Sr Validation Engineer
4625 NE Brookwood Pkwy Cornelius, OR 97124 US
Job Description
Description:
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.
Pay Rate Range: $85-105/hr. Salary will be commensurate with experience.
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