- Amgen (Holly Springs, NC)
- …**Responsibilities include but are not limited to:** + Support technology transfer, process validation , and plant start-up + Provide technical leadership in ... + In-depth expertise in biologics process purification processes + Experience in process scale-up, technology transfer, process validation , process … more
- Endo International (Raleigh, NC)
- …Skills/Qualifications:_ _Other Skills:_ _Competencies:_ Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing ... Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation . + Prepares periodic… more
- Genentech (Holly Springs, NC)
- …smart factory is desirable + Prior experience with technology transfers, process validation , authoring regulatory submissions, and Health Authority inspections ... Products). **The Opportunity:** We're seeking a highly experienced and strategic Process Engineering Lead to oversee all process design, qualification,… more
- Fujifilm (Holly Springs, NC)
- …in response to critical deviations + Leads the execution of all aspects of process validation including ancillary process validation (both at-scale ... (GMP) environment + Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and… more
- Synchrony (Charlotte, NC)
- …assurance and Capacity Planning** : Establish and maintain a quality assurance process to thoroughly review and assess validation practices. Proactively ... Job Description: **Role Summary/Purpose:** The VP, Fraud/GEN AI Validation COE is responsible for performing model ...the model governance team in designing the quality assurance process and leading the execution across all validations, act… more
- Fujifilm (Holly Springs, NC)
- …associated support functions such as Process Science, Engineering Science, Process Engineering, Validation , and Automation + Ensures the quality assurance ... standards + Approves critical lifecycle documentation, including risk assessments, product/ process /equipment specifications, functional specifications,traceability matrices, qualification protocols, validation… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …include activities such as scale-up batches, exhibit/registration batches, and process validation Batches. OVERALL JOB RESPONSIBILITIES Responsibilities Results ... science-based approach Engineering and/or scale-up batches, exhibit/registration batches and Process Validation Batches support in Manufacturing area. Cleaning… more
- Fujifilm (Holly Springs, NC)
- …investigations, studies and projects + Supports generation of sampling plans for process validation reports (PVRs) and investigations + Collaborates with the ... Requirements** + Prior drug substance or manufacturing experience, including process validation , transfer and commercialization, and manufacturing support… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …projects through lab scale or scale-up process /product development studies, product and process validation . 2. Assist in the analysis of process and ... The Process Engineer Intern will provide support on ongoing...potential failures and to aid in solving product and process problems 3. Perform a variety of testing using… more
- Insight Global (Browns Summit, NC)
- …will be directly supporting a large project and initiative for change management, process control & improvement, validation reporting, and program process ... Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements * Process Improvement, Change Management, and Validation experience.… more