Industry: Pharmaceutical / Biotechnology
Location: On-site in Ohio, USA
Employment Type: Project-Based / Contract
Position Summary
Inteldot is seeking an experienced Principal Engineer to work closely with team members to develop detailed engineering specifications, develop and support characterization testing, develop protocols and validation testing.
Key Responsibilities
- Work cross-functionally with individuals and project teams in Operations, Engineering and Automation.
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Create and execute to project plans and schedules.
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related process development documents for assigned projects.
- Provide deep technical assistance for junior engineers.
Skills & Requirements
- BS in Engineering with previous experience in a Pharma or medical device industry.
- 10 years current experience with engineering processes and procedures.
- Led projects from process development through PPQ approval process.
- Strong background in engineering for combination products.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Experience in drug/device combination product assembly and packaging.
- Familiar with the following standards: Quality System Regulation 21CFR820, Risk Management ISO 14971, EU Medical Device requirements.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
- Qualified candidates with strong Electrical Engineering, Mechanical Engineering, Systems/Software Engineering background