- J&J Family of Companies (New Brunswick, NJ)
- …leadership responsibilities. The ATMP Technical Support Lead is responsible for providing expert engineering technical support and guidance; in the key areas ... design for Advanced Therapies & Medicinal Products. + Provide expert engineering technical support and guidance; in...is required. + Strong Advanced Therapies & Medicinal Products process engineering expertise is required. + Large… more
- PCI Pharma Services (Bedford, NH)
- …the future of PCI. We're looking for a **hands-on, highly skilled Principal Process Engineer** to lead complex engineering projects from concept to completion. ... and manufacturing systems for maximum efficiency and reliability. + **Own the Process ** - From URS and risk assessments to vendor management and factory/site… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …matter expert is preferred. + Technology transfer and equipment / process validation experience of aseptic , parenteral fill/finish operations preferred. + ... design, installation and qualification.Acts as fill / finish subject matter expert (SME), coordinating with Combination Products, Validation and Quality Assurance… more
- Actalent (St. Louis, MO)
- …purification and filtration/HPLC, including propagation of mammalian cell culture, aseptic cell culture operations, and execution of large-scale production ... controls and calibrators, completing batch records following cGMPs. + Perform in- process assays using equipment such as spectrophotometers, pH meters, and clinical… more
- BeOne Medicines (Pennington, NJ)
- …automated inspection machines. + Expert level knowledge in IQ/OQ/PQ and process engineering + Expertise in late stage/commercial Drug Product technology ... / Control Systems + Deviation Assessments / Investigations + SAP, LIMS, CMMS, Veeva + Expert level knowledge in all Drug Product aseptic filling operation + … more
- Bristol Myers Squibb (Indianapolis, IN)
- …(CQV) documents and protocols for highly specialized facility, utility, analytical, and process equipment. The Senior Validation Engineer utilizes a broad range of ... engineering disciplines to ensure seamless progression from construction to...onboarding advanced technologies (such as isolator-based sterile systems), guiding process development, supporting GMP operations, managing investigation and CAPA… more
- Actalent (St. Louis, MO)
- …team, ensuring all tasks are completed accurately and contributing to process improvement initiatives. Responsibilities + Execute manufacturing batch records, work ... controls and calibrators, completing batch records following cGMPs. + Perform in- process assays using equipment such as spectrophotometers, pH meters, and clinical… more
- Actalent (St. Louis, MO)
- …bulk reagents per manufacturing procedures with limited supervision. + Engage in process improvement projects and perform in- process assays using various ... setting, or related field. + Experience with cell culture, chromatography, and aseptic techniques. + Knowledge of cGMP practices and chemical concepts. + Bachelor's… more
- Merck (Wilmington, DE)
- …chromatography, tangential flow filtration and filling. + Execute the Engineering Batches, Process Performance Qualifications and commercial manufacturing. ... care. Whether you're an engineer, scientist, operator, or quality expert , your work here will contribute to life-changing therapies...out the following:** + Lead and engage with the engineering design firm in detailed design on all aspects… more
- Merck (Wilmington, DE)
- …project phase including equipment Commissioning & Qualification, IOQ, etc. + Perform process and facility fit activities to enable engineering and qualification ... care. Whether you're an engineer, scientist, operator, or quality expert , your work here will contribute to life-changing therapies...out the following:** + Lead and engage with the engineering design firm in detailed design on all aspects… more