- Cipla (Hauppauge, NY)
- …The incumbent to this role performs and oversees cGMP compliance-based services ( commissioning , qualification , validation , consulting, etc.) on equipment and ... working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY… more
- Merck & Co. (Rahway, NJ)
- …off shift work may be required to meet project, operations, and qualification needs.Execute and develop appropriate system validation , change control, and ... is advantageous-Working experience with GAMP, S88 and other industry standards. Commissioning and qualification test protocol development and execution-Track… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …all engineering management including asset/reliability, data systems/automation and Commissioning / Qualification .Support the development and implementation of ... business objectives.Manage and mentor a high-performing team of engineering and commissioning / qualification professionals.Ensure compliance with all applicable… more
- Cognizant (Wilson, NC)
- **Job Summary:** The Sr/Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems ... regulated manufacturing site. This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals, while… more
- Amgen (Holly Springs, NC)
- …waste, as part of Amgen's plan to be a carbon-neutral company by 2027. ** Senior Engineer** **- Commissioning and Qualification Engineering Lead** **What you ... **Basic Qualifications:** + High school diploma / GED and 12 years of Commissioning , Qualification , and Validation experience OR + Associate's degree and 10… more
- Stantec (Cleveland, OH)
- …distributed, including computerized and automated systems which require qualification and validation for compliance. The commissioning and validation of ... life the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities… more
- AbbVie (Worcester, MA)
- …and other project team members to plan, and complete tasks associated with commissioning , qualification and validation of new and modified equipment, ... design based on FMEA or other risk assessment. + Develop and execute commissioning , qualification and validation test protocols to ensure that the unit… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …Design Qualification , Commissioning and Qualification , Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. ... is true to the best of my knowledge. **Job Description** **About the role:** As Senior Validation Engineer, you will support the operations through the initial … more
- Amgen (Holly Springs, NC)
- …projects. + Perform quality review and approval of documents to support facility commissioning and qualification , Validation Protocols, Validation ... Air Systems + Pharmaceutical Grade Compressed Gasses + Experience/knowledge in commissioning / qualification / validation , including utility systems and cleaning… more
- PACIV (Indianapolis, IN)
- …testing protocols, and final reports. + Proficient in Commissioning & Qualification (C&Q) and/or Computer System Validation (CSV), with a solid understanding ... regulated environments. Join our Indianapolis, IN team as a Senior Validation Project Lead and take ownership...Technical Responsibilities + Serve as a custodian of the Commissioning and Qualification (C&Q) process by adhering… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- … commissioning , owner interaction, qualifications **Knowledge, Skills & Abilities:** ** Senior Automation Engineer I - Validation :** **System Technical ... in more than 110 countries and regions. **Location: Clayton** **Sr. Automation Engineer I - Validation ** The Senior Automation Engineer I is a senior level… more
- Bristol Myers Squibb (Indianapolis, IN)
- …This role is responsible for the development, execution, and management of commissioning , qualification , and validation (CQV) documents and protocols ... to be the global leader in radiopharmaceuticals. **Summary** The Senior Validation Engineer will lead validation...as validation subject matter expert for the commissioning and qualification of a 60,000 sq.… more
- Amgen (Holly Springs, NC)
- … Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols/reports, and cleaning ... evaluations, and development. + Coordinate troubleshooting and support during commissioning , qualification , start-up, and process performance qualification… more
- Jabil (Hunt Valley, MD)
- …(QMS) oversight, audit, inspection follow-up (CAPA), and support readiness activities for validation . + Collaborate with senior validation leadership, ... cGMP, FDA, EMA (Annex 1), and other global regulatory requirements for validation and qualification . + Collaborate with Engineering, Quality Assurance,… more
- J&J Family of Companies (Titusville, NJ)
- …this role is the key point of contact for all technical matters related to Commissioning , Qualification & Validation . The CAR-T (CQV) Lead is responsible for ... at the site level and beyond, with a focus on Commissioning , Qualification , Re- qualification , and Validation within the JJIM CAR-T facilities. The… more
- Lilly (Lebanon, IN)
- …Mentor process control team, including design, controls philosophy, implementation and commissioning * Process control validation testing, implementation and ... make life better for people around the world. The Senior Principal Engineer - Automation Engineering will work as... and data integrity * Experience in design, development, commissioning and qualification of highly automated greenfield… more
- Lilly (Indianapolis, IN)
- …and other site projects. **Job Responsibilities:** + Define and drive the ** Commissioning , Qualification and Validation (CQV) strategy** and leadership ... operational readiness. This includes: + ** Qualification and Validation Activities** : FAT, commissioning , and validation of equipment and workflows. +… more
- Lilly (Indianapolis, IN)
- …facilitate the transition from construction to operational readiness, including facility qualification , equipment validation , and staff training. + Implement ... + Experience in Project Management during Tech Transfer, design, development, commissioning and qualification of highly automated greenfield manufacturing sites… more
- Genentech (Los Angeles, CA)
- …guidelines. + Automation lead for equipment/software FAT, field testing and commissioning + Provide scope, qualification , resource, and budget estimates ... Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). **The Opportunity** A Senior Principal ITOT Infrastructure Engineer is being hired to… more
- US Tech Solutions (Thousand Oaks, CA)
- …good documentation and safety compliant practices. + Ensure safety during commissioning , validation , maintenance and manufacturing activities + Support ... for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports… more
