Responsible for ensuring one technical process exists within the PET/Facility. This includes equipment, materials, process, and procedures with applicable validation. Leads improvement initiatives as the technical expert and acts as the first line of support for all project related work. Responsible for maintaining a strong relationship with Technical Operations and Quali

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

The Senior Manager, Quality Control Analytical will report to the Director of the Quality Control Analytical team at the Resilience Philadelphia site. This motivated and organized individual with strong people skills will provide supervision and technical expertise to the QC Analytical laboratory while maintaining open communication channels to meet the needs of the organ

Implement laboratory instrument systems with policies, standards, and procedures aligned with enterprise standards/templates. Deliver GxP validation planning and execution for on premises and enterprise systems deployments Design and implement procedures for the support and management of laboratory computers and devices Ensure the secure connection of our systems, whether

The Director, Sterility Assurance is accountable for developing and overseeing the implementation of the contamination control program at Resilience. This is an exciting opportunity to contribute to maintain a robust and comprehensive program. The Director, Sterility Assurance will collaborate with multiple stakeholders to ensure the harmonized execution of contamination

The Manufacturing Technician III, (Packaging Mechanic) reports to a Supervisor or Manager on theManufacturing floor, which supports Packaging operations. The position entails the execution of setup,changeover, repairs, and preventative maintenance for all equipment used in the production processes in various Classified/Non Classified areas and performs the role of a Packa

The Quality Technician II, Aseptic Control should autonomously perform tasks related to environmental monitoring to support the regulatory requirements of a sterile manufacturing site. This position requires operating equipment in various classified / non classified areas up to a Class 100 aseptic environment and in a laboratory setting. Position Responsibilities Prepare

The Quality Technician II, Aseptic Control should autonomously perform tasks related to environmental monitoring to support the regulatory requirements of a sterile manufacturing site. This position requires operating equipment in various classified / non classified areas up to a Class 100 aseptic environment and in a laboratory setting. Position Responsibilities Prepare

Provide primary site technical support for the entire Tech Transfer process from initial evaluation to PPQ, including change control ownership, in compliance with site procedures. Define and own technical requirements for new equipment design specifications (URS) Develop and own site Control Strategy Documents for processes transferred Work with Project Managers to ensure

This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management

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