- Fujifilm (Holly Springs, NC)
- …and executing Cleaning Validation (CV) activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 ... Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the… more
- ThermoFisher Scientific (Greenville, NC)
- …in providing technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations. This ... interpreting regulatory requirements and establishing systems. + Makes decisions on compliance issues within facilities, equipment, manufacturing , and support… more
- ThermoFisher Scientific (Greenville, NC)
- …leadership required. + Deep knowledge of cGMPs and pharmaceutical contract manufacturing , Quality Assurance, Compliance , Quality Control and Regulatory Affairs. ... First Shift (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** **GROUP/DIVISION… more
- Fujifilm (Research Triangle Park, NC)
- …Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance * Assists management with technical ... routine microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and… more
- Fujifilm (Holly Springs, NC)
- …Maintains accurate maintenance records and documentation + Follows SOPs to ensure compliance with safety and Good Manufacturing Practices (GMP) quality standards ... Ensure these systems meet the stringent requirements of pharmaceutical manufacturing . Also responsible for conducting regular inspections and preventive maintenance… more
- Fujifilm (Holly Springs, NC)
- …projects + Follows standard operating procedures (SOPs) and protocols to ensure compliance with safety and Good Manufacturing Practices (cGMP) quality standards ... Ensure these systems meet the stringent requirements of pharmaceutical manufacturing . Also responsible for conducting regular inspections and preventive maintenance… more
- Pfizer (Sanford, NC)
- …process evaluation, process mapping and site fit gap analysis and capturing manufacturing , automation, and compliance requirements + Develop and increase your ... MES Engineer supports developing and maintaining eMBRs at the Sanford, NC Manufacturing Site. Will become proficient with authoring in PharmaSuite MES. MES Engineer… more
- Fujifilm (Holly Springs, NC)
- …cause investigations *Follows standard operating procedures (SOPs) and protocols to ensure compliance with safety and Good Manufacturing Practices (cGMP) quality ... (SOPs), completes work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical… more
- Merck (Wilson, NC)
- …Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Manufacturing Process Validation, Regulatory Compliance , Root Cause Analysis ... Sr. Specialist, Engineering. This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including Drug… more
- Merck (Wilson, NC)
- …Innovation, Interpersonal Relationships, Lean Manufacturing , Management Process, Manufacturing Scale-Up, Regulatory Compliance , Root Cause Analysis (RCA), ... Assoc. Director, Engineering. This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including Drug… more