Principal Engineer

Inteldot; New Albany (OH); On-site; USD 120,000 - 180,000; Part time

Job summary

Inteldot is seeking a Principal Engineer to craft detailed engineering specs and support characterization testing for pharmaceutical projects in Ohio. The role requires developing protocols and validation plans, and coordinating with Operations, Engineering and Automation teams.

You will review design documents, perform risk assessments, mentor junior engineers, and ensure compliance with 21 CFR 820, ISO 14971, and EU medical device requirements.

Qualifications

• BS in Engineering; pharma/medical device sector preferred.
• 10 years of relevant experience in engineering processes.
• Led projects from development through PPQ.
• Strong background in engineering for combination products.

Responsibilities

• Develop engineering specifications and validation plans.
• Support characterization testing and protocol development.
• Coordinate cross-functional teams across operations, engineering and automation.
• Prepare and review design documents, DOE, IQ/OQ/PQ.
• Provide technical mentorship to junior engineers.

Skills

Engineering leadership

Cross-functional collaboration

DOE / SPC

Risk assessment

FMEA

Documentation writing

Regulatory knowledge

Multiphase project management

Education

BS in Engineering

Job description

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