gamp Jobs in illinois

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Validation Engineer

Katalyst Healthcares and Lifesciences

Libertyville, Illinois, USA

Full-time

Responsibilities: Lead validation efforts for injection molding machines, auxiliary equipment (e.g., dryers, chillers, robots), and integrated automation systems. Develop and execute validation protocols (SAT, FAT, IQ, OQ, PQ) for molding and downstream equipment. Support the qualification of new production lines involving injection-molded components. Perform process characterization, capability studies, and stability testing for moulded parts. Collaborate with tooling, manufacturing, and q

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

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Libertyville, Illinois, USA

Full-time

Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for the development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work a

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

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

Payroll Accounting Consultant

Grepforce LLC

Remote

Contract

What we look for: Bachelor's degree in Accounting, Finance, or related field.5+ years of general ledger and payroll accounting experience.Strong understanding of GAAP and payroll accounting practices.Proficiency in Excel and experience with ERP systems (e.g., NetSuite, Workday, SAP).Strong attention to detail and analytical skills.Excellent organizational and communication skills.Proven ability to work independently and meet deadlines in a dynamic environment.CPA preferredExperience in a high-gr

Accounting Supervisor

Sunrise Systems, Inc.

Deerfield, Illinois, USA

Contract

Our client, a leading medical devices company, is looking for an Accounting Supervisor. This is for an initial duration of 5 months and is located in Deerfield, IL. 100% onsite Schedule: Monday through Friday on-site, 8am-5pm or 9am-6pm Top 3 skills: Problem-solving abilitiesTechnical skillsHas a positive attitude that works well with the team Responsibilities: General accounting for US and Canada to include month-end close, entry preparation, reconciliations, support audit request, and GAAP re

Director, Radiopharma Technology Strategy and Operations

GE Healthcare

Arlington Heights, Illinois, USA

Full-time

Job Description Summary The Director, Radiopharma Technical Strategy & Operations will play a pivotal role in providing high-level scientific and technical leadership within the Manufacturing Sciences and Technology (MSAT) team. This position reports directly to the Head of MSAT and is responsible for driving innovation, technical strategy, and process optimization for the radiopharmaceutical manufacturing operations, particularly in the PET radiotracer space. With deep expertise in radiochemist

Raw Materials Technical Specialist

Aditi Consulting

Remote or Cambridge, Massachusetts, USA

Contract

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t

Tagetik Technical Support

OnwardPath Technology Solutions LLC

Remote

Contract

Finance/Accounting Degree preferred, and/or at least 10 years in accounting (focus in Financial Closing and Consolidation required; exposure to Foreign Currency is preferred)Deep understanding of the Tagetik architecture and modules (Financial Close, Budgeting & Planning, IFRS/GAAP Consolidation, Financial Reporting).Experience in configuring and customizing Tagetik solutionsExperience with SDLC (System Design Life Cycle) and deployment in Tagetik projects

Process Engineer

Katalyst Healthcares and Lifesciences

Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.

Excellent Job Opportunity || Digital Asset Resource (Blockchain) || Manassas, VA

Sysmind, LLC

Illinois, USA

Part-time, Contract, Third Party

Dear Job Seeker My name is Leo and I work as a Sr. US IT Recruiter with SYSMIND. We have been serving fortune 500 clients in the industry to bridge their staffing gap since the past 25 years. I have an Excellent opportunity with one of our clients. Thanks & Regards Leo Sr US IT Recuiter SYSMIND SYSMIND LLC is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without any discrimination. We promote and support a diverse workforce at all l

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Finance Analyst ONLY W2

Aziro Technologies LLC

Remote

Contract

SKILLS NEEDED Excellent understanding of US GAAP, revenue recognition, and financial analysis, with advanced knowledge in Profit and LossExcellent analytical skillsExcellent business application skills (e.g., Microsoft Excel). Must be able to make pivot tables, analyse revenue, costs, apply procedures, determine actions to be taken and prepare summary reports.Knowledge of SAP ERP, booking manual Journal Entries, Intercompany Billings is mandatorySuperior communication and influencing skills, sho

Field Service Engineer I (lab equipment)

Thermo Fisher Scientific

Colorado, USA

Full-time

Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Field Service Engineer (lab equipment) When you join us at Thermo Fisher Scientific, you'll be part of an inquis

Validation Engineer

Katalyst Healthcares and Lifesciences

Springfield, Illinois, USA

Full-time

Job summary: Seeking a Facilities Validation Specialist who will be responsible for working across two state-of-the-art medical device facilities. They will have a long-term contract position with significant project ownership an opportunity to work with advanced cleanroom environments and warehouse facilities. Responsibilities: Lead facility commissioning activities across multiple sites. Conduct temperature and humidity mapping studies. Perform cleanroom validation for Class 6, 7, and 8 envi

Business Analyst

TriosysIT Inc.

Remote

Contract

We are seeking an experienced Business Analyst with strong domain knowledge in title insurance and property closing processes. The ideal candidate will play a key role in bridging the gap between business needs and technical solutions within the mortgage and real estate ecosystem. Gather, analyze, and document business requirements related to title insurance, property closing, and associated workflows. Work closely with cross-functional teams, including underwriting, escrow, compliance, and tech

Business Analyst

TriosysIT Inc.

Remote

Contract

We are seeking an experienced Business Analyst with strong domain knowledge in title insurance and property closing processes. The ideal candidate will play a key role in bridging the gap between business needs and technical solutions within the mortgage and real estate ecosystem. Gather, analyze, and document business requirements related to title insurance, property closing, and associated workflows. Work closely with cross-functional teams, including underwriting, escrow, compliance, and tech

Firewall Security Engineer - Remote / Telecommute

Cynet Systems

Remote

Contract

Job Description: Candidate must have experience in Azure cloud. Minimum experience required - 10 years. Expertise level on cloud knowledge should be 40% and Firewall knowledge should be 60%. Expertise on PALO ALTO Firewall. Expertise on load balancer (WAF). Responsibilities: Cloud network expertise: virtual networks, hybrid connectivity, firewalls, DNS, and network threat management. Cloud security along with the ability to support compliance with industry security standards. Research and archit