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Validation Engineer

Katalyst Healthcares and Lifesciences

Framingham, Massachusetts, USA

Full-time

Responsibilities: Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing trace matrix to ensure requirements are tested to meet the software intended use. Preparing risk assessment for functional requirements and providing testing. strategy, implementing technical & procedural controls as part of mitigation. Preparing SOP/Work instruction for equipment and software-based systems. Requirements: 6 to 8 years of Non-Product Software

Validation Engineer

Katalyst Healthcares and Lifesciences

Hartford, Connecticut, USA

Full-time

Responsibilities: Functional requirement specification, function risk assessment, installation qualification, operational. Qualification, performance qualification, traceability matrix, project release notes, system certification summary). Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing risk assessment for functional requirements and providing testing strategy, implementing technical & procedural controls as part of mitigat

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Pomona, California, USA

Full-time

Roles & Responsibilities: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment,

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Pomona, California, USA

Full-time

Responsibilities and requirements: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk a

Industrial Electrician Needed in Cartersville, $26+/hr., Depending on Experience, Great Benefits!

IK Hofmann

Cartersville, Georgia, USA

Full-time

I.K. Hofmann USA has a need for Industrial Electricians in Cartersville, Ga Job Responsibilities: Install, maintain and repair electrical systems Support daily plant ops through effective repair and troubleshooting of electrical systems and components Responsible for regular inspections of industrial machinery Electrical troubleshooting and repair maintenance on manufacturing machinery Help efficiently carry out all tasks, on a daily basis Essential Job Functions: Must be able to move up to 50

Data Analyst(Payments, Sanctions/Compliance)

Lorvin Technologies

Lake Mary, Florida, USA

Third Party, Contract

Looking for 12+yrs experienced candidate profiles. Summary: Payments: Candidates should have a solid understanding of payment products. While they don t need to master all products, familiarity with at least one, such as real-time payments (e.g., Zelle) or wires, is essential. They should be able to explain the end-to-end process, including how transactions work, how settlements occur, the types of checks involved, and the message types used, such as SWIFT or ISO standards. A detailed understand

Compliance Analyst / NIST / Greater Philadelphia Area Only

Motion Recruitment Partners, LLC

Bryn Athyn, Pennsylvania, USA

Full-time

This local data management company is looking for a Compliance Analyst to join their team. This person will be involved with a wide range of risk and audit engagements, mostly in the government and healthcare sectors. The work involves mostly NIST and HITRUST, but ISO and other common frameworks will appear. It's a great opportunity to get your hands on many different environments, technologies, and frameworks. Ideal candidates for this position will have strong knowledge of NIST. HITRUST experi

Device Engineer

Katalyst Healthcares and Lifesciences

Thousand Oaks, California, USA

Full-time

Responsibilities: Conduct experimental testing to support failure investigations and root cause analysis. Develop and execute test procedures to evaluate device performance and functionality. Analyze test data and apply statistical tools to derive actionable insights. Lead testing efforts for design changes and validate proposed modifications. Support scale-up, global launch, and continuous improvement of drug delivery devices. Collaborate with contract manufacturers and suppliers to ensur

Information Security Risk Analyst

Digitek Software, Inc.

Charlotte, North Carolina, USA

Third Party, Contract

One of our clients is looking Technical Specialist with following skills: The client is seeking a skilled Information Security Risk Analyst on a contract basis to lead the execution of its annual enterprise security risk assessment. This engagement ensures compliance with industry-standard frameworks, supports proactive risk mitigation, & positions NC HIEA for future HITRUST certification. Plan and conduct NC HIEA s annual enterprise security risk assessment using NIST SP 800-30, ISO 27005, or F

Systems Engineer

Katalyst Healthcares and Lifesciences

Skaneateles, New York, USA

Full-time

Responsibilities: Responsible for integration of design and manufacturing process procedures, templates and guidance documents within an ISO 13485 compliant Quality Management System (QMS). Demonstrated ability to communicate with a wide set of stakeholders (Quality, Systems/Risk, PM, RA, Marketing, etc.). Demonstrated understanding of the end-to-end process of identifying stakeholder needs, translation to Design Inputs and tracing these to the Design Outputs. Demonstrated understanding of Syste

Technical Lead

Learn Beyond Consulting LLC

Arlington, Tennessee, USA

Full-time

Technical Lead Location - Arlington, TN Key Responsibilities: Lead technical planning and execution of NPI projects from concept through commercialization.Collaborate with R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure smooth product transition.Own the technical documentation including design history files (DHF), product specifications, and risk assessments.Apply Design for Manufacturability (DFM), Design for Assembly (DFA), and process validation (IQ/OQ/PQ) principle

Validation Engineer

Katalyst Healthcares and Lifesciences

Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functi

Validation Engineer

Katalyst Healthcares and Lifesciences

Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functional

Production Planner IV

Sunrise Systems, Inc.

