41 - 60 of 125 Jobs

Engineer II, Molding

ICU Medical, Inc.

Dublin, Ohio, USA

Full-time

Job Description Position Summary The Engineer II, Molding is responsible for supporting injection molding improvements through adherence to established product design, scientific injection molding process, tooling, resin, and equipment. The key responsibility of this position is to exercise judgement with injection molding resources, support projects within a product family and take action while adhering to defined procedures. The incumbent will also liaise with the Tooling, Molding, Engineerin

Validation Support Engineer

Katalyst Healthcares and Lifesciences

Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S

Senior Staff Engineer, R&D Packaging

Stryker

Fremont, California, USA

Full-time

Work Flexibility: Hybrid Stryker Neurovascular focuses on saving lives: Treating and preventing strokes is our mission. From the moment a product is manufactured to its use in the angio suite, the packaging and labeling make a difference in so many ways. As a Senior Staff Engineer, R&D Packaging, you will be a key member on new product development project teams, driving the design and development of packaging components, artwork, design verification, shelf life testing, label design, and suppor

Validation Engineer

Katalyst Healthcares and Lifesciences

Los Angeles, California, USA

Full-time

Responsibilities: Coordinate sample builds and maintain traceability documentation. Prepare process validation protocols (IQ/OQ/PQ) and generate accompanying test plans/reports. Route and track all protocol documents for proper approvals. Characterize new process equipment. Document experiments and results in engineering reports. Create and present summary presentations to management. Collaborate and coordinate with outside vendors. Provide technical support to engineering and provide li

Senior Validation Engineer

Takeda pharmaceutical

Lexington, Massachusetts, 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 Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

Kansas City, Missouri, USA

Full-time

Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manager. Engage

Automation Engineer

Judge Group, Inc.

Lithia Springs, Georgia, USA

Contract

Location: Lithia Springs, GA Salary: $50.00 USD Hourly - $65.00 USD Hourly Description: The engineers will work closely with our internal teams and technology partners to ensure seamless connectivity, data acquisition, and automation across manufacturing assets and systems. The engineers will also be expected to understand and support automation systems in compliance with Good Manufacturing Practices (GMP) and regulatory requirements specific to the animal health industry. Key Responsibilit

Senior Manufacturing Engineer

Plymouth, Minnesota, USA

Full-time

Contract Senior Manufacturing Engineer Duration: 6 Month Contract Are you a seasoned Manufacturing Engineer ready to make an impact in the fast-paced world of medical devices? We're looking for a Senior Manufacturing Engineer for a 6-month contract to support new product launches and design updates for innovative drug-device combination products. This is an excellent opportunity to drive design transfer, improve manufacturing processes, and collaborate cross-functionally with a dynamic, quality-

CQV Engineer

Katalyst Healthcares and Lifesciences

Holly Springs, North Carolina, USA

Full-time

Responsibilities: Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC). Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis. Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis,

Process Engineer III

Thermo Fisher Scientific

Lebanon, Tennessee, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you join us at Thermo Fisher Scientific, you'll be part of a team that shares your passion for exploration and discovery! Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical

Senior Manufacturing Engineer

Olympus Corporation of the Americas

Brooklyn Park, Minnesota, USA

Full-time

Working Location: MINNESOTA, BROOKLYN PARK Workplace Flexibility: Onsite For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn mo

Validation Engineer

Salas O'Brien Engineers Incorporated

Houston, Texas, USA

Full-time

At Salas O'Brien we tell our clients that we're engineered for impact. This passion for making a difference applies just as much to our team as it does to our projects. That's why we're committed to living our values every day: inspiring, achieving, and connecting as shared owners of our success with a focus on a sustainable future. Building for the long-term means that all of our team members can expect to work on amazing projects with a people-first approach to problem solving. It also means

Process Engineer

Merck KgaA

Indianapolis, Indiana, USA

Full-time

Work Location: Indianapolis, Indiana Shift: No Department: LS-SC-POEMA Clinical Tech Services Recruiter: Katherine Hall Hiring Manager: Stan Le This information is for internals only. Please do not share outside of the organization. Your Role: Provide key engineering support and project coordination for all phases of plant operations, including interfacing with internal and external clients for product technology transfers and manufacturing. Offer technical support for processes and product in

Automation Control Engineer

Katalyst Healthcares and Lifesciences

South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa

Senior Manufacturing Engineer - Beverage Experience Highly Preferred

Jobot

Coppell, Texas, USA

Full-time

Hands-On Role, Path to Engineering Director This Jobot Job is hosted by: Tracy Hann Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $100,000 - $135,000 per year A bit about us: We are a privately held manufacturer in the health and wellness industry, producing a broad portfolio of nutritional supplements, ready-to-drink beverages, and personal care items. With decades of experience and operations across the southern U.S., we manage the full

Quality Assurance Specialist (Two openings)

Johnson and Johnson

Wilson, North Carolina, USA

Full-time

Job DescriptionAt 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 hu

Validation Engineer NPI

Katalyst Healthcares and Lifesciences

Irving, Texas, USA

Full-time

Roles and responsibilities: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA. 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred. Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical

Process Engineer III

Novo Nordisk Inc

Lebanon, New Hampshire, USA

Full-time

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, a

Validation Engineer

Katalyst Healthcares and Lifesciences

Durham, North Carolina, USA

Full-time

Job Description: Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program. This position provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. This

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron