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A BDN client is looking for a Software Engineer who has a Risk-Based Approach in GSPR/EUMDR. This consultant should understand the framework and walk through the process tactically for SDLC; not from a procedural QA perspective but from a software side. He/she will be assessing sequence flows and building the traceability matrix to evaluate what design risk impacts are and then validate to IEC-82304/62034.

A BDN client is looking for an Equipment Validation Engineer who understands Metrology equipment and has a machinery type background. He/she needs to write and execute IQ, OQ protocols and be familiar with 3 axis machining. The client is looking for a Mid-level engineer to truly execute vs manage or oversee. The consultant must be willing to drive their section of work to completion but work cross-functionally as this is a plant-wide effort. The consultant must have good technical writing skills and Metrology equipment experience for this role.

A BDN client is currently in the process of transferring 10 brand new solution products and 2 that are already produced there from another site. The client needs a team of Validation Engineers to perform technology transfers, mix time, hold time, cleaning and process validations to ensure the final formulation, bill of materials, manufacturing processes, packaging, labeling, acceptance specifications and methods result in solution products that are acceptable, repeatable, verifiable and executable by the receiving site.

A BDN client is currently in the process of transferring 17 solution products from another site, and only 1 that is not currently produced at their facility. The client needs a Validation Engineer to help revise existing MVP to be updated with new strategy, perform technology transfers, mix time, hold time, cleaning and process validations to ensure the final formulation, bill of materials, manufacturing processes, packaging, labeling, acceptance specifications, and methods result in solution products that are acceptable, repeatable, verifiable and executable by the receiving site.

A BDN client is looking for a Project Manager to drive a collaboration project with one of their suppliers of a key component for the client’s product. The product is going into obsoletion and they are working on the next generation of the component which will require work at both the supplier and the client. The product is a MR Imaging type device so a consultant with medical device and design control knowledge is required. Additionally, a consultant familiar with diagnostic imaging systems or software would be a strong plus (if not would look at candidates with capital hardware experience).

A BDN client is looking for a QMS/Document Controls Consultant and needs someone who has worked with Greenlight in the past and understands how it runs. The client has an extended amount of outdated documents that need to be uploaded into this software and linked properly. The company is still in development, they are not certified by the FDA, but anyone with knowledge of ISO 13485 would be a huge plus. A Bachelor's Degree in a related field is preferable for this role.

A BDN client is looking for a Medical/Technical Writer who has a background with genetic sequencing. This role is not working on submissions but will be working on writing for clinical utility protocols and validation studies. They need a consultant who has a strong scientific background with genetic sequencing. An IVD background is a plus, scientific experience is more important. He/she will be working on synthesizing validation data from the IVD team into presentable summaries. Some data integrity, editing, and review are needed. Protocol reports and documentation reviews, including statistical reports, are essential.

A BDN client is looking for a Data Integrity Remediation Consultant. There are currently 9 CAPA's that are specific to Data Integrity Gaps with analytical instruments within the Quality Control and Production operations groups. The consultant will be responsible for drafting and executing plans, risk assessments, procedures, protocols, and reports associated with Data Integrity (DI).

A BDN client is looking for a senior-level Controls Engineer with Siemens PLC and Allen Bradley experience. The client has a 50/50 mix of control systems in the site and mostly AB for Packaging equipment. They are looking for someone with a full understanding of Control Systems, Integration, Programming, Coding, Servo Background, etc. The client is installing new lines, new products, equipment, and wants to have someone with a broad controls knowledge to focus on a variety of controls engineering activity.

A BDN client is looking for a QA Engineer consultant to come on-site and help perform a variety of Quality Assurance and international regulatory activities that ensure compliance with FDA, EU, and ISO regulatory requirements. This consultant will be supporting day to day activities; there is not a backlog of work. He/she will oversee and manage the complaint process, facilitate the non-conforming material along with the Document Control process.