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Regulatory Affairs Manager

LMI Government Consulting (Logistics Management In

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Frederick, Maryland, USA

Contract

Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week. This position requires the ability to pass a T1/NACI securit
Posted 60+ days ago | Updated 10 hours ago

Principal Engineer - Thermal Engineering

Amgen Inc

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Remote or Thousand Oaks, California, USA

Full-time

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients ea
Posted 60+ days ago | Updated 1 hour ago

Utility Engineer- FMCG Industry

DBSI Services

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Pineville, Louisiana, USA

Full-time

Benefits: 401(k) 401(k) matching Relocation bonus Job Title: Utility Engineer Location: Pineville, Louisiana Job Description & Skill Requirement: Key Responsibilities: 1. Industrial HVAC System Design & Engineering Design and develop HVAC systems for industrial applications, including air handling units (AHUs), ventilation, ductwork, chilled water systems, and process cooling systems. Perform heat load calculations, psychrometric analysis, and airflow distribution design for critical process
Posted 60+ days ago | Updated 1 hour ago

Automation Engineer

Katalyst Healthcares and Lifesciences

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Thousand Oaks, California, USA

Full-time

Responsibilities: Manage day-to-day support of ATO Drug substance operations. Represent plant automation team in Area WCTs. Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including External Workers (EWs), onboarding the EWs, and ensuring the direct reports' adherence to Client training requirements. Represent Plant Automation team during the develo
Posted 60+ days ago | Updated 1 hour ago

Principal Engineer, Utilities (Days)

Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. T
Posted 21 days ago | Updated 1 hour ago

Associate Director, Process Engineering

Takeda pharmaceutical

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Round Lake, Illinois, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda's Round Lake aseptic fill/finish and Packaging facility, the Associate Director, Process Engineering will
Posted 60+ days ago | Updated 1 hour ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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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
Posted 23 days ago | Updated 1 hour ago

Business Analyst - Data and Analytics

Advanced Software Talent

•

South San Francisco, California, USA

Contract

This is a hybrid contract for candidates that are located in Northern California and 100 % remote for candidates outside the area. Direct W2 contractors only! No 3rd party agencies! We are not able to sponsor any H1B Visa! Description BA, Clinical Stage Cell Therapy Process & Analytical Development - Data and Analytics The Business Analyst (BA) is a self-motivated expert in business analysis who is passionate about improving healthcare. They are flexible and dedicated to providing value to patie
Easy Apply
Posted 60+ days ago | Updated 2 days ago

Associate Engineer, Facilities & Maintenance

Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f
Posted 34 days ago | Updated 1 hour ago

Engineer, Facilities & Maintenance-Cold Storage

Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f
Posted 35 days ago | Updated 1 hour ago

Staff Quality Engineer

Abbott Laboratories

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Plymouth, Minnesota, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo
Posted 60+ days ago | Updated 23 hours ago

Sr. Engineer

Becton Dickinson & Company

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Holdrege, Nebraska, USA

Full-time

Job Description Summary The Sr. Engineer provides leadership and resources to explore, develop & bring new products to the Holdrege facility and works and in partnership with the team to improve existing processes and operations. The Sr. Engineer is responsible for the repair and maintenance of the automated material handling equipment as well as the sterilization vault. Must be able to troubleshoot and diagnose robotics and material handling equipment malfunctions and make necessary repairs and
Posted 60+ days ago | Updated 1 hour ago

Principal IT Systems Engineer - SecOps

Regeneron Pharmaceutical

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Rensselaer, New York, USA

Full-time

We are seeking a highly skilled and proactive Principal IT Systems Engineer (SecOps) to join our dynamic team. The role will play a critical role in maintaining the reliability, availability, and performance of our IOPS IT server and infrastructure environments, as well as managing Identity and Access Management (IAM) solutions. This position is instrumental in ensuring the stability and operational efficiency of our IT infrastructure while strictly adhering to Good Manufacturing Practice (GMP)
Posted 60+ days ago | Updated 1 hour ago

Site Automation Project Engineer

Apex Systems

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Philadelphia, Pennsylvania, USA

Full-time

Job#: 2074785 Job Description: Position Title: Site Engineering Automation Project Engineer Department: Site Engineering Job Location: Philadelphia, PA Contract & Onsite role Position Summary: The Site Engineering Automation Project Engineer will provide automation engineering design and project management support for a facility project located in Philadelphia, PA. This role will primarily be responsible for the Building Automation System (BAS), Environmental Monitoring System (EMS), and as
Easy Apply
Posted 60+ days ago | Updated 2 hours ago

Senior Manager, Site IT Lead

Gilead Sciences, Inc.

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Frederick, Maryland, USA

Full-time

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great l
Posted 60+ days ago | Updated 1 hour ago

Staff Automation Engineer, Systems

Johnson & Johnson

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Añasco, Añasco, Puerto Rico

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 11 days ago | Updated 1 hour ago

Quality - QA Specialist

Futran Solutions

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CH

Full-time

Job Description: The Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support. You will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release. This position may also be cross trained to cover other QA functions as needed. Responsibilities: Provides oversight for CMO Batch Product
Easy Apply
Posted 60+ days ago | Updated 18 days ago

Process Engineer

Novartis

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Indianapolis, Indiana, USA

Full-time

Job Description Summary The Process Engineer will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level. Supervise plant engineering team providing technical assistance to the function a
Posted 60+ days ago | Updated 1 hour ago

Staff Engineer II, Firmware (Hybrid)

Becton Dickinson & Company

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Remote or Milpitas, California, USA

Full-time

Job Description Summary Seeking an experienced staff level Firmware Development Engineer to play a leading role in developing high quality instrument control firmware for BD's line of flow cytometers. As a leading member of the firmware development team, you will be responsible for architecting, developing, debugging, and documenting robust and reliable firmware to satisfy the product requirements. Must be detail-oriented, process-focused, and results-driven. Are you ready to make a difference
Posted 60+ days ago | Updated 1 hour ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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Remote or Santa Monica, 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
Posted 59 days ago | Updated 1 hour ago