- Merck & Co. (Durham, NC)
- …Programmable Logic Controllers (PLC))-Maintenance Equipment (eg tools and calibration equipment)Lab equipment / instrument calibrations and maintenance; Autoclaves ... to process equipment as needed.Installation, testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.Develop standard… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Job ResponsibilitiesDevelop calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy ... and support equipment Develop, test, and validate, automated and manual calibration proceduresDesign calibration schedules and intervals for site… more
- Merck & Co. (Durham, NC)
- …Logic Controllers (PLC)Clean-In-Place (CIP) SystemsMaintenance Equipment (eg tools and calibration equipment)Assist with execution of calibration , automation, ... (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration /Maintenance Database SystemsEffective maintenance, troubleshooting, and problem-solving skills requiredRotational… more
- Tris Pharma (Monmouth Junction, NJ)
- …Eval instrument perf. + troubleshoot instrument malfunction. Process + report calibration results using instrument specific data processing software. Complete timely ... analytical method verifications and method transfers; performing routine metrology, calibration , maintenance and troubleshooting of analytical instrumentation in QC… more
- Merck & Co. (Durham, NC)
- …procedures (SOPs), engineering change request (ECRs), preventative maintenance (PM) plans/ calibration procedures, task lists, etc., as required Order and maintain ... (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration /Maintenance Database Systems Must demonstrate good verbal and written… more
- Piper Companies (Durham, NC)
- …bioburden testing, microbial enumeration, platingSupport routine preventive maintenance and calibration of equipment Qualifications of the Associate: 0-2 years of ... bioburden, endotoxin, full-process manufacturing, biologics, deviations, junior role, maintenance, calibration , FDA, EMA, biopharmaceuticals, quality assurance, QA #pando#LI-DNPPandoLogic. ,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Testing) Completes routine equipment maintenance May support equipment calibration /validation or method verification Participates in systematic problem solving ... and laboratory investigations May update standard operating procedures with help Delivers training on low complexity tasks Performs troubleshooting with support Contributes to cLEAN activities (eg PDCA, SPS, VSM) May lead or support projects with limited scope… more
- Eisai, Inc (Nutley, NJ)
- …development of analysis plans, programming of core economic models, model calibration , model validation, interpretation of model results and sensitivity analyses, ... protocol, technical report and manuscript writing.Leads interactions with academic institutions and vendors, develops and maintains client relationships.As project lead/principal investigator has project budget, deliverable and timeline responsibility;… more
- Eisai, Inc (Exton, PA)
- …of equipment to support commercial manufacturing.Coordinate equipment maintenance, calibration , and validation with appropriate internal departments.Perform review ... and revision of SOPs and master batch record instructions to improve operational accuracy and efficiency.Execute SAP transactions in a commercial environment.Support in troubleshooting product and equipment issues and deviations.Assist in providing timely… more
- Insmed Incorporated (Bridgewater, NJ)
- …laboratory and will be responsible for defining, leading, and managing calibration function. These responsibilities include running the day-to-day operations of the ... laboratory including equipment qualification and maintenance. The Manager will also serve as business owner for all computerized systems and will serve an active role in CSV activities including, but not limited to, review and approval of relevant CSV… more
- Novo Nordisk Inc. (Boulder, CO)
- …support manufacturing; UV-vis, KF, HPLC, GC, LC-MS, Endotoxin, etc. Knowledge of calibration and routine maintenance of instrumentation used in the analytical lab ... Ability to prepare and analyze samples accurately Keep accurate records in accordance with GDP, process data and provide detailed results for manufacturing Conduct laboratory work in safe, efficient manner Ability to complete sample analyses in an efficient,… more
- Merck & Co. (Rahway, NJ)
- …system, programmable logic controllers).Maintenance equipment (eg, tools and calibration equipment).Interact with vendors and support project coordination ... activities.Actively promotes safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates.Provides training to others, as necessary.Completes written documentation of work performed.Executes SAP… more
- BioAgilytix (Durham, NC)
- …dirty glassware if neededChecks for expired reagents and consumables Escorts/helps biohazard, calibration , and other service vendors. Ensures lab coats and PPE are ... stocked for use Sets up, maintains, troubleshoots general laboratoryequipment.Assists in the generation, revision, and/or review of laboratory or equipment-related SOPs and other qualitydocumentsAssists with defrosts of -20; De-ice of -80(as… more
- Catalent (St. Petersburg, FL)
- …material evaluation process for new materials. Shares responsibility for the routine calibration / standardization of analytical equipment such as, but not limited ... to balances, pH meters, KF titrators, AA, IR, UV/VIS, etc.Provides project support (wet chemistry and instrumental testing) for new product development.Additional duties as assigned.The CandidateAssociate in Science (AS) degree in scientific field with 5+… more
- Merck & Co. (Rahway, NJ)
- …GxP systems in the facility: Change Management, Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems.-Integration ... of control systems with MES, Quality, and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Develop and maintain SDLC documentation.Actively work in a… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to quality assurance, quality control, operations, engineering, maintenance, calibration , safety, supplier quality, technical services, subject matter experts, ... and quality approvers to ensure appropriate and timely determination of scope, potential product impact, root cause, and corrective and/or preventive actionsAuthor and manage several investigations simultaneously to meet key timing commitments, with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and oversee changes within quality systems.Assure equipment maintenance and calibration , and internal audits are performed.Prepare SOPs and specifications. Write ... memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation.Successful completion of all assigned training plans with demonstrated competence.This position may be involved with the transportation and… more
- Tris Pharma (Monmouth Junction, NJ)
- …stability (ST) sample testing and analytical instrumentation maintenance and calibration . ESSENTIAL FUNCTIONS Carries out responsibilities in accordance with company ... policies, Standard Operating Procedures (SOPs) and state, federal and local laws Creates, reviews or revises SOPs, methods, specifications, verification protocols, reports and change control requests, as needed; Performs vendor qualification for raw materials… more
- Catalent (St. Petersburg, FL)
- …validation and cleaning validation documents; d) all Preventive Maintenance and Calibration workThe Role Primary quality liaison for clients and internal customers. ... Is expected to become the Subject Matter Expert for the client products, processes and requirements. Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus. Effective coordination of functions across the… more
- Catalent (San Diego, CA)
- …samples and approve the respective specification of raw materials.Review calibration , validation and preventative maintenance certificates of laboratory and ... manufacturing equipment.Point person for safety complaints and improvements in the Quality Assurance Department using the Intelex software for logging complaints.EDUCATION AND EXPERIENCE: Requires a Bachelor's degree in Biotechnology or Related Field and 2… more
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