Validation Engineer

ND Global Consulting Services, Inc; Ohio; On-site; USD 120,000 - 180,000; Full time

Job summary

ND Global Consulting Services, Inc. seeks a senior engineering professional to spearhead cross-functional product development within pharma/medical devices. You will drive architecture, design and verification activities, lead project plans, and guide junior engineers through PPQ processes.

The role requires a BS in Engineering with 10+ years in engineering processes, a strong background in combination products, and familiarity with 21 CFR 820, ISO 14971, and EU medical device regulations.

Qualifications

• BS in Engineering; pharma or medical device industry experience.
• 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 Quality System Regulation 21CFR820, 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.

Responsibilities

• Work cross-functionally with Operations, Engineering and Automation teams.
• Create and assess product requirements for technical coverage and integration of subsystems.
• Create and execute project plans and schedules.
• Develop, execute, and review architecture and design documents and verification plans.
• Provide deep technical assistance for junior engineers.

Skills

Engineering Leadership

Pharma/Medical Device

Systems/Software Engineering

DOE/SPC

Education

BS in Engineering

Job description

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:

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.