Hillsboro, OR (Onsite, LOCAL only)
Not available for C2C
Main Purpose of the Position:
The Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV).
Responsibilities:
Develop and manage the detailed project plans and timelines for the execution of validation activities.
Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities.
Lead the execution of CD/PQ/CV/PV/RV activities.
Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts.
Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.
Provide input into investigations with potential validation impact.
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.
Support the development of manufacturing documents as appropriate.
Qualifications/Requirements:
BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8 years with a BS (6 years with MS) experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required
Experience in the pharma/biotech industry is required.
Experience with cleaning and sterilization validation is required. Candidate must demonstrate understanding of cleaning and sterilization qualification requirements in cGMP environment.
Demonstrated project management skills.
Experience authoring, reviewing, and executing validation protocols.
Knowledge of cGMPs or equivalent regulations.
Working knowledge of formulation, filling, and, packaging, equipment qualification in a regulated environment is required.
Ability to work with internal teams, partners, suppliers and customers.
Operational excellence and industrial engineering skills are a plus.
Professional level written and oral communication skills.
