- BioAgilytix (Boston, MA)
- …according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of ... enable life-changing, life-saving therapeutics to the patients who need them.The Technical Analyst II/III will perform responsibilities of a traditional lab analyst,… more
- Novo Nordisk Inc. (Durham, NC)
- …Perform & oversee change control activities for QC equipment & systems Support systematic problem solving related to equipment qualification Reviews ... present technical /scientific documents & reports preferred Understanding of QC equipment/ systems , end user functionality & life-cycle management a plus We commit… more
- Tris Pharma (Monmouth Junction, NJ)
- …directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, ... other, and we believe in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris has… more
- Merck & Co. (Durham, NC)
- …documentation associated with equipment, cleaning, and sanitization/sterilization activities. Support technical studies including engineering runs, stability ... are consistent and reliable through challenges against pre-established criteria. - Provide technical support to help develop and execute project plans; and… more
- Merck & Co. (Durham, NC)
- …, Chilled water, Glycol, plant steam and condensate systems .Electrical distribution systems , Motor control systems , generators and ATS systems ... NC..- Must be able to read electrical prints, P&ID's and understand P&ID control loops. Extensive industrial experience involving utility systems with a strong… more
- Merck & Co. (Rahway, NJ)
- …pharmaceutical ingredients, intermediates, seeds and cell banks) through direct oversight, support and technical advice, counseling to site leadership, and ... documentation and deviation investigations.Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control… more
- Novo Nordisk Inc. (Boulder, CO)
- …and/or stakeholder requirements Acts in role as primary process SME for the Change Control process at NN Boulder Support internal and external (CMO) stakeholders ... Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing...Acts as SME and local Super User for NN systems , specifically for the Change Control and… more
- Merck & Co. (Durham, NC)
- …, -70 freezers and 2-8C cold rooms, refrigerators, heating hot water skids, incubators, etc.) Support Systems (plant steam condensate systems in relation to ... air handling unit maintenance, operations, and reliability)Automated systems (eg, Distributed Control System, Programmable Logic Controllers)Maintenance… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position ... projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing… more
- Merck & Co. (Durham, NC)
- … Equipment (eg washers, autoclaves, tube welders/sealers); Utility systems (eg Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis ... skids, vapor compression stills, compressed gas systems ) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC),… more
- Catalent (St. Petersburg, FL)
- …it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).Provide QA Technical support during the development and manufacturing improvements throughout ... has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control ,...a representative for Catalent's strategic clients as well as support the clients with products that have technical… more
- Merck & Co. (Rahway, NJ)
- … site operations. Primary assignments: HVAC/Refrigeration equipment, BAS (Building Automation Systems ), -70 Freezers and 2-8C Cold rooms). Support equipment (eg, ... generators, water-for-injection generation/distribution, reverse osmosis skids, vapor compression stills).Automated systems (eg, distributed control system, programmable logic… more
- Merck & Co. (Rahway, NJ)
- …organization, the Bioprocess Drug Substance Commercialization (BDSC) department provides the technical process leadership and laboratory capabilities in support ... with internal and external program partners, this individual will support late stage and commercial program activities within BDSC.Scope includes:Participates… more
- Merck & Co. (Durham, NC)
- …washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic ... Controllers (PLC), robotics, Building Automation System (BAS))-Clean-In-Place (CIP) Systems -Maintenance Equipment (eg tools and calibration equipment)- Support to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the design, implementation, start-up and troubleshooting of automation and plant floor control systems . Under close supervision is responsible for the design ... engineering start-up, documentation and validation activities of new and modified control systems Participates in the development and implementation of… more
- Catalent (St. Petersburg, FL)
- …Computerized System Validation (CSV) guidelines, policies, and procedures for control systems , automation, analytical equipment, and IT applications.Ensure ... Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The Department has the responsibility… more
- Merck & Co. (Durham, NC)
- …and leak detectors) to facilitate analysis and repair of equipment and control systems .Identifies revisions, deletions, or additions to the calibration and ... a member of the EMSS. The EMSS team provides technical , calibration, maintenance, and engineering support for...work instructions. The Senior Calibration Technician will use computerized systems such as SAP for PM data entry and… more
- Merck & Co. (Rahway, NJ)
- …Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems .-Integration of control systems with MES, Quality, and ... and Skills:Effective oral / written communication skills.Experience with DeltaV process control systems .- -Relevant training and experience with Implementation… more
- Merck & Co. (Rahway, NJ)
- …the scientific community to influence the field.BPR&D includes three lab-facing technical functional areas: Process Cell Sciences (PCS), Upstream Process Development ... in contributing to one or more of the three technical functional areas mentioned above.As a Scientist in BPR&D,...team members to design and develop robust processes in support of early- and late-stage biologics. You will innovate… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. The Deviation ... will lead the investigation of deviations that occur in operations and perform technical writing of investigations Author and manage the investigations to meet key… more
