Katalyst Healthcares & Life Sciences

Responsibilities:Select and evaluate suppliers by leading efforts to find new suppliers in an existing or new commodity.Conduct on-site supplier assessments as well as QMS audits and address the non-conformities.Work with suppliers and ISI engineering for the new product introduction More...

Responsibilities:Lead end-to-end NPI activities for embedded software testing in medical devices.Oversee Test protocols test strategy and test automation testing aligned with IEC 62304 standards.Manage and troubleshoot communication protocols including BLE Serial SPI UART.Utilize prot More...

Responsibilities:Develop implement and maintain software quality assurance processes for non-product software used in medical device development.Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software.Support audits and i More...

Responsibilities:Accurately document all testing activities maintain detailed data records manually and electronically and ensure compliance with documentation standards.Follow Good Laboratory Practices (GLP) and safety protocols to maintain a clean organized and safe working environm More...

Job Description:The Biotherapeutics and Genetic Medicine Group is seeking a highly motivated scientist for initiating the lentiviral delivery platform for gene therapy in a newly established Genetic Medicine team. The candidate will work collaboratively with cross-functional and thera More...

Responsibilities:As a Validation Engineer within the Mold & Capital Tooling Organization youll play a pivotal role on a global enterprise team collaborating with various sites around the this role youll facilitate or perform critical validation & qualification activities ensu More...

Responsibilities:Perform routine and advanced wet lab protocols in cellular and molecular biology.Maintain and culture human stem cells and their derivatives (maintenance passaging freezing/thawing).Support cell culture operations such as media preparation aliquoting reagents and gene More...

Responsibilities:Under limited supervision and in accordance with all applicable federal state and local laws/regulations procedures and guidelines the duties and responsibilities for this position are:Develop and implement qualification plans: Design comprehensive test protocols and More...

Job Description:Develop implement and maintain software quality assurance processes for non-product software used in medical device development.Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software.Support audits and in More...

Responsibilities:Effectively designs and codes SAS programs using BASE/SAS SAS/STAT SAS/GRAPH and SAS MACROS for assigned clinical projects(s).Produces and delivers CDISC and regulatory compliant SDTM and ADaM standard datasets.Creates and validates tables figures and listings (TFLs) More...

Job Description:The Facilities Suite & Elastomer Maintenance Mechanic Level III provides support to the Engineering Services group by operating and performing daily checks on Direct and Indirect Maintenance equipment/systems and assists higher level mechanics with repairs in compl More...

Job Description:Performs a variety of chemical analyses and GMP review in accordance with cGMP GLP DEA and company policies and procedures.Responsibilities:Perform routine testing (dissolution assay/degradant content uniformity and ID) of drug products in a cGMP laboratory.Complete al More...

Job Description:This position is a contract Packaging Engineering position within Clients Pharmaceutical segment R&D group. With some supervision performs sustaining engineering activities on current product packaging and packaging processes with priorities based on quality and co More...

Job Description:Quality Engineer w/ Design Quality Engineering experience product quality support design verification & Risk Management (ISO 14971) Failure Assessment (FMEA) MUST HAVE Medical Device experience.Quality Engineer will be a part of the clients Diabetes Post-Market Q More...

Responsibilities:Lead validation efforts for injection molding machines auxiliary equipment (e.g. dryers chillers robots) and integrated automation systems.Develop and execute validation protocols (SAT FAT IQ OQ PQ) for molding and downstream equipment.Support the qualification of new More...

Job Description:Were seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regula More...

Job Description:The Finishing Support Associate helps with assembling kits preparing packaging materials and supporting finishing area activities. This role follows safety and quality procedures in a clean manufacturing environment.Responsibilities:Assemble kits and screen product com More...

Job Description:Onsite Engineer plans leads reviews and front-ends Design Verification Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development.Responsibilities:Leads the Design Verifica More...

Job Description:We are seeking a Logistics Sampling Associate to support night shift operations within our Logistics department. The associate is responsible for sampling and handling incoming raw materials maintaining cleanroom standards and ensuring compliance with cGMP and SOPs. Th More...

Responsibilities:CSV Analytical and Enterprise Validation specialist IV will lead validation activities including but not limited to software updates new system introduction Administration of systems and applications and decommissioning activities as appropriate.This person will work More...