Manufacturing validation engineer

Pentangle Tech Services | P5 Group; North Haven (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

Pentangle Tech Services | P5 Group is seeking a capable Manufacturing/Process Validation Engineer to lead IQ/OQ/PQ activities, develop test methods for V&V, and validate methods for medical-device production. The role requires strong cGMP knowledge and clean-room experience in a fast-paced environment.

Candidates should have a BS in Engineering with 5 years of relevant medical device manufacturing experience, plus proficiency in Excel and Minitab.

Qualifications

• Bachelor of Science in Engineering or combination of relevant education and experience.
• 5 years relevant experience in medical device manufacturing.
• Expertise in medical device manufacturing with strong working knowledge of cGMPs.
• Clean room environment experience.
• Experience with Test Method Validation and/or Measurement System Analysis is preferred.
• Knowledge of Excel and statistical packages (Minitab preferred).
• Familiarity with FDA Quality System Regulation (21 CFR 820) and ISO 13485.

Responsibilities

• Process and equipment qualification (IQ/OQ/PQ).
• Development of test methods for Design V&V, Process Validation, and Production.
• Validation of test methods.
• Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work.
• Authoring/releasing of new test methods and editing/redlining of old test methods.

Skills

Detail oriented

Strong organizational skills

Cross-functional collaboration

Deadline-driven

Education

Bachelor of Science in Engineering

Tools

Excel

Minitab

Microsoft Word

Microsoft PowerPoint

Microsoft Project

Job description

• Process and equipment qualification (IQ/OQ/PQ).
• Development of test methods for Design V&V, Process Validation, and Production
• Validation of test methods
• Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
• Authoring/releasing of new test methods and editing/redlining of old test methods

Job Duties

• Process and equipment qualification (IQ/OQ/PQ).
• Development of test methods for Design V&V, Process Validation, and Production
• Validation of test methods
• Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
• Authoring/releasing of new test methods and editing/redlining of old test methods

Education/experience

• This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.
• Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
• Clean room environment experience
• Manufacturing Engineering and automation experience.
• Experience with Test Method Validation and/or Measurement System Analysis is preferred.
• Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
• Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
• Strong organizational skills, detail oriented.
• Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
• Ability to work to a deadline and to handle multiple tasks simultaneously.
• Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.