Job Description

Job Title: Quality Systems Validation Engineer
Location: Providence, RI
Experience Required: 4+ years
Employment Type: 12+ Month Contract

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.

• 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.

• 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.

• 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.

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