regulatory affairs Jobs

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Process EngineerJob Title - Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Jersey City, New Jersey, USA

Full-time

Responsibilities: This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site. Develop and execute current state operational readiness assessment pFMEAs. Report findings with recommendations and escalate critical risks/gaps identified timely. Support resolution of identified gaps, id

Senior Process EngineerJob Title - Senior Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Validation Engineer IIJob Title - Validation Engineer II

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Athens, Georgia, USA

Full-time

Responsibilities: Perform Smoke studies and assist in semiannual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas. Has worked with Ellabs data loggers and software. Write and execute protocols and complete final reports. Understanding of cleaning validation concepts and principles. Understands pharma grade utilities (water HVAC, gases). Requirements: Support Maintenance, Engineering

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Responsibilities: NPD, NPI, Process & product development. Process and Equipment Validation. Process Characterization. good manufacturing practices and documentation. Process Improvement. Requirements: GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs. Knowledge in Experiment design and SPC. Management of statistical procedures. Strong creative, analytical and problem-solving skills. Comprehension of standard costs and

Compliance EngineerJob Title - Compliance Engineer

JobotCompany Name - Jobot

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Troy, Ohio, USA

Full-time

Electrical Engineers with UL compliance experience take a closer look! This Jobot Job is hosted by: Jenner Wiggins Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $100,000 - $130,000 per year A bit about us: We are a manufacturer specializing in industrial lithium-ion batteries, battery charger systems, and power converters. With a global presence, we emphasize sustainability by utilizing renewable energy in our production processes. Why j

Systems EngineerJob Title - Systems Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Senior Process Engineer IIIJob Title - Senior Process Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Dublin, California, USA

Full-time

Responsibilities: Design History File: Ensure that the transferred process is adhering to the Device Master Record. Process Analysis and Documentation: Analyse current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities. Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure smooth transition between facilities. Cross-functional Collaboration:

Assistant Data Center Project ManagerJob Title - Assistant Data Center Project Manager

HDR, Inc.Company Name - HDR, Inc.

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Omaha, Nebraska, USA

Full-time

At HDR, our employee-owners are fully engaged in creating a welcoming environment where each of us is valued and respected, a place where everyone is empowered to bring their authentic selves and novel ideas to work every day. As we work to weave diversity, equity, and inclusion into our work and foster a sense of belonging throughout the company and within our communities, we constantly ask ourselves: What is our impact on the world? Watch Our Story:' ' Each and every role throughout our organ

Engineer, Principal Regulatory - License Renewal & Power UprateJob Title - Engineer, Principal Regulatory - License Renewal & Power Uprate

Constellation EnergyCompany Name - Constellation Energy

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Warrenville, Illinois, USA

Full-time

WHO WE ARE As the nation's largest producer of clean, carbon-free energy, Constellation is focused on our purpose: accelerating the transition to a carbon-free future. We have been the leader in clean energy production for more than a decade, and we are cultivating a workplace where our employees can grow, thrive, and contribute. Our culture and employee experience make it clear: We are powered by passion and purpose. Together, we're creating healthier communities and a cleaner planet, and our

Engineer, Principal Regulatory - License Renewal & Power UprateJob Title - Engineer, Principal Regulatory - License Renewal & Power Uprate

Constellation EnergyCompany Name - Constellation Energy

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Warrenville, Illinois, USA

Full-time

Engineer, Principal Regulatory - License Renewal & Power UprateJob Title - Engineer, Principal Regulatory - License Renewal & Power Uprate

Constellation EnergyCompany Name - Constellation Energy

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Warrenville, Illinois, USA

Full-time

Engineer III, QAJob Title - Engineer III, QA

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

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Greenville, North Carolina, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Summary: We are seeking an experienced and meticulous QA Engineer to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will have a strong background in quality validation processes, excellent analytical skills, and a dedication to maintaining the highest standards of product quality. Typical work hours are Monday - Friday from 8a - 5p, but the role also requires this in