Irvine, California, USA

Contract

Job Title: Production Planner IV Job ID: 25-08159 Location: Irvine, CA Duration: 18 Months On W2 Contract Job description Responsible for all or a major portion of processing operations in a plant for 2nd shift operations. Responsible for production operations, maintenance, plant engineering, safety, quality control, scheduling, accounting, and workforce level. Promotes good relations with community, government agencies, and customers. May conduct or participate in labor negotiations and admini

QC Analytical Lab Associate - Microbiology

Advantage Technical

Allentown, Pennsylvania, USA

Full-time

QC Analytical Lab Associate - Microbiology Position Type: Contract Position Location: Allentown, PA Position Pay: $24 an hour Position Shift: Monday through Friday, 8:00 am to 4:30 pm New Grads Welcome Key Responsibilities: Is responsible for fulling the lab's requirements for analytical and biological testing. The position is responsible for performing Sterility testing utilizing the direct inoculation method. The candidate must be able to aseptically gown into an ISO 5 clean room. Gowning inc

PERM & REMOTE NUCLEAR QA ( ASME CODE SPECIALIST/Boiler and Pressure Vessel Code )

Seine LLC

Remote

Full-time

TITLE: PERM & REMOTE NUCLEAR QA ( ASME CODE SPECIALIST ) TYPE: PERM / FULL TIME EMPLOYEE WITH BASE, BONUS & BENEFITS LOCATION: REMOTE BUT SUPPORT PACIFIC TIME ZONE INDUSTRY: NUCLEAR ENERGY * MUST HAVE EXCELLENT COMMUNICATION SKILLS Pay and Benefits: The target pay range for this position is $127,104 - $153,401 annually. The full pay range is $113,955 - $178,237. POSITION SUMMARY: The Quality Assurance team is responsible for the development, implementation and maintenance of the Seine Client

Buyer/ Purchaser

Express Employment Professionals

Cleveland, Ohio, USA

Full-time

#LORAIN Express Employment is seeking a Senior Fabricator experienced within the manufacturing industry that also possesses experience and skills in buying/purchasing. Salary range is based on experience Job Description: This buyer would be searching, verifying, and purchasing materials for a small fabrication shop located in Cleveland, OH. The buyer is responsible for utilizing drawings, bills of materials, and blueprints to purchase all required materials and services using an integrated m

IT - Project Manager

V2Soft

Pittsburgh, Pennsylvania, USA

Contract

V2Soft is a global leader in IT services and business solutions, delivering innovative and cost-effective technology solutions worldwide since 1998. We have headquartered in Bloomfield Hills, MI and have 16 offices spread across six countries. We partner with Fortune 500 companies to address complex business challenges. Our services span AI, IT staffing, cloud computing, engineering, mobility, testing, and more. Certified with CMMI Level 3 and ISO standards, V2Soft is committed to quality and se

Manufacturing Plant Engineer

Jobot

Pleasant Hill, Missouri, USA

Full-time

Well-established US-based manufacturer in need of a junior Plant Engineer to join the team! Strong benefits, TRAINING, culture, stability, and team! This Jobot Job is hosted by: Catherine Reid Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $55,000 - $85,000 per year A bit about us: We are a 30yr old US-based manufacturer offering stability, growth, work/life balance, and a great team! Why join us? We pride ourselves on our people and off

Electronic Assemblers

LSI Staffing

Grand Prairie, Texas, USA

Full-time

LSI Staffing is currently looking to hire an assembler to perform assembly, quality assurance, and factory testing of battery energy storage systems. This applicant would be responsible for mechanical assembly of enclosures, electrical wiring of the system, factory testing, and maintaining good documentation for quality assurance. The electrical wiring will include both AC and DC wiring with wire sizes ranging from 22 awg to 500 MCM. Enclosures can range from 16" x 16" wall mount enclosures to f