Randstad Validation Engineer Opportunity - MilliporeSigma in Rockville, Maryland
Validation Engineer Opportunity - MilliporeSigma
Saturday, October 15, 2016
Temp to Perm
Randstad USA Administration
The Validation Engineer prepares and executes various validation documents for equipment (CTU or Analytical) or computer systems at the BioReliance US site. They are expected to be able to independently prepare the required document templates and execute or oversee vendor execution of the documents. This individualy will also be responsible for the successful execution of validation activities meeting regulatory/company requirements per the prioritized timeline. The execution may require oversight of OEM contractor activities or other Validation resources.
ESSENTIAL JOB FUNCTIONS
- Contributes to the definition and planning of validation activities.
- Develop and write IQ/OQ/PQ protocols for appropriate equipment and systems within the guidelines of cGMP, internal policies and procedures
- Executes validation activities as defined in the project plan with moderate supervision.
- Completes validation deliverables in a timely fashion to allow for validation peer review and QA approval to be completed within the prioritized timeline.
- Initiates and completes change controls as needed for validation activities.
- Reviews and updates detailed system documentation, procedures, policies and standards in accordance with regulatory guidelines.
- Works with the Manager, Systems Validation to develop life cycle documentation and validation standards.
- May perform other related duties as required and/or assigned.
Working hours: First Shift - TBD
B.S. in Science or Engineering (e.g. Manufacturing, Industrial, Mechanical, Chemical)
--5 years validation experience.
--Prior experience in medical, biotechnology or similar field preferred
--Knowledge of manufacturing concepts and GMP. Analytical background highler preferred.
--Demonstrates potential for technical proficiency, scientific creativity, and collaboration with others and independent thought.
--Ability to grasp "new" analytical technology quickly.
--Must be a strong communicator
--Ability to prioritize multiple projects
--Presents results to program team (multi-disciplinary/cross-departmental). May assist peers in their validation efforts.
--Frequently interacts with functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others.
--Has broad understanding of regulatory requirements for computer systems and/or equipment typically in use in GxP environments
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