Associate Device Engineer (Syringes) – Direct Hire/Top $$

Our client, an RTP area biotech that is developing a portfolio of products to treat various diseases, is actively recruiting for a very bright and capable engineer to join its Science and Technology team.

This is an outstanding foot-in-the-door opportunity with one of the fastest-growing companies in the Triangle.  Company will pay excellent wage to attract and retain an excellent candidate.

Key Things to Note:

• The S&T team is developing syringes that are used to place drug-eluting implants into the patient.  This Engineer will be involved in equipment development/validation, device design, assembly optimization as well as clean room maintenance and manufacturing support.
• The role will support both aseptically manufactured and terminally sterilized products for both clinical and commercial use.
• This position will work closely with the Quality Assurance group as well as the Regulatory and Analytical teams to oversee the work conducted by third-party manufacturers. Experience with tech transfer and process optimization will be important.
• This Device Engineer will be responsible for ensuring that documentation is compliant with cGMP and company standards.  We seek an engineer with strong compliance and documentation discipline.
• This is an emerging company in a high stage of growth.  Seek adaptable, energetic and industrious candidate who will thrive in this dynamic and fast-paced setting.
• Travel is estimated at 10-20% - post-pandemic.

Selected Duties:

• Contribute to the development, tech transfer, and qualification of manufacturing processes for devices used in non-clinical and clinical development.
• Support the transition of device manufacturing processes from the development group through process optimization and scale-up. 
• Partner with the Quality Assurance group, R&D non-clinical group, clinical, regulatory, and analytical teams to support drug product manufacturing and testing activities conducted by CMOs and other vendors.
• Write and review CMC documents, including development protocols and reports, and maintain compliance with cGMP standards as appropriate for pre-clinical and clinical development.
• Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs)
• Develop SOPs, IQ/OQ/PQ Protocols and Reports, and other documents needed for development and manufacturing activities, including GMP equipment
• Maintain and schedule routine preventive maintenance activities on equipment and ISO 7/8 clean room facilities
• Maintain clean room logs/documentation, and maintaining clean room supplies
• Ensure production preparation by reviewing production schedules; studying and clarifying specifications; calculating requirements; assembling and weighing materials/supplies and assisting with supply chain logistics.
• Document production by completing forms, reports, logs, and records of equipment and batches

Targeted candidate will offer and Engineering degree and 1+ years of medical device development experience in a GMP compliant setting.  Familiarity with CFR Parts 210, and 211, ICH and FDA regulatory guidances will be important.  Other priorities include:

• Experience with equipment validation
• Experience with tech transfer
• Strong documentation skills, including compliance with GMP standards
• Experience in controlled clean room spaces (ISO 7 and ISO 8)
• Experience using materials characterization equipment (microscopy and metrology equipment is desirable)

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates only.