Validation Engineer

Réalta Technologies are currently searching for multiple Validation Engineers who will be supporting a large-scale capacity expansion project within our Medical Device client's manufacturing facility in Raynham, MA.

This position is based on-site as it will require the Engineer to interface with manufacturing equipment, medical device products, and cross-functional partners.

Responsibilities

Developing, writing, reviewing, maintaining and revising manufacturing

documentation, i.e. Process Work Instructions, Manufacturing Specifications,

Inspection Procedures to support product Manufacturing.

Supporting the development and execution of manufacturing equipment

qualifications (URS/FAT/SAT/IQ).

Supporting the development and execution of process validations (OQ/PQ/PV).

Developing, writing, and reviewing various validation deliverables, i.e. CSV-E,

Engineering Studies, etc.

Assessing, developing, writing, executing, and reviewing Test Method Validations (TMVs).

Developing, writing, reviewing, and updating relevant Process Risk Documentation (pRAS, pFMEA, FMCA).

Partnering with cross functional partners to ensure sound validation strategy and

smooth transitions to production go-live.

Ensuring adequate documentation where necessary within the Quality System.

Job Requirements

A minimum of a bachelor’s degree in engineering, Science, or related technical

field.

A minimum of 2-5+ years of related experience

Knowledge of statistical data analysis tools (e.g. Minitab).

Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T)

The ability to perform "hands on" troubleshooting and problem solving.

Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).

Strong communication and interpersonal skills.

Must have the ability to function in a team-based manufacturing environment.

The ability to collaborate with all levels of management in a cross-functional

team environment.

Experience in manufacturing: metal casting processes, CNC machining processes,

metal finishing processes, Gage R&R CNC equipment, plastic or wax injection,

laser processing or production automation preferred.

Experience in a Medical Device work environment preferred.

Good technical understanding of manufacturing equipment and processes preferred.

Experience working in both an FDA and European regulatory environment in manufacturing/operations preferred.