Performs tasks in support of the pharmaceutical manufacturing processes in Manufacturing. Specific requirements include authoring and revising of documents, authoring training materials, and The position provides oversight, execution, and approval for transactions in QAD as well as ensuring that OEE performance data is collected as specified for each operating area. Techn

Member of the Process Engineering team and perform the functions of a Responsible System Engineer (RSE) Seek for time or money saving efforts in production processes or utility systems Responsible for generating room equipment layout and utility assessment for Projects Technical lead for any issues which may arise in the cleanroom infrastructure and related utilities Resp

Organize, plan, execute and lead the activities of the site calibration function by providing technical, quality, compliance and safety leadership to calibration, preventive maintenance, and re qualification related tasks. Lead calibration, pressure balancing, and recertification of biosafety cabinets, laminar flow hoods, HEPA filters, and perform static and dynamic air f

Lead the design, development, installation, validation, set up and maintenance of Process and Building Automation Systems in a regulated GMP environment. Mobilize and adapt automation systems for various manufacturing projects including connection of portable and fixed equipment to the Production Network, SCADA, Databases, and Historians for the purposes of collecting, ar

Lead periodic reviews, re qualifications, and re validations for FUSE (Facilities, Utilities, Systems and Equipment), QC Analytical Instruments, or any other required areas. Support/lead CQV Commissioning, Qualification and Validation effort for multiple areas of Ology Bioservices equipment and computer systems. Demonstrate working knowledge of FDA regulations, USP 1058,

The Sterility Assurance Lead is accountable for assisting in the development and oversight of the implementation of the microbial contamination control and viral safety programs at Resilience. This is an exciting opportunity to contribute to the establishment of a robust and comprehensive contamination control program. The Sterility Assurance Lead will collaborate with mu

Member of the Engineering Dept and perform the functions of a Responsible System Engineer (RSE) for assigned systems. Lead, plan and execute the design, installation, qualification, operation, maintenance, and continuous improvement of mechanical systems as applied to BioPharma manufacturing facility (e.g. HVAC systems, Boilers, Heat exchangers, Compressors, Processes ves

This Sr. Manager, Sales & Business Development (Remote Southeast) role is responsible for growing the Emerging Modalities (Cell, Gene, and Nucleic Acids) business in the Southeast US and is accountable for results in a dynamic and fast paced environment to drive sales volume and profitable revenue for the Emerging Modalities Franchise across our technology platforms; Proc

The Sr. Managerof Health, Safety, and Environment (HSE) is responsible for providing HSE technical and regulatory support to the Alachua, Florida operational campus which includes the Advanced Development and Manufacturing (ADM) facility, the ADM Expansion Building and the Process Development Laboratory Building. Responsible for the implementation of all necessary measure

The Project Manager (PM) is responsible for the on site planning, oversight and execution of all project related tasks and activities required to fulfill contracted scope and to satisfy the expectations of the company and its clients. This role is essential to successfully executing projects in support of company franchises and modalities, to include coordinating a matrix

Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment. Advisory and support of application owners to build and maintain GxP conforming systems and ensure compliance with applicable regulations and industry standards. Implementation of qualification/validation requirements for new and existing computer systems. Development an