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.
- 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.