- Cognizant (Boston, MA)
- **About the role** As a ** Validation & Testing Lead in Life Sciences** , you will make an impact by driving the validation and testing strategy for Document ... to have to be considered:** + Deep knowledge of GxP regulations and global compliance standards (eg, 21 CFR...handling, CAPA management, and process harmonization. + Ability to lead cross-functional teams and manage validation deliverables… more
- Bristol Myers Squibb (Indianapolis, IN)
- …global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio's ... **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams. + Ensure RayzeBio computer… more
- Nestle (Bohemia, NY)
- …to business stakeholders. Your will be responsible for the selection, development, validation and maintenance of enterprise GxP systems, including but not ... and manage them through the IT governance process, drive the planning, implementation, validation and support of enterprise GxP applications. If you are… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- Job Title Lead Validation Eng Requisition JR000015194 ...OQ, PQ, and PV + Review and approval of validation documents including but not limited to: GxP ... (Open) Location St. Louis, MO Additional Locations Job Description Summary The Lead Validation Engineer will create, review and/or execute primary qualification… more
- Cognizant (Boston, MA)
- **About the role** As an **ALM** ** Validation Lead ** , you will make an impact by leading validation and testing initiatives across life sciences systems, ... and test strategies aligned with FDA, EMA, and GxP standards, supporting the transition to CSA. + Define...a focus on digital transformation and paperless execution. + Lead end-to-end validation and testing phases for… more
- Cognizant (Boston, MA)
- **About the role** **As an MES Validation Lead ,** you will make an impact by driving Computer System Validation (CSV) initiatives within the Life Sciences ... and business units. **In this role, you will:** * Lead validation strategy and execution for Document...to have to be considered:** * Deep knowledge of GxP regulations and global compliance standards (eg, 21 CFR… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Computer System Validation Requisition ID: 71527 Date: Oct 3, 2025 Location: Exton, Pennsylvania, US Department: Laboratory Description: **This is ... leading the documentation for equipment that requires a computer system validation approach. You will collaborate with internal stakeholders (Quality Assurance (QA),… more
- Bristol Myers Squibb (Devens, MA)
- …qualification testing documents and associated testing deviations, providing escalations to CSV Lead as appropriate. + Review and approve validation lifecycle ... skilled and motivated Senior Engineer - IT Computer System Validation (CSV) to join our team at the Devens...reports for computer systems and software applications used in GxP environments. + Act as CSV Subject Matter Expert… more
- Jabil (Hunt Valley, MD)
- …initiatives. + Provide strategic input on new facility and equipment design to ensure validation readiness. + Lead validation readiness for tech transfers, ... vibrant and diverse communities around the globe. Job Summary: The Director of Validation will lead all validation activities across pharmaceutical and… more
- NTT DATA North America (Highland Heights, KY)
- …11, along with strong leadership and cross-functional collaboration skills. Key Responsibilities: Validation Planning & Execution Lead and execute validation ... Design and implement integration, regression, and performance testing strategies. Oversee validation execution in GxP facilities, ensuring compliance with SOPs… more
- Boehringer Ingelheim (Athens, GA)
- …validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's ... and requirements and are suitable for their intended purposes. The Principal Specialist, Validation will lead project management efforts for validation … more
- Sokol Materials & Services (Skillman, NJ)
- QA Lead Technical Operations - CAPA Job Location Devens,...Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product ... * Review and approve documents related to Quality, Quality Control, Validation , and Automation. * Review and approve Standard Operating Procedures (SOPs).… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …an automation lead within a specific area, or be the automation validation lead for medium/small scale automation projects. The Senior Automation Engineer II ... teams. + Capable of adhering to Good Manufacturing Practices ( GxP ) - Compliance, Change Control, Quality Oversight, Validation... within a specific area, or be the automation validation lead for large scale automation projects.… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …visionary leader to serve as the Executive Director of Digital Quality. The incumbent will lead a team of over 30 highly technical digital and AI experts that will ... Product Development functions. The ideal candidate will bring deep expertise in GxP digital systems, regulatory compliance, and agile innovation, along with a proven… more
- Bristol Myers Squibb (Princeton, NJ)
- …continuous improvement. + Ensure hands-on leadership in data privacy, cybersecurity frameworks, GxP validation , and risk management for regulated environments. + ... more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager, Technical Lead / Solution Architect combines strategic solution design with… more
- Sokol Materials & Services (Skillman, NJ)
- …industry. + Experience in cell therapy/biologic/vaccine manufacturing support, tech transfer, and validation . + Design and execute test plans and other risk ... + Support Clinical Production Activities. + Experience with the start-up, validation , and licensure of new biopharmaceutical manufacturing facilities. + Basic… more
- Lilly (Lebanon, IN)
- …**What You Will Be Doing:** The purpose of the Application Support lead is to provide leadership and oversight of the MES(Manufacturing Execution System). ... critical system within the LP2 Manufacturing space. The Application Support lead will have responsibility over application services including multi-tiered support,… more
- Abbott (Alameda, CA)
- …ensure manufacturing tests are adequate *Reviews and contributes to test method validation protocols *Specifies and develops test fixtures for PCBA functional test, ... process/product requirements and design specifications. + Equipment/facility/process commissioning and validation required + Working on a development team with an… more
- Genentech (Louisville, KY)
- …final steps before products can be delivered to patients. The Quality Site Lead manages the Quality team at KDC, Genentech's North American logistics and ... objectives. * Manage a team of approximately 5-10 members, responsible for GxP quality oversight, inspection readiness, early escalation of compliance gaps and… more
- Kelly Services (Somerset, NJ)
- …is responsible for providing hands-on analytical support for method development, validation , and transfer activities within the Analytical R&D team, with minimal ... supervision. This role may also serve as a project lead , overseeing analytical method optimization, evaluation, and stability studies using a range of laboratory… more