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Lieu: Olde West Chester, Ohio, États-Unis
ID de l'offre 11245873
Date de publication: 04/26/2019

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Description:

The Validation Engineer performs, leads and troubleshoots the C and Q process. Specializing in general validation support.

Essential Job Functions:

  • Author, Review and approve documentation needed for qualification of equipment and processes.
  • Prepare documentation of activities, actions, and/or results.
  • Monitor validation records to ensure compliance with regulatory requirements.
  • Ensure proper documentation practices during job activities.
  • Communicate validation policies and procedures to employees.
  • Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
  • Initiate appropriate action when process/protocol deviations occur.
  • Meet and Coordinate with representatives from other departments.
  • Review and approve change controls and document revisions.
  • Attend team meetings to discuss progress, initiatives, and/or other matters.
  • Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.
  • Facilitate the execution of validation protocols for processes, equipment, packaging, and/or cleaning.

Other Duties:

  • Participate in troubleshooting activities.
  • Close out deviations, CAPAs, and/or pAFCAs as needed.
  • Interact with regulatory agency personnel during audits and inspections.
  • Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
  • Participate in new equipment design specification.
  • Read technical publications and manuals, and write associated procedures.
  • Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
  • Occasionally Provide "off shift" support.
  • Assist process engineering and managers with improvement projects.
  • Recommend compliance resolutions to management.
  • Interact with other departments to implement corrective/preventative actions.
  • Read and interpret diagrams, drawings, and other schematics.
  • Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
  • Create new process modifications.

Minimum Requirements:

4-year degree in a technical discipline and 5 years of experience supporting quality or similar area in a regulated or cGMP environment.

Preferred Requirements:

4 Year Degree in Engineering.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by lawAstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Validation Engineer - Global Operations
Ingénierie

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