and consulting solutions. At PCI, calibrations are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable...
to stakeholders and clients. Lead cross-functional Operational Readiness teams in both internal and consulting environments. Possess..., Regulatory or related discipline OR a combination of equivalent experience in quality assurance, cGMP facility start-up...
, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations... messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives...
, solvent recovery concepts) where they make valuable contributions Ensure API cGMP standards are applied consistently... Strong understanding of cGMP environments and regulatory expectations for API manufacturing across multiple end‑use modalities (e.g., APIs...
that all activities within bulk drug substance operations adhere to cGMP and other regulatory requirements. Key Responsibilities...), and Process Development Laboratories. Ensure facilities, equipment, materials, processes, and products comply with cGMP...
matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.... We are looking for a Senior Process Facilities Engineer to support an OTC cGMP Facility Relocation and Manufacturing Integration Project. The...
engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience. Years... of Experience: 1-5 years in consulting and/or engineering services Willingness to travel as required for client project...
, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience. Years of Experience: 0...-2 years in consulting and/or engineering services Willingness to travel up to 100% or as required for client projects...
expertise across HVAC, building mechanical systems, and plant utilities within a consulting environment. While the core of the... to validation. Ensure HVAC, mechanical, and utility systems comply with current Good Manufacturing Practices (cGMP). Develop...
matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry... in accordance with client procedures and cGMP, FDA, EMA, and other regulatory guidelines. Coordinate validation activities...