Validation Engineer

GSK•King of Prussia, PA

2d•Onsite

About The Position

This Validation Engineer will be responsible for equipment/facility validation projects in a hands-on role including writing validation protocols, scheduling and executing testing, gathering and analyzing data, and writing validation summary reports. This person will participate as a supporting member representing validation on project teams. Validation Engineers will lead specific validation projects. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Design required validation studies and write protocols for the facility and equipment. Coordinate resources required to complete validation studies in a timely manner. Execute validation studies per required schedules in a safe, compliant manner (e.g. LOTO). Analyze test data and report questions/issues. Lead and document investigations of failed validation test results. Complete validation protocols and validation summary reports with necessary approvals. Support the review of new systems and modifications to existing systems to ensure designs comply with cGMPs and are able to be validated and maintained in a validated state. Maintain validation equipment and supplies to enable validation to be completed per schedule requirements. Support the development of required validation procedures and practices with respect to the facility. Identify issues and/or improvements to validation procedures, practices, and policies related to validation, equipment and processes.

Requirements

Bachelor's degree in a scientific discipline OR 2+ years of experience working in a regulated GMP environment with an Associated degree

Nice To Haves

1+ years of experience in Validation, Automation or Process engineering
Familiar with cGMPs.
Strong interpersonal and organizational skills.
Technical understanding of the industry and validation practices related to the pharmaceutical industry is preferred.
Strong verbal and written communication skills.
Must be able to interact well with peers and senior personnel in multidisciplinary teams involving scientific, engineering, and operational disciplines.
Able to take directions and effective at implementing decisions.
Must have strong technical writing skills

Responsibilities

Design required validation studies and write protocols for the facility and equipment.
Coordinate resources required to complete validation studies in a timely manner.
Execute validation studies per required schedules in a safe, compliant manner (e.g. LOTO).
Analyze test data and report questions/issues.
Lead and document investigations of failed validation test results.
Complete validation protocols and validation summary reports with necessary approvals.
Support the review of new systems and modifications to existing systems to ensure designs comply with cGMPs and are able to be validated and maintained in a validated state.
Maintain validation equipment and supplies to enable validation to be completed per schedule requirements.
Support the development of required validation procedures and practices with respect to the facility.
Identify issues and/or improvements to validation procedures, practices, and policies related to validation, equipment and processes.