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A BDN client on the East Coast is looking for a senior mechanical engineer for mechanical subsystems, Design Partner relationships/customer engineering for the client's device. This position will have the consultant managing and directly working on the product development cycle of subsystems, including, but not limited to product engineering, product design, simulation, numerical modeling, manufacturing, and quality control.

A Black Diamond Networks client is looking for a QA consultant who can assist Phase I GMP manufacturing-related QA work, specifically defining instrument/equipment IOQ and calibration requirements, setting up Quality Systems for GMP production, reviewing/signing off on production batch records, and managing deviations/CAPAs related to GMP production.

A BDN client is looking for a project manager with at least four years of experience to come in and manage team meetings, communicate with stakeholders, help with agendas/timelines, respond to requests and action items, and help with portfolio reporting as needed. Candidates for this position should have experience working with Microsoft Project, Office Suite, and Visio. PMP experience would be a plus but, it is not required.

Our client is looking for a Software Engineer who can develop and support real-time software messaging applications and engineering duties for Wabtec, a leading supplier of technology based products and services for the rail and transit industries. This position has an opening for a dynamic, result-oriented Senior Software Engineer with a positive attitude to getting the job done.

Our client is looking for a CSV Consultant. They are implementing MasterControl Version 11 across all sites and need this consultant to implement and validate MasterControl Version 11. The execution will come after the implementation and validation of the new mastercontrol system. MASTERCONTROL VERSION 11 IS A MUST. The Manager said this person has to have implemented and validation MasterControl Version 11. All work can be done remotely after the first 2-3 days on-site.

Our client is looking to hire a CSV consultant to come on for at least six months of contract coverage. The client is implementing MasterControl Version 11 across all sites (Europe and the United States) and needs this consultant to implement and validate MasterControl Version 11.

The client needs a strong technical writer to support a BLA filing schedule for summer 2019. The technical writer will be participating in the regulatory team meetings and gathering the information from SMEs and regulatory strategy team to write various required documents and sections.

The client needs a strong regulatory affairs specialist to work on a BLA filing schedule for summer 2019. The majority of the work will center around the CMC sections of the BLA (module 2.3, module 3, etc.) and the candidate will be working on authority drug substance sections, coordinating review meetings for various sections, providing CMC support, and working with various SMEs to gather and compile necessary documentation/data and other related tasks.

A BDN client is looking for a consultant who will drive the initiative on updating an existing post-market surveillance system to meet EU/MDR compliance. The devices in questions are Class III devices and the consultant will be responsible for updating procedures, create new procedures and documents for PSUR.

A BDN client is looking for a design software development engineer to follow the AGM product development process, APQP, and Plex to ensure robust and timely product design and development activities. The primary responsibilities of the consultant will be to ensure the proper development of the DVP&R through the validation process. Candidates for this position should have experience working in the automotive industry working with embedded controllers.