- Medline Industries, Inc. (Redmond, OR)
- …(Class I- II ), design controls, risk assessments, and the 510k process . Experience with project management and Microsoft project. Experience with project ... analysis of test data. Experience with CAD systems, FEA, Six Sigma, ANDA, ISO/CE Mark, GLP, GMP , GDP, USP testing, and high volume manufacturing processes. 789254 more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking a ** Process Development Engineer II ** to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) group as a part of our Preclinical ... proteins to a diverse range of small-molecules. **As a Process Development Engineer II , a...bench to design and develop scalable, robust and controlled GMP -ready bioconjugation and purification processes + Collaborating with analytical… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …within the Preclinical Manufacturing and Process Development (PMPD) organization. **As a Process Development Engineer II , A Typical Day Might Look ... We are seeking a highly motivated process and automation development engineer to...pilot and manufacturing scales + Transferring automation technology to GMP manufacturing as necessary + Communicating project updates, results,… more
- ThermoFisher Scientific (St. Louis, MO)
- **Job Description** **How will you make an impact?** We are searching for a Process Engineer 2 with education and experience in biopharmaceutical processing or a ... the development, validation, and transfer of manufacturing processes. A Process Engineer 2 routinely supports the ...and procedures with supervision. + Provide scientific expertise for GMP deviations by assessing the impact of major deviations… more
- TE Connectivity (Wilsonville, OR)
- QLTY & RELIABILITY ENGINEER II **At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, ... sustainable and more connected world.** **Job Overview** The Quality Engineer oversees Operations Quality within their prescribed area of functional responsibility… more
- TE Connectivity (Medway, MA)
- QLTY & RELIABILITY ENGINEER II **At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, ... devices and components to deliver an Extraordinary Customer Experience. The Quality Engineer is in charge of Operations Quality within their prescribed area of… more
- Medtronic (Danvers, MA)
- …we can transform healthcare. **A Day in the Life** In this role as a **Materials Engineer II - Extrusion** , you will participate in projects/tasks to meet the ... to flexible composite medical device profiles. As the Materials Engineer II , you will: + Manage specific...teams on operations-based projects. + Order, implement and qualify process equipment and tooling. + Devise and implement cost… more
- PCI Pharma Services (Bedford, NH)
- …and provide technical input to ensure equipment meets project requirements. ** Process Improvement:** + Identify opportunities for process optimization, ... to perform the essential functions. **EXPERIENCE** + 4+ years' experience with GMP , ISO, and/or an FDA-regulated environment is required. + Proficiency in… more
- Abbott (Minnetonka, MN)
- …way doctors treat people with heart arrhythmias, or irregular heartbeats. **Quality Engineer II ** is responsible for developing and maintaining quality ... support. **What You'll Work On** + Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing… more
- Abbott (Westbrook, ME)
- …Our location in **Westbrook, Maine** currently has an opportunity for a **Manufacturing Engineer II .** In this role you will be responsible for supporting ... through sustained manufacturing of FDA regulated products. Support of process development and equipment acquisition. Experience with manufacturing processes,… more
- Abbott (Westbrook, ME)
- …location in **Westbrook, Maine** currently has an opportunity for a **Manufacturing** **Controls Engineer II .** In this role, you will be responsible for ... concept through sustained manufacturing of FDA-regulated products. Completion of process development, equipment acquisition and leadership of supporting development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …by advancing the care of patients with life-threatening diseases. The Senior Biologics Engineer II (Drug Substance) role is focused on commercial manufacture ... a key subject matter expert (downstream) for commercial manufacture oversight, process monitoring, capital improvements, risk assessments, and process validation… more
- Abbott (Pleasanton, CA)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. **Job Title** ** Engineer II , Quality** **Working at Abbott** At Abbott, you can do ... health and get on with their lives. The Quality Engineer assures products, processes, and quality records conform to...record storage for CAPA, RFA, and ICS systems. + Process requests, ensuring owners are assigned, and timely responses… more
- ThermoFisher Scientific (Cincinnati, OH)
- …making sure our food is safe or helping find cures for cancer. As an Engineer II , you will lead capital projects through Design, Construction, and Qualification ... meet changing regulations. + Understanding of quality and regulatory requirements for GMP environments and OSHA standards for facility and utility construction. +… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Job Summary The Automation Engineer II is responsible to monitor and improve automation processes for optimum cost efficiency of production. This role will ... QC, R&D for the engineering and Validation Aspects; maintain VMP and other GMP documents, Support Process Validation and Development Studies. Coordinate and… more
- Terumo Medical Corporation (Elkton, MD)
- Engineer II - Sustaining Date: Apr 24, 2024 Req ID: 3213 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Engineering Terumo Medical ... techniques, DMAIC/six-sigma certification preferred. o Knowledge of equipment and process validations, including development of protocols and execution of protocols.… more
- Abbott (Sylmar, CA)
- …in **Sylmar, CA** , currently has an opportunity for a **Software Quality Engineer II ** **.** This position is responsible for executing and maintaining ... integrity risks. + Design and implement various product and process improvement methodologies (ie, Six Sigma and Lean Manufacturing)....FDA 21 CFR part 820, 21 CFR part 11, GMP , IEEE 1012, IEC 62304 and ISO 13485. Advanced… more
- Danaher Corporation (Chaska, MN)
- …tools that address the world's biggest health challenges. The Technical Support Engineer for Beckman Coulter Diagnostics is responsible for providing real time ... support organization and responds to technical procedural inquiries and concern. The engineer will advise a course of action for problem resolution and provide… more
- Quality Consulting Group (Juncos, PR)
- …suppliers are audited on a regular basis to ensure good manufacturing practices ( GMP ) and quality standards are met. + Evaluates suppliers' internal functions to ... SAP system + Able to work and communicate effectively with other engineer , designers, marketers and suppliers to develop products from concept through… more
- Fresenius Medical Center (Lawrence, MA)
- As a medical device Software Test Engineer in Fresenius Medical Care's Home business unit, you will be able to make a valuable contribution every day to improving ... by analyzing software requirements and following the appropriate software development process . + Ensure quality by developing and executing software test protocols,… more
