- PCI Pharma Services (Rockford, IL)
- …across multiple value streams. You'll collaborate with internal stakeholders across Engineering, Quality , Validation , Operations, and Sales to ensure the success ... and manage change control processes. - Ensure strict adherence to all cGMP and FDA regulations and internal quality systems. **Required Qualifications**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and EH&S to ensure utility systems operate within validated parameters and comply with cGMP , FDA regulations, and company safety & quality standards. + Ensure ... Energy Manager (CEM). + Experience with commissioning, qualification, and validation of utility systems. + Experience leading deviation investigation, root cause… more
- Novo Nordisk (Clayton, NC)
- About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in ... to embark on the opportunity to help improve the quality of life for millions of people around the...equipment to achieve production goals. Relationships Reports to Shift Manager , Operations - API. Essential Functions + Work in… more
- TAI (Rockville, MD)
- …and quality standards. + Conducting risk assessments and process validation . + Implementing process automation and control systems. + Performing troubleshooting ... with Lean Manufacturing and Six Sigma methodologies. + Understanding of process validation and quality control. + Understanding of pharmaceutical safety… more
- Actalent (Kalamazoo, MI)
- …Lead Program Manager , Director of Engineering, and a couple of Quality Engineers. The company is a West Michigan-based medical device contract manufacturer with ... Engineer will play a vital role in ensuring efficient and high- quality production processes. This position involves equipment qualification, process validations, and… more
- PCI Pharma Services (Philadelphia, PA)
- …ll Location: Philadelphia, PA Department: Operations Shift: 1st Shift Reporting To: Sr Manager , Process Engineering The Process Engineer II role is focused on floor ... operations and eliminating waste to ensure a high- quality product is produced in a safe manner. The...Tests). + Responsible for determining OQ parameters to start validation . + Approves validation protocols and MPI's.… more
- Hovione (East Windsor, NJ)
- …accuracy of the data in compliance with legislation and regulatory standards of Quality , HSE and cGMP policies. Promotes the scientific excellence and innovation ... and new analytical methodologies - Coordinate priorities with Area responsible and Project manager to ensure that the timelines of the analytical work (such as… more
- Unither Pharmaceuticals (Rochester, NY)
- …in cGMP environment *Proven success in method development and validation SPECIFIC SKILLS: *Statistical data evaluation to include experimental design a plus. ... role Reporting to the Lead Development Chemist, JOB SUMMARY: Performs method validation and development from design to execution independent of supervision. Manages… more
- Fujifilm (College Station, TX)
- …used in P&IDs, blueprints, and architectural drawings. . Ensure compliance with internal quality protocols, SOPs, cGMP , and FDA guidelines. . Collaborate with ... **Position Overview** The CAD Specialist, guided by the Principal Engineering Manager -Engineering Projects, is tasked with enhancing the CAD function and defining… more
- Medtronic (Charlotte, NC)
- …exhausted. This activity may include travel to sites to perform both system repair, validation , and data gathering + Validation of warranty claim submissions and ... to RAS service activities + Active participation in RAS quality system. Function as a liaison between service team...engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable skills in Microsoft… more