- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... risks involved in processing steps related to equipment, facility/utility and computer systems validation . This role will help develop and/or review… 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 ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Merck (Rahway, NJ)
- …the EMEA / AP or US region. **Primary Responsibilities:** + Delivery of best-in-class computer systems validation to capital projects. + Drive the adoption ... colleagues and coordinate activities across sites. + Ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC),… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.… more
- PCI Pharma Services (Bedford, NH)
- …team. In this role, you'll take the lead in developing and executing validation strategies for GxP computer systems -ensuring everything from equipment ... highest regulatory and performance standards. **What You'll Do:** + Lead validation activities throughout the computer system lifecycle-including plans,… more
- Charles River Laboratories (Wayne, PA)
- …RESPONSIBILITIES: + Write / assist in the preparation of clear and concise validation deliverables for computerized systems , including Validation Plans, ... in the writing of SOPs as they pertain to computer system validation and data integrity. +...11, and Annex 11 as they pertain to computerized systems , is preferred. + Familiarity of Good Manufacturing Practices… more
- Curia (Rensselaer, NY)
- …of five (5) years' relevant experience working in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP ... Curia Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV … more
- Kedrion Biopharma (Melville, NY)
- …EU, and GAMP 5 standards._ **_Job Role and Responsibilities_** + _Lead validation projects for GxP systems -authoring and executing protocols and documentation ... _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join our team and play... validation plans, traceability matrices, etc.)_ + _Ensure systems comply with all regulatory standards and industry best… more
- Astrix Technology (Atlanta, GA)
- …Bachelor's in chemistry or related field.Must have 2 years' experience with computer systems validation within the pharmaceutical or chemical ... for proposals. Lead Validation Projects and manage the validation lifecycle of computer systems , including planning, executing, and documenting … more
- PCI Pharma Services (Philadelphia, PA)
- …instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . ** Computer Validation Focus:** _Associate's Degree in ... to pioneer and shape the future of PCI. The ** Validation Analyst II** is responsible for overall validation... computer tasks and have some experience with computer systems considered to have an impact… more