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Sr Validation Engineer

Cornelius, OR 97124

Posted: 09/11/2023 Employment Type: Contract Job Category: Engineering Job Number: 584516 Is job remote?: No Country: United States

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. 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cornelius, OR

Unlock your career potential in beautiful Cornelius, Oregon! Nestled in the heart of the Pacific Northwest, Cornelius offers a blend of vibrant city life and serene countryside, making it an ideal place to grow both personally and professionally. With scenic vineyards, charming wineries, and proximity to the stunning Tualatin Valley, Cornelius provides a unique backdrop for your career journey. Explore job opportunities near iconic landmarks like the Helvetia Tavern, Oregon Air Show, and Adelante Mujeres Mural, or immerse yourself in the local culture at the Venetian Theatre. Indulge in delicious farm-to-table cuisine, explore local art galleries, or enjoy outdoor activities at places like Rood Bridge Park. Join our team today and discover the endless possibilities that Cornelius has to offer!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.