- Bristol Myers Squibb (Indianapolis, IN)
- …Qualifications * Expertise in pharmaceutical engineering, including cGMP and FDA /USP/OSHA regulatory requirements. * Proven experience developing and leading ... * In-depth knowledge and hands-on experience with radiopharmaceutical production, and related GMP facility site builds is desired. * Strong background in facility… more
- Catalent Pharma Solutions (Greendale, IN)
- …(HACCP), Food Quality Plan (FQP) standards. Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training. + ... English. Ability to communicate with all line level positions and management. + Knowledge of GMP and Quality systems. + The employee must be able to lift and/or move… more
- Cardinal Health (Indianapolis, IN)
- …preferred + At least 2 years of experience working with 21CFR 210, 211 in the FDA regulated industry + Must work well with others and understand how to be successful ... in a team environment + Experience with GMP preferred + Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated + Must be… more
- ThermoFisher Scientific (Indianapolis, IN)
- …(Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** **Job Title: Senior Manager, ... Ensure platform compliance with healthcare regulations including HIPAA, CLIA, IVDR, FDA , and GLP. + Work cross-functionally with product management, R&D, Commercial,… more
- Novo Nordisk (Bloomington, IN)
- …guidelines + Recommend facility improvements to meet OSHA safety, ISPE, or FDA guidelines and improve efficiency + Create maintenance procedures and update existing ... + Knowledge of PLC programs and ladder logic is a plus + Knowledge of GMP regulations, 21 CFR parts 210 and 211, EU regulations and ISO Standards + Prior… more
- Novo Nordisk (Bloomington, IN)
- …resolve equipment and/or process problems in a timely manner, creating and revising GMP as it relates to equipment activities, supporting or owning work orders and ... system + Recommend facility improvements to meet OSHA safety, ISPE, or FDA guidelines + Opportunity to contribute on Safety Committee, Environmental Engagement… more
- Nestle (Anderson, IN)
- …and feedback process for projects. + Monitors processes for compliance with quality and GMP requirements in accordance with FDA and OSHA regulations. + Provide ... construction management and plant startup assistance as needed to ensure successful project execution + Evaluate, select, and issue contracts for construction firms through bidding and prequalification vetting processes. + Provide self-directed project… more
- Nestle (Anderson, IN)
- …and feedback process for projects. + Monitors processes for compliance with quality and GMP requirements in accordance with FDA and OSHA regulations. + Provide ... construction management and plant startup assistance as needed to ensure successful project execution + Evaluate, select, and issue contracts for construction firms through bidding and prequalification vetting processes. + Provide self-directed project… more
- Lilly (Indianapolis, IN)
- …Preferences:** + Solid Understanding of Basic Requirements of Regulatory Agencies Such as the FDA , EMEA, DEKRA, And Osha in a GMP environment. + Previous ... Experience with Highly Automated Equipment and OEM vendors as well as Industry leading Automation suppliers. + Previous Experience in Supporting Parenteral Manufacturing Operations. + Previous Equipment Qualification and Process Validation Experience. +… more
- Cardinal Health (Indianapolis, IN)
- …sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (ie FDA , NRC, DOT) to support patient treatment through disease diagnosis, ... preferred. + At least 2 years of experience working in a GMP manufacturing environment in the pharmaceutical or biotechnology industry preferred. + Demonstrated… more