The Role
Principal Engineer responsible for developing engineering specifications, product requirements, system architectures, characterization plans, verification and validation protocols, and process development documentation for pharmaceutical and combination products. Leads projects through PPQ approval, supports testing and optimization, assesses technical risks, and collaborates with Operations, Engineering, and Automation teams. Provides technical guidance to junior engineers while managing multiple deadline-driven projects.
Summary Generated by Built In
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
Skills Required
- Bachelor’s degree in Engineering
- Previous engineering experience in the pharmaceutical or medical device industry
- At least 10 years of current experience with engineering processes and procedures
- Experience leading projects from process development through PPQ approval
- Strong engineering background in drug/device combination products
- Experience generating material and test specifications
- Experience writing protocols and reports
- Experience with process and test development
- Experience with prototyping and design verification
- Experience with DOE and SPC process optimization
- Experience with IQ, OQ, and PQ validation
- Experience with FMEA
- Experience with drug/device combination product assembly and packaging
- Familiarity with Quality System Regulation 21 CFR 820
- Familiarity with ISO 14971 risk management
- Familiarity with EU medical device requirements
- Strong problem-solving, risk assessment, and risk management skills
- Ability to manage multiple projects in a deadline-driven environment
- Strong Electrical, Mechanical, Systems, or Software Engineering background
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
