Process Validation Engineer

GxP Systems, and Irish company, currently have a number of open roles for contract Process Validation Engineers based in Ohio.

The Process Validation Engineer will be responsible for the generation and execution of Process Validation documentation relevant to automatic and manual processes at our client site. The Process Validation Engineer will be experienced with process and equipment validation in an FDA regulated environment.



Responsibilities



The main responsibilities of this position include, but are not limited to:

Develop Process Qualification Protocols (IQ/OQ/ PQ).

Develop Equipment Qualification Protocols (IQ/OQ/ PQ).

Qualify Process Verification techniques (Gauge R and R, etc.).

Execute and report on validation protocols.

Resolve deviations in a timely manner.

Generate and resolve Change Controls.

Provide advice on Lean Validation and Science/ Risk based approach to validation sampling.



Requirements

Third level qualification in Engineering, Science, and/or related discipline.

Strong statistical understanding is an advantage.

Qualification experience in a project environment within the medical device industry.

Ability to apply cGMP regulations and guidelines to all aspects of work.

Excellent interpersonal skills.

Ability to operate as part of a team is critical.

Ability to work alone, as required.

Excellent communication skills, both written and verbal.

Attention to detail.

CVs to recruitment[at]gxpsystems.com