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Actuarial Consultant - P&C Insurance Pricing and Predictive Modeling

Aon Corporation

•

Chicago, Illinois, USA

Full-time

Actuarial Consultant - P&C Insurance Pricing & Predictive Modeling This is a hybrid role with the flexibility to work both virtually and from our Chicago, New York City or Bloomington, MN offices Aon is in the business of better decisions At Aon, we shape decisions for the better to protect and enrich the lives of people around the world. As an organization, we are united through trust as one inclusive team and we are passionate about helping our colleagues and clients succeed. What the day wil
Posted 11 days ago

Software Engineer with Syncade @ Boston, MA

Hermitage Info Tech, LLC.

•

Boston, Massachusetts, USA

Contract

Day 1 onsite Role: Software Engineer with Syncade Boston, MA Qualifications Thorough understanding of ISA S88 and S95 models Knowledge of CSV, GAMP and 21 CFR Part 11 regulations Bachelor's degree in Chemical/Electrical/Computer Engineering, or equivalent combination of education and technical experience Minimum four (4) years of design/development/deployment experience in Emerson Syncade MES DeltaV Batch programming or Syncade Recipe development experience Work experience in a Pharmaceutical/
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Posted 1 day ago

Sr DeltaV Automation Engineer

Intone Networks Inc.

•

Michigan, USA

Full-time, Third Party, Contract

Sr DeltaV Automation Engineer - Muskegon, MI - onsite Job Summary: This is an onsite role to help with commissioning efforts of a DeltaV system and mentor other Junior and Intermediate Engineers. The client and the project team have been working very well together with high collaboration, communication, adaptability, and a good sense of camaraderie making the work environment enjoyable and engaging. We're looking someone who is strong technically but also a great team player, collaborative, an
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Posted 36 days ago | Updated 21 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Albany, New York, USA

Full-time

Responsibilities: Execute validation activities across the full equipment lifecycle (FAT, SAT, Commissioning, DQ, IQ, OQ, PQ). Apply GAMP 5 methodology in a GMP-regulated environment. Support Greenfield project initiatives and equipment startup. Handle deviations, change controls, and validation deliverables. Collaborate with cross-functional teams including QA, Engineering, and Manufacturing. Requirements: Prior experience with fill-finish equipment including syringe assembly, serializati
Posted 1 day ago | Updated 8 hours ago

Lead/Sr Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Muskegon, Michigan, USA

Full-time

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols. The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams
Posted 8 hours ago

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
Posted 6 days ago | Updated 8 hours ago

Senior Pharma GxP Project Manager with a strong background in SAP S/4 HANA validation

Pioneer Corporate Services Inc

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Foster City, California, USA

Third Party, Contract

Job Title: Senior Pharma GxP Project ManagerLocation: Hybrid Foster City, CA (Locals or nearby states preferred)Duration: 12 Months Job Description:We are seeking a Senior GxP Project Manager with a strong background in SAP S/4 HANA validation and Life Sciences industries. The role demands excellent stakeholder and change management skills, hands-on validation expertise, and solid project leadership. Must-Have Skills: 15 20 years of overall experience 8+ years in Computer System Validation (CSV)
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Posted 9 days ago | Updated 9 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Raritan, New Jersey, USA

Full-time

Roles & Responsibilities: 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like Service NOW, Automation tools, JIRA. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. Application of FDA guidance's a
Posted 17 days ago | Updated 8 hours ago

Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

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Walnut Creek, California, USA

Full-time

Job Description: 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 3 days ago | Updated 8 hours ago

CSV Lead

Prudent Technologies and Consulting

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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 7 days ago

SAP Finance FICO Consultant

URSI Technologies Inc.

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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 16 days ago | Updated 8 days ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

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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 14 days ago | Updated 8 hours ago

Medical Device Engineer

Katalyst Healthcares and Lifesciences

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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 15 days ago | Updated 8 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

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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 19 days ago | Updated 8 hours ago

Reliability Engineer

Cushman & Wakefield

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Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary This individual will provide support for GxP Facility Operations/Engineering department at Vertex GxP sites as part of the Reliability Engineering team. The ideal candidate will be responsible for ensuring the reliability and performance of our equipment/systems through Reliability best practices and continuous improvement initiatives. This role will also execute documentation/forms/spreadsheets to roll out Maintenance and Reliability Best
Posted 18 days ago | Updated 8 hours ago

Need Senior Manufacturing Quality Engineer

Montek System

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Ayer, Massachusetts, USA

Contract, Third Party

Onsite, Devens location Work Schedule: Mon - Fri, First shift (8:30AM - 5PM) Top Skills/Must Haves: Quality Control Equipment experience preferredTechnical WriterInvestigations/Deviation experience preferred Job Description/ Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review andapproval of Investigations and Corrective Actions. Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectati
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Posted 2 days ago

SUD Validation Engineer

Thermo Fisher Scientific

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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 31 days ago | Updated 8 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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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 8 hours ago

QA Lead Technical Operations

TSR Consulting Services, Inc.

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Harvard, Massachusetts, USA

Contract

Our client, a leading pharmaceutical company, is hiring a QA Lead - Technical Operations, on a contract basis. Job ID: 82974 Work Location: Devens, MA - on site Education/Experience: Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering biochemistry, or related discipline, or its equivalent is preferred. Advanced Level of relevant experience in a GMP, Google Cloud Platform, or GXP with at least 8 years focused on product quality. Preferred
Posted 2 days ago | Updated 5 hours ago

Validation Lead

TechDigital Corporation

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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 30 days ago