- Twist BioScience (South San Francisco, CA)
- …Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical challenges in the ... skills in SAS systems and application development and experience. The Associate Director must be a highly specialized individual contributor or functional manager… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical...from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is responsible for design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry - Required 4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - ... Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This… more
- Merck & Co. (Rahway, NJ)
- …equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly ... manufacturing (molding and assembly) is preferred but not required.Proficient in computer -aided design (CAD) and computer -aided engineering (CAE) software such… more
- Catalent Pharma Solutions (Harmans, MD)
- **Associate Director , Validation & Engineering** Catalent Pharma Solutions is looking to hire a **Associate Director , Validation & Engineering** to lead ... house 8 CGMP manufacturing suites and cold storage warehousing. The **Associate Director , Validation & Engineering** is responsible for the strategic leadership… more
- Comcast (Philadelphia, PA)
- …100 miles from the office for the remote option.) **Job Summary** The Director , Access Network Architecture, Validation and Automation, will work across ... **leadership** , **vision** and **direction** to a team ofSMEs working in validation , lab infrastructure, and automation roles in Access Network Engineering(ANE) as… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... this role, you will report directly to the Exec. Director , IT and be responsible to deliver on compliance...goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... through commercial production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems in alignment with… more
- Curia (Rensselaer, NY)
- …team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems Engineer ... functional areas across the organization to maintain and improve computer system validation processes to ensure robust,...Other duties as assigned by QA manager and/or QA director Education and Experience: + Bachelor's degree in Engineering,… more
- Northrop Grumman (Annapolis Junction, MD)
- …Polygraph **Preferred Qualifications for Staff Systems Engineer - Verification and Validation :** + Advanced Degrees in Electrical Engineering, Computer ... candidate for the position of **Staff Systems Engineer - Verification and Validation (V&V)** to support Advanced Technology development programs. This position will… more
- Lilly (Pleasant Prairie, WI)
- …that impact the site and align with corporate objectives. The Associate Director , Quality Assurance, will also provide computer system quality assurance ... of data management and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory compliance, consistency,… more
- LifePoint Health (Beckley, WV)
- …measure data prior to data release. Develops and maintains processes for data validation and integrity for selected projects. Utilizes computer hardware and ... regarding the planning and implementation of trauma services. Reports to the Director of Emergency and Trauma Services for Raleigh General Hospital. ESSENTIAL… more
- ThermoFisher Scientific (Indianapolis, IN)
- …you do:** + Lead and mentor a team of Quality professionals committed to computer systems compliance and validation of critical business systems. + Coordinate ... impact:** Reporting directly to the Vice President, Quality, the Director , Quality - Digital Systems Compliance is responsible for...all aspects of the company's Computer System Validation (CSV) and global IT… more
- Wells Fargo (Charlotte, NC)
- …of the model lifecycle. This includes identification, development, validation , implementation, usage, performance monitoring, documentation, and risk reporting ... model risk management across the lifecycle, including risk tiering, validation , performance monitoring, issue remediation, and compensating controls, in alignment… more
- PCI Pharma Services (Philadelphia, PA)
- …to pioneer and shape the future of PCI. **Position Summary:** The Director , Global HR/IT Applications is responsible for the strategic and operational leadership ... objectives, enhances user experience, and drives data integrity and security. The Director will be responsible for managing a small team and successful delivery… more
- J&J Family of Companies (Raritan, NJ)
- …infrastructure in accordance with J&J's Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the ... **Job Description:** Johnson and Johnson is hiring a JJTQ Director , Acquisition Divestiture in Raritan, NJ! At Johnson &...project progress and design issues + Strong experience in computer systems validation in GxP environments in… more
- Lilly (Durham, NC)
- …**Additional Preferences:** + Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation ... life better for people around the world. The Associate Director - Quality Engineering is responsible for demonstrating leadership,...+ Previous use of KNEAT - or other electronic validation software. + Previous computer system oversight.… more
- Lilly (Indianapolis, IN)
- …leadership across the different site and global IT groups focused on Computer System Validation Strategies, external regulations, industry best practices, ... outcomes efficiently and within budget. **How You'll Succeed:** + Oversight of computer systems validation strategies and activities across new API facilities,… more
