cGxPServe

Responsibilities: Provide operational support for MES systems addressing issues changes and enhancements. Configure MES applications based on manufacturing workflows and process requirements. Translate business and manufacturing needs into system functionality and technical specifica المزيد...

Responsibilities: Work with Clinical Data Management (CDM) Lead to support operational activities for one or more programs. Monitoring data management vendor quality of work through key performance metrics. Maintain program level DM deliverable timelines in accordance with program de المزيد...

Job Description: The Principal Scientist Manufacturing Science and Technology (MSAT) Materials Science will support the Our client Cell and Gene Therapy (VCGT) manufacturing network by applying a deep understanding of relationships between materials properties process conditions a المزيد...

Responsibilities: Create specifications for the structure of ADaM data sets for individual studies. Develop SAS programs for creation & validation of ADaM data sets following CDISC standards & of Tables Listings & Figures. Ensure accuracy of SAS programs by reviewing code log & outpu المزيد...

Job Description: We are seeking a Manufacturing Process Engineer to join the Manufacturing Science and Technology (MS&T) team supporting latestage manufacturing and PPQ readiness for an autologous cell therapy product. This role requires a strong background in GMP operations process c المزيد...

Job Description: The GMP Asset Mechanic is responsible to ensure that GMP production assets are evaluated prior to purchase qualified and documented as needed maintained and commissioned prior to use and properly decommissioned and stored for future use. These individual reviews: equi المزيد...

Job Description: Responsible for the dispensing of raw materials liquids and powders (hazardous and nonhazardous) acids/bases under cGMP conditions to support the manufacture of therapeutic proteins (API) Individual will be required to perform and monitor all dispensing processes and المزيد...

Responsibilities: Lead technical planning and execution of NPI projects from concept through commercialization. Collaborate with R&D Quality Regulatory Manufacturing and Supply Chain teams to ensure smooth product transition. Own the technical documentation including design history f المزيد...

Responsibilities: This individual will play a critical role in supporting the start up of 4 manufacturing lines ensuring successful equipment transfers and validation processes. This individual will provide engineering leadership manage validation activities and develop action plans المزيد...

Roles and Responsibilities: Mandatory Skills Computer System Validation GxP Regulations Validating GxP systems 10 years experience in Computer System Validation ERP/WMS R&D systems A senior consultant with expert knowledge of GxP and Computer System Validation. Expertise in authorin المزيد...

Job Description: Join a globally recognized leader in medical technology that specializes in lifesaving devices used in blood donation and plasma separation. This Validation & Quality Engineer 3 role supports a highimpact stable business unit working on a brandnew product thats enter المزيد...

Job Description: The Category Buyer is responsible for Capex Process Equipment procurement activities for Lonza USA sites of approximately $10m to $500m. The Category Buyer is responsible for all assigned procurement activities related to process equipment for projects across North Am المزيد...

Job Description: The Category Buyer is responsible for Capex Process Equipment procurement activities for Lonza USA sites of approximately $10m to $500m. The Category Buyer is responsible for all assigned procurement activities related to process equipment for projects across North Am المزيد...

Job Description: The overall position is to support regulatory and agency inspections audits investigation and inquiries regarding product design and manufacturing quality. Review the adequacy and correctness of changes to Bill of Materials Assembly procedures Drawings Component spec المزيد...

Job Description: The GMP Asset Mechanic is responsible to ensure that GMP production assets are evaluated prior to purchase qualified and documented as needed maintained and commissioned prior to use and properly decommissioned and stored for future use. These individual reviews: equi المزيد...

Responsibilities: Required to be licensed in Illinois and preferred BLS/ACLS otherwise will provide. An experienced licensed Professional with relevant therapeutic specialty in an academic or hospital environment. Excellent verbal and written communication skills/Documentation. Stays المزيد...

Responsibilities: Required to be licensed in Illinois and preferred BLS/ACLS otherwise will provide. An experienced licensed Professional with relevant therapeutic specialty in an academic or hospital environment. Excellent verbal and written communication skills/Documentation. Stays المزيد...

Responsibilities: Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a crossfunctional team for new product development of medical devices. Develop and implement methods and procedures for inspecting testing and evaluating the المزيد...

Roles & Responsibilities: Project Management Professional (PMP) required. 5 years of project management experience. 3 years of RECENT pharmaceutical industry experience. Experience in working in Aseptic Areas (cleanrooms) required. Science/Engineering degree or 10 years of related ex المزيد...

Roles & Responsibilities: PMP or 3 years of related project management experience. 2 years of RECENT pharmaceutical industry experience. Experience in working in Aseptic Areas (cleanrooms) required. Science/Engineering degree or 10 years of related experience. Experience in Microsoft المزيد...