Computer System Validation Engineer

Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana. Roles & Responsibilities: Execute and manage com

Direct W2 contractors only! No 3rd party agencies! This is a 100 % remote role. Candidates must be located within the USA. Duration: 12 months The Hillsboro Innovative Therapies (HIT) team is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies. As a member of our Manufacturing Execution System (MES) team, you will have the

Direct hire /Full time On-site Boulder, CO Salary expectation: You povide Summary We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations. This role requires hands-on technical expertis

Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Lead the authoring and executing of protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results. In addition, this role will coach and assist Pharma Validation Engineers throu