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Superior Group is looking for Engineer 3 for our Client located in Newark, DE
Work as part of a team with Client staff to transition the design of biochemical reagents, calibrator and control products and other fluidic chemical compounds from development laboratory-based processes into full-scale manufacturing processes.
This activity requires an experienced individual that can operate at from a system level perspective and can write process validation reports including the authoring and execution of IQ, OQ and PQ protocols for specific equipment, test and process steps as well as the generation of an entire process map and the execution of the a system level process validation for a variety of biochemical reagents used in clinical diagnostics applications.
The successful applicant will be expected, as part of the validation activities, to design and oversee a full statistically designed parametric characterization study of process steps to be validated.
Ideally, the candidate would also have experience in design transfer activities specifically including the risk analysis of a design from safety, quality, regulatory cost and sustainable supply chain & manufacturability perspectives and the ability to drive cross-functional PFMEA reviews and participate in process hazard reviews
Evaluation of process equipment to produce custom formulated liquid reagents as well as automated material handling equipment to label and package final product
Physical/chemical characterization of product, metrology, performance testing and working with team to correlate impact of process parameters on end-use product.
Documentation of processes, validations and authoring technical protocols, reports and testing procedures in a regulatory-compliant environment.
Development of quality –relevant documents and procedures
Lead and conduct troubleshooting activities as necessary to determine the root cause for failures and identify and verify corrective actions.
Must be familiar with design change, design verification and validation requirements for products and processes.
Should be able to plan and execute assay verification and validation studies.
Should be knowledgeable about FDA and other external regulatory agency requirement including cGMP, familiar with safety aspects of bio hazardous materials; provide technical support for regulatory submissions/registrations.
Additional relevant technical experiences may include: biochemical/chemical manufacturing experience, fluid process design (precision dispensing/filling equipment, mixing, filtering, etc.,)
Relevant work experiences may include: Quality Affairs, Chemical/Biochemical process development, in-vitro diagnostic or pharmaceutical product manufacture, manufacturing, compounding and processing of pharmaceuticals, working knowledge of clinical chemistry and application of automated assays in clinical chemistry laboratories.
Ability to build strong working relationships in cross-functional project teams to develop technical solutions to problems
Manufacturing of clinical biologic reagents for FDA regulated diagnostics industry, utilizing & authoring procedures, managing bills of materials and meeting quality system requirements.
Manufacture, support, and troubleshooting of new products.
Validation of products/processes into an operations environment.
The individual will be expected to understand and comply with the Quality System Regulation in order to meet all FDA, ISO and IVDD standards.
The position may be expected to develop, plan, execute, and functionally direct project(s) with complex features.
Position will oversee all aspects of project work to ensure completion within expected parameters and time frame.
Results will be communicated to peers and management via standard written, oral, or visual means.
Good skills are expected in: computers, customary MS Office programs, various types of communication tools.
Position will be involved in preparation and