- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... for supporting qualification of Fermentation Process Automation at our Company's Durham, NC facility. Responsibilities include:- supporting commissioning and… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Specialist , Manufacturing Automation (Hybrid) g, quality and engineering groups.- -Supports a large spectrum of sophisticated ... within Manufacturing Operations; providing multiple opportunities to learn new automatioThe Specialist is a member of the Focus Factory Automation team responsible… more
- Merck & Co. (Rahway, NJ)
- …job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position will report to the Director, Engineering, ... production, utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing Automation include the following:Site Operations (GWES)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …records, reports) associated with technical operations, production, engineering, and validation Incorporate technical pre-planned process improvements and cost ... support technical operations. Assists in coordination and execution of process and equipment improvement programs, investigates deviations, and implements… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a CQV Specialist (Contract Position) as part of the Technical Operations team based in Raritan, ... This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing… more
- Merck & Co. (Durham, NC)
- …and humidity) during processingReview incursions into classified areas for process and environmental impact and approve accordinglyConduct periodic shop floor ... and reviewDirect support of regulatory inspections and auditsDirect support of validation activities and all other associated quality functionsOther duties as… more
- Novo Nordisk Inc. (Durham, NC)
- …conjunction with LoB). Performs archiving duties and QA presence & process confirmation on shop floor. Relationships Manager, Quality Assurance. Essential Functions ... other documentation Supports & reviews investigations & root-cause analysis Participates in process confirmations & Go Look Sees Follow all safety & environmental… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the daily task of chargebacks errors to ensure that the Chargebacks Team will process and validate each line to as to avoid deductions from Trading Partners Develop ... and resolve entity eligibility through research of various databases Owns the process of membership list maintenance for selected commercial and government GPOs,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Review and assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses deviations; includes tracking, follow-up and ... with flexibility for changes in work priorities We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports ... data requires evaluation of identifiable factors We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo… more
- Aequor (Thousand Oaks, CA)
- …or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. processes. c) Approve ... and experience with processes involved in manufacturing and distribution, QA, QAL, validation , and process development. Strong communication (both written and… more
- BioAgilytix (Boston, MA)
- …of a traditional lab analyst, peer reviewer, and new system implementation specialist . Tasks will encompass running assays, reviewing data, and devising and ... objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … improvement and implementation of new manufacturing technologies. Ensure successful manufacturing process comparability and process validation runs by ... Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy...and expertise of cell and gene therapy processes and/or process technologies. They will also oversee processes and standards… more
- Boehringer Ingelheim (St. Joseph, MO)
- … validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's ... activities at the BIAH US locations from concept through process validation as outlined by BIAH's ...software (MS-Word, MS-Excel, MS-Outlook, PowerPoint). **Requirements for a Sr. Specialist Validation ** + A BS degree from… more
- Regeneron Pharmaceuticals (Troy, NY)
- …company manufacturing standards policies and procedures. The day to day of a QA Validation Specialist could include, but are not limited to, the following: + ... of relevant experience for each level: + Associate QA Validation Specialist : 0 - 2 years...certain background checks will form part of the recruitment process . Background checks will be conducted in accordance with… more
- PCI Pharma Services (Philadelphia, PA)
- …execution of packaging equipment qualification protocols, generation and execution of process validation protocols, assistance in customer audits, and ... the following but other duties may be assigned. A Validation Specialist is expected to lead the...(SAT) to qualify equipment. Assist in the Change Control process (TrackWise) Coordinate validation efforts with mechanics,… more
- Unither Pharmaceuticals (Rochester, NY)
- Validation Specialist Who we are? We...generated by validation studies performed by the Validation group to determine process capabilities. Gathers ... validation / qualification activities are maintained according to procedure. Process Improvements (20%) Keeps abreast of industry current practices, and modifies… more
- United Therapeutics (Silver Spring, MD)
- …diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently ... teams, including developing and reviewing protocols and final reports, representing validation on project teams, and preparing validation change control… more
- Regeneron Pharmaceuticals (Troy, NY)
- …manufacturing standards policies and procedures. The day to day of an Associate QA Validation Specialist could include, but are not limited to, the following: + ... of relevant experience for each level: + Assoc. QA Validation Specialist : 0 - 2 years...certain background checks will form part of the recruitment process . Background checks will be conducted in accordance with… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … department at Regeneron is adding to their team! The **Associate** **QA Validation Specialist - External Partners** coordinates the equipment, systems, and ... following minimum amounts of experience required for each level: + Associate QA Validation Specialist : 0-2 years May substitute proven experience for education… more
