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Location:
Frederick, Maryland, United States
Job reference: R-049263
Posted date: Jul. 09, 2019
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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.

As a Validation Associate Scientist in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

***CTU (Controlled Temperature Units) Validation/Qualification experience is required for this position as it is one of the major responsibilities of this role***

Main Responsibilities

Scope:

  • Write validation protocols and reports
  • Perform validation activities described in validation protocols including thermal studies, cleaning, shipping, computer systems, equipment and utilities qualification and/or validation
  • Maintains an up-to-date knowledge of validation requirements, practices, and procedures
  • Works with validation and metrology contractors when required
  • Interacts with manufacturing sciences and facilities / engineering departments to facilitate protocol execution as necessary
  • Manage/maintain validation testing systems and equipment
  • Good technical writing skills
  • Able to read P&ID, Isometric and “As Built” drawings
  • Communicate effectively with supervisor and other departments workload, priorities, and issues to maintain validation schedule
  • In depth experience in several of these areas:
  • Sterility validation
  • FAT experience with large automated systems
  • Setting validation specifications for purchasing capital equipment
  • Project management experience with facilities upgrades and major construction projects
  • Experience performing IQ/OQ on large automated sys
  • Cleaning validation

Knowledge:

  • Complete understanding and wide application of technical principles, theories, and concepts in the field.  General knowledge of other related disciplines.

Problem Solving:

  • Provides technical solutions to a wide range of difficult problems.  Solutions are imaginative, thorough, practicable, and consistent with organizational objectives. 
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Freedom to Act:

  • Works under only general direction.  Independently determines and develops approach to solutions.  Work is reviewed upon completion for adequacy, in meeting objectives.

Impact:

  • Contributes to the completion of specific programs and projects.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

Interpersonal Communication:

  • Frequent inter-organizational and outside customer contacts.  Represents the organization in providing solutions to difficult technical issues associated with specific projects.

Education:

  • High School or Technical degree required.
  • Bachelors:  Engineering or Technical Field

Experience:

  • 4-7 years experience required.

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 law.

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Validation Associate Scientist (CTU Validation/Qualification) - Operations
QA

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