5796 Validation Engineer I

Responsibilities:
Support the development, execution, and management of the timelines for the execution of CD/PQ/CV/PV/RV activities.
With the support of the validation manager, learn to prepare validation & change control, documentation, including protocols, summary reports, etc., for validation activities.
Track and trend activities and report out on issues such as impact to predetermined timelines and problems as needed.
Provide input into investigations with potential validation impact.
Support the preparation for the validation program during periodic audits and regulatory inspections.
Coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.
Support the change management system for validated equipment, utilities, and facilities.
Assist with preparation and review of relevant sections of regulatory submissions.
Serve as a representative on cross-functional and multi-site teams.
Support development of formulation, filling, and packaging, area SOP’s and manufacturing documents as appropriate.
Foster an environment that encourages continuous learning.
Maintain expertise as necessary to stay abreast of technical and industry advancements.

Qualifications / Requirements:
BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 0-2 years experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required.
Experience in the pharma/biotech industry is a plus. Knowledge of cGMPs or equivalent regulations.
Working knowledge of formulation, filling, and packaging, equipment qualification in a regulated environment.
Demonstrated understanding of project management skills.
Ability to work with internal teams, partners, suppliers, and customers.
Operational excellence and industrial engineering skills are a plus.
Professional level is written and oral communication skills.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.