LNG Principal EngineerJob Title - LNG Principal Engineer

BHE GT&SCompany Name - BHE GT&S

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Lusby, Maryland, USA

Full-time

BHE GT&S JOB DESCRIPTION BHE GT&S has an exciting career opportunity as an LNG Principal Engineer at our Cove Point facility located in Lusby, MD. RESPONSIBILITIES This role is the primary technical expert contact for all matters related to the liquefied natural gas (LNG) process technology employed in the facility. Provides Operations and Maintenance departments with LNG export process expertise to assist in maximizing system performance and output.Participates in development of LNG capital

Manufacturing Engineer IJob Title - Manufacturing Engineer I

Russell, Tobin & AssociatesCompany Name - Russell, Tobin & Associates

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Eden Prairie, Minnesota, USA

Full-time, Contract

The Science Team at Russell Tobin & Associates supporting the Engineering team that has an opening for Manufacturing Engineer I in Eden Prairie, MN!Position Summary: We are seeking a Manufacturing Engineer to support production operations through process improvement and engineering support. This entry-level position is ideal for individuals with a technical background and a passion for driving operational efficiency in a manufacturing environment. Additional Details: Contract Length: 12 months w

EngineerJob Title - Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Los Angeles, California, USA

Full-time

Roles & Responsibilities: 4-6 years Minimum bachelor's or master's degree in a health-care related field Strong knowledge of GMP (Good Manufacturing Practices) and ISO 13485 standards, along with regulatory affairs. Strong creative, analytical, and problem-solving skills. Proficient in interpreting data and compiling detailed reports. Expertise in Design Quality, Good Manufacturing Practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, and Manufacturing Processes. Expertis

Process EngineerJob Title - Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Dublin, California, USA

Full-time

Job Summary: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules. Responsibilities: Design History File: Ensure that the transferred process is adhering to t

EH&S EngineerJob Title - EH&S Engineer

FlextronicsCompany Name - Flextronics

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Columbia, South Carolina, USA

Full-time

Job Posting Start Date 04-29-2025 Job Posting End Date 06-29-2025 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord

Software Applications Test Engineer - SES Team (25-140) E4 / COS-83Job Title - Software Applications Test Engineer - SES Team (25-140) E4 / COS-83

Apex SystemsCompany Name - Apex Systems

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Colorado Springs, Colorado, USA

Full-time

Job#: 2074359 Job Description: CANDIDATES MUST HOLD AN ACTIVE SECRET SECURITY CLEARANCE TO BE CONSIDERED FOR THE ROLE AND WORK AS A W2/USC 25-140 Software Applications Test Engineer-SES Team RA E4 COS-83 Secret IAT - Level II Technical Bachelors Degree (Mathematics, Science, Engineering, or Computer Science) or significant professional experience. Masters degree highly desired. Required Experience/Knowledge: Prior experience in an Agile development process; Prior experience testing and verifyi

IT Security ConsultantJob Title - IT Security Consultant

The Select GroupCompany Name - The Select Group

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Toronto, Ontario, Canada

Full-time

Security Consultant II (Remote - Canada) Join our clients Cybersecurity Professional Services team as a Security Consultant II, Cybersecurity Awareness & Training, where you'll play a key role in supporting client engagements focused on phishing simulations and security awareness initiatives. If you have hands-on experience in cybersecurity education and a proven track record of developing and delivering impactful security awareness programs, we'd love to hear from you. Applicants must be autho

Sr Human Factors EngineerJob Title - Sr Human Factors Engineer

ACL DigitalCompany Name - ACL Digital

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Thousand Oaks, California, USA

Full-time

Open market rate In person at ATO or remote (remote candidates must be especially exceptional with experience as the preference is onsite) Backfill- scrubbed resume attached Interview Process: To be considered, candidates MUST supply an online portfolio We will be holding a supplier call should resumes not align once shortlisted but hoping they are as we have sourced for this role over the past few years NOTE: This is expected to be a contract position within the Human Factors and Usability