

URSI Technologies Inc.

•

Remote

Contract

SAP Finance FICO Consultant San Francisco, CA Remote Remote Qualifications The ideal candidate will have hands-on experience in SAP S4HANA and ECC, a strong understanding of GAMP 5, cGMP, and SOX compliance requirements, and proven application support skillsKey Responsibilities: Provide application support for SAP FICO modules within a regulated IT environmentTranslate business requirements into SAP solutions using SAP Best Practices, FIORI apps, and embedded analyticsJob description : 9+ to 15
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Posted 14 days ago | Updated 6 days ago

Engineer II, Quality

Thermo Fisher Scientific

•

Asheville, North Carolina, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Join Thermo Fisher Scientific Inc. as an Engineer II, Quality in Asheville, and be part of an exceptionally dedicated team! We are a company that thrives on innovation and collaboration, and we are looking for an ambitious individual who is ready to contribute to our world-class projects. This is an outstanding opportunity to work in an environ
Posted 32 days ago | Updated 6 hours ago

Software Application Programmer/Coder - II

Judge Group, Inc.

•

Temple Terrace, Florida, USA

Contract

Location: Temple Terrace, FL Description: Our client is currently seeking a Software Application Programmer/Coder - II Responsible for all aspects of the development & implementation of one large project and provides a single point of contact for those projects - original concept thru final implementation. Functional Expert: Acts independently or member of a highly skilled technical team responsible for fulfilling complex business requirements with the implementation of reliable & efficient a
Posted 60+ days ago | Updated 2 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 11 days ago | Updated 5 hours ago

Processing Operator - 3rd Shift

BEPC, Inc.

•

Sturgis, Michigan, USA

Contract

BEPC has an open position for a Processing Operator - 3rd Shift in Sturgis, MI WEEKLY PAY!! Contract: W2 Length (12-month contract with possibilities for extensions) Benefits: Medical, Dental, Vision, and Paid Life Insurance Education: High School Diploma Schedule: 6:00PM 6:00AM (12hr shift) Pay Rate: $19.00 to $20.02 Description: The Processing Operator is responsible for the manufacturing of liquid pediatric and medical nutritional products. The job requires the lifting and physical hand
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Posted 5 days ago

Medical Device Engineer

Katalyst Healthcares and Lifesciences

•

North Chicago, Illinois, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 12 days ago | Updated 5 hours ago

SUD Validation Engineer

Thermo Fisher Scientific

•

Logan, Utah, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 28 days ago | Updated 5 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil
Posted 16 days ago | Updated 5 hours ago

Component Engineer - Validation (IQ/OQ/PQ)

Katalyst Healthcares and Lifesciences

•

Irvine, California, USA

Full-time

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards. Roles & Responsibilities: Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports.
Posted 8 days ago | Updated 5 hours ago

Veterinary Technical Solutions Specialist

Cynet Systems

•

Missouri, USA

Contract

Job Description: Responsibilities: Receive product inquiries, complaints, and adverse event reports from veterinarians, veterinary staff, pet owners, sales personnel, distributors, or other internal contacts via phone, email, or mail. Provide information and support regarding proper product use, extra-label use, literature requests, adverse events, lack of efficacy, and product or packaging defects. Maintain high technical and clinical expertise related to client products; continuously upgrade k
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Posted 4 days ago

C&Q Engineer

Sunrise Systems, Inc.

•

Wilson, North Carolina, USA

Contract

Job Title: C&Q Engineer Job ID: 25-09377 Location: Wilson, NC 27893 Duration: 17 Months On W2 Contract Job Purpose The C&Q Engineer is responsible for the execution of the defined C&Q scope of the following areas Black Utilities and HVAC. These are Client-side roles and key responsibilities are meeting the agreed objectives regarding time, schedule and functionality according to EHS, URS and GMP requirements. The C&Q Engineer SME is responsible for planning and executing commissioning activit
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Posted 4 days ago | Updated 13 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Portsmouth, New Hampshire, USA

Full-time

Responsibilities: Hands on experience in Implementation & Validation of various computerized systems like MES (Syncade) & PLC (COTS). Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements. Experience at working independently as well as in a team-oriented, collaborative environment is essential. Author and Execute CSV life cycle documentation. Requirements: CSV experience of 4+ years.
Posted 60+ days ago | Updated 5 hours ago

Master Maintenance Technician (Utilities)

St. Paul Beverage Solutions

•

Saint Paul, Minnesota, USA

Full-time

Job DescriptionJOB DUTIES AND RESPONSIBILITIES \n Perform maintenance and/or repairs (planned, unplanned, emergency) on production, processing, and packaging equipment as well as utility related equipment or systems, following all safety procedures \n Perform preventative maintenance; perform routine inspections of equipment for assessment of reliability and performance \n Read, analyze, and interpret technical procedures, electrical schematics, service manuals, and work orders to perform req
Posted 15 hours ago

Maintenance Technician

Maintenance Engineering Solutions

•

Massillon, Ohio, USA

Full-time

Job DescriptionJob DescriptionThe Maintenance Technician is responsible for maintaining and repairing equipment, eliminating stops and breakdown related losses. Maintenance Technicians are self-starters who are responsible for production and packaging equipment. This role will answer maintenance calls, perform preventative maintenance (PM s), and make line improvements throughout the facility. We are currently hiring for night shift (7:00PM 7:00AM) on a 2-2-3 schedule. Starting pay of $34.85-$38
Posted 3 days ago | Updated 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

South Carolina, USA

Full-time

Job Description: This position is responsible for writing, implementing, analysing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. Will include developing and accessing following the Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validati
Posted 17 hours ago | Updated 5 hours ago

Validation Lead

TechDigital Corporation

•

King of Prussia, Pennsylvania, USA

Third Party, Contract

Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterf
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Posted 27 days ago

Maintenance Worker I

Pyramid Consulting, Inc.

•

Swiftwater, Pennsylvania, USA

Contract

Immediate need for a talented Maintenance Worker I. This is a 07+months contract opportunity with long-term potential and is located in Swiftwater, PA (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 25-79911 Pay Range: $28 - $31/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Troubleshoot equipment failures
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Posted 5 hours ago

Seeq Implementation & Support Consultant-W2 ONLY

VetForce Solutions

•

Remote

Contract

ResponsibilitiesDuring Implementation Phase: Lead release management and environment coordination for Seeq (SaaS) Establish and enforce SDLC best practices, including code workflows and version control Support integration across ~12 data sources (e.g., OSI PI, Data Lakes, Unicorn, Nova) Drive CSV/CSA efforts, including documentation, risk assessment, and audit readiness Contribute to SOP authoring, compliance strategy, and data governance Post-Go-Live Operations: Develop advanced analytics and d
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Posted 1 day ago

Documentation Specialist

LanceSoft Inc.

•

Athens, Georgia, USA

Contract

Job Title: Documentation Specialist Location : Athens GA 30601 Duration : 12 months Duties: Tech-savvy information management specialist to support GI Development sites / activities.Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems.Electronic Document Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration.
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Posted 12 days ago