Quality Systems Validation Engineer

Job Title : Quality Systems Validation Engineer

Location : Providence, RI

Experience Required : 4+ years

Employment Type : 12+ Month Contract

Job Summary

We're looking for a Quality Systems Validation Engineerr to support equipment and process validation activities within a regulated manufacturing environment. This role is ideal for someone who understands validation principles, quality system requirements, and documentation practices within FDA-regulated industries, particularly medical devices or combination products. You'll be responsible for developing and executing validation protocols, maintaining compliance with internal and external quality standards, and collaborating with cross-functional teams to ensure the reliability and consistency of production systems and equipment.

Key Responsibilities

Develop and implement Quality System documentation aligned with regulatory and company validation standards.

Prepare, execute, and review validation documents including URS, IQ, OQ, and PQ protocols.

Design and apply appropriate validation methodologies, incorporating statistical analysis where needed.

Perform and coordinate qualification and validation activities for equipment, utilities, and processes.

Analyze data, compile results, and generate comprehensive validation reports.

Contribute to user and functional requirement specifications for new or modified equipment and systems.

Collaborate with Contract Manufacturers to ensure design and functional requirements are properly met.

Provide technical support to R&D, manufacturing, and quality teams to ensure smooth technology transfer.

Ensure adherence to GDP (Good Documentation Practices), cGMP, and all internal Quality System requirements.

Manage multiple validation projects, track timelines, and proactively communicate risks or delays to stakeholders.

Required Qualifications

Bachelor's or Master's degree in Engineering or a related technical field.

Minimum of 4 years of experience in a regulated medical device, pharmaceutical, or biotech environment.

Strong background in equipment and process validation, including IQ / OQ / PQ and PV activities.

Experience with Design Documentation (URS, FRS, DS) and Quality System processes such as Change Control and Non-Conformance Management.

Familiarity with Computer System Validation (CSV) lifecycle and related documentation.

Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

Excellent written and verbal communication skills with a strong emphasis on technical writing.

Ability to work independently, handle multiple projects, and coordinate with cross-functional teams effectively.

Preferred Qualifications

Experience with device-biologic combination products.

Hands-on experience in Process Engineering or Process Validation.

Solid understanding of statistical tools used in validation and process control.