- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Experience Good knowledge of pharmaceutical manufacturing processes, control systems, process equipment , validation practices/processes, and current ... Position SummaryThe Process Engineering Manager leads a team of engineers and mechanics in the manufacturing of aseptic pharmaceutical products. Areas of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company's Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused scientist.This ... in a laboratory settingExperience with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, mechanical testing,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …training new employees is an essential skill for this position.Strong competency in medical validation practices. Automotive PPAP process is also ... risk analysis in manufacturing design, then goes into addressing risk in process validations, and continues with overseeing risk using statistical quality control… more
- Merck & Co. (Rahway, NJ)
- …NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.)Must be innovative and drive new ... in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is preferredFill/finish process scale-up, Drug Delivery and/or… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …infrastructure and systems (WFI, Clean Steam, Pharmaceutical/Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in aseptic manufacturing. In ... will include:Strong technical skills, be the Subject Matter Expert (SME) from equipment Utilities-HVAC systems. Deep technical expertise in all systems under his/her… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …systems (Ethernet) 10 plus years of experience at a medium to large scale medical device, Pharmaceutical or biotechnology process firm in an automation role is ... make minor changes) desired Understanding of Network Architecture, VM Machines and IT Equipment We commit to an inclusive recruitment process and equality of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy ... vendor management, issues, deviations, corrections and remediation efforts for facility, equipment , systems and processes in support of personalized cell therapy… more
- BioAgilytix (Durham, NC)
- …their expertise in molecular biology, further developing their skillset in the development and validation of PCR assays. If you are a person who is energized by ... then you'll be right at home here at BioAgilytix.Essential ResponsibilitiesCompile/ process data (make power export)Prepare summary tablesPeer review raw dataOrder… more
- Novo Nordisk Inc. (Durham, NC)
- …Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & ... Benefits including 12 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life… more
- Tris Pharma (Monmouth Junction, NJ)
- …manages and tracks IT budget, IT procurement and major capital equipment and department expendituresPro-actively Communicates to senior leadership on IT portfolio, ... various business functions (ie, Finance, Manufacturing, Quality, Commercial, Regulatory, Medical , etc.) including related business applications business data and… more
- LSI Solutions (Victor, NY)
- …of protocols supporting the topics of Facility, Utility, and Cleanroom Qualification, Equipment Qualification, Process Validation , Cleaning Validation , ... to test and validate the performance and reliability of equipment and processes. + Conduct qualification testing in accordance...above. + Thorough knowledge of regulations and requirements for process validation for medical devices… more
- Teleflex (Morrisville, NC)
- …components * Principles and practices of professional engineering * Regulations pertaining to medical device and process equipment design and modification ... Process Validation Engineer **Date:** Dec 27,...reviews per said procedures. * Develops, maintains, and publishes equipment validation plans for assigned projects with… more
- Danaher Corporation (Fargo, ND)
- …development and delivery of solutions that safeguard and improve human health. The Process Validation Engineer II is part of the Technical Operations Department ... discoveries worldwide. You will be a part of the Process Validation team and report to the...will have the opportunity to: + Develop and review validation documents for facilities, equipment , and processes.… more
- Verista (Bloomington, IN)
- … & change control). Specifically, + Provide quality support and oversight (approval) of process and equipment validation and change control records and ... validation . + Perform quality oversight & approval of equipment , process , and validation documentation...issues in a timely and effective manner + Prior medical device validation experience preferred. + Experience… more
- Boehringer Ingelheim (St. Joseph, MO)
- …in comprehension/application of USDA and FDA/EU regulatory requirements for validation /qualification of equipment / process /cleaning of regulated biological ... project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues...and is responsible for assuring compliance of validated systems, process , equipment to current cGMP, FDA, EU,… more
- Curia (Albuquerque, NM)
- …and Responsibilities include the following. + Develop and continuously improve site validation program including equipment , process , cleaning, sterilization ... validation , re-qualification, and re- validation documents, including equipment and manufacturing process protocols, deviations, and final reports… more
- Takeda Pharmaceuticals (Lexington, MA)
- …combination thereof. + Demonstrate basic experience in validation disciplines ( equipment , facilities, critical systems, computer, cleaning, process to also ... Collaborate to conduct risk & impact assessments. + Use validation test equipment , such as, Ellabs loggers...(eg Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process materials, process equipment , facilities… more
- Astellas Pharma (Westborough, MA)
- …areas based on experience: + Process Validation /PPQ + Aseptic Process Simulation Validation + Analytical Equipment Qualification/ Validation + ... world. We are committed to turning innovative science into medical solutions that bring value and hope to patients...Validation Specialist will ensure that all critical GMP equipment and systems are validated and maintained in compliance… more
- Teva Pharmaceuticals (Salt Lake City, UT)
- …**The opportunity** **POSITION SUMMARY:** This position is responsible for qualification/ validation of equipment , facilities, cleaning and manufacturing ... and utility. * Responsible for providing technical input for the qualification and validation of manufacturing and packaging equipment as well as facilities. *… more
- Kedrion Biopharma (Melville, NY)
- …and perform Qualification and Validation activities related to process , cleaning, and equipment . Partners with Engineering, Maintenance, Manufacturing, ... of Fractionation intermediates and final sterile drug product. + Support execution of process validation activities. + Performs generation of summary reports for… more
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