- Exela Pharma Sciences, LLC (Lenoir, NC)
- …requirements for validationDevelop and implement strategies for equipment IQ/OQ/PQ, process validation , computer system validation and calibrationPerform ... Position Summary:Oversee and lead the validation program for production equipment and processes used...manufacturing of aseptic and terminally sterilized products. Lead the validation team in the establishment and maintenance of validated… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Catalent (St. Petersburg, FL)
- …total relevant experience will be considered.Pharmaceutical and/or life sciences experience including Computer System Validation , 21 CFR Part 11 and general GxP ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- BioAgilytix (Durham, NC)
- …revenue recognition activities, database systems, and resource planningSupport Validation and Sample Analysis ProjectsEnsure great customer experienceSupport ... moving) objects, including laboratory samples, laboratory equipment, and laptop computer , with a maximum lift of 30 poundsAbility to...as -80°CAbility to access and use a variety of computer software Ability to communicate information and ideas so… more
- Novo Nordisk Inc. (Durham, NC)
- …validation requirements including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts is required ... support is on site as needed during production activities Coordinate all validation /transfer activities involving MDev support Lead team in successful execution of… more
- Merck & Co. (Durham, NC)
- …Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control ... (eg tools and calibration equipment)Assist with execution of calibration, automation, validation and additional testing, as requiredDecisions are guided by policies,… more
- Aequor (Libertyville, IL)
- …success working in a high-performing, business results-driven environment. Understanding of computer system validation . Familiarity with ERP systems (ie SAP ... a plus. Education and Experience: Bachelor's degree in an engineering or computer management discipline. Must have experience with Manufacturing IT Systems and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Supervisor of IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems: Drive and maintain IT Operations ... needs Acts as IT Operations advocate, coordinating daily activities with the IT Manager (IT Infrastructure Owner) and team members Assists the IT Operations Partner… more
- Cook Medical (Pittsburgh, PA)
- …motivated by helping others, and driven by integrity, we invite you to apply. The Computer System Validation Manager at Cook MyoSite, Inc. manages ... applications, IT infrastructure, and computer system hardware. The Computer System Validation Manager works with management, especially the Computer… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation… more
- Microsoft Corporation (Redmond, WA)
- …can thrive at work and beyond. **Responsibilities** As a Principal Software Engineer Manager - Hardware & Operating Systems Validation , you will be responsible ... the Engineering Systems organization which provides build, quality and validation capabilities for. Our team is engaged in an...for the following: + As a manager , deliver success through empowerment and accountability by modeling,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Manager , QA Validation Department: QA Validation Location: Monroe, NC START YOUR APPLICATION ... as a leading integrated research-based pharmaceutical company. POSITION SUMMARY : The Manager , QA Validation is responsible for providing leadership and… more
- Catalent Pharma Solutions (Bloomington, IN)
- …and requirements of company policies and FDA regulations. **The Process Validation Manager 's responsibilities include managing multiple projects to provide ... from FDA, EMA, PDA, ISPE, and other industry organizations + Understands validation technical disciplines, including equipment, cleaning, computer system … more
- Bristol Myers Squibb (Bothell, WA)
- … validation in a biopharmaceutical environment. + Experience in use of computer systems related to validation , calibration, maintenance, change control, and ... relevant GMP operations experience. + A minimum of 5 years of equipment qualification or computer systems validation experience. + A minimum of 5 years of direct… more
- ThermoFisher Scientific (Greenville, NC)
- **Job Description** ** Manager , Validation ** **Position Summary** Lead a professional support staff and contractors responsible for validation of all products ... manufacturing equipment, utility systems, facilities, and manufacturing processes and computer /information./automation validation . + Develop, approve, implement, and… more
- Bristol Myers Squibb (Devens, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The Manager , Sr. Validation Engineer I supports the successful implementation of ... Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and… more
- HP Inc. (Boise, ID)
- …responsible for leading managers and individual contributors responsible for Enterprise System Validation . This team is located in Boise, Korea, and India and ... quality during development, engaging with multiple stakeholders for managing validation activities, and identifying process improvement and cost reduction… more
- PCI Pharma Services (Rockford, IL)
- …configuration, and fundamentals of heating, air conditioning, and refrigeration systems. + Computer Validation Focus: Ability to perform complex computer ... configuration, and fundamentals of heating, air conditioning, and refrigeration systems. + Computer Validation Focus: Ability to perform complex computer … more
- PCI Pharma Services (Rockford, IL)
- …configuration, and fundamentals of heating, air conditioning, and refrigeration systems. + Computer Validation Focus: Ability to perform complex computer ... conference calls and meetings. Effectively communicates project goals and progress to Validation Supervisor / Manager . + Investigates validation deviations,… more
