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Validation Engineer
QC/IQ/OQ/PQ/Pharmaceutical
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Location: Lynnwood, WA
Pay Rate: Contract: 33.55 to 44.91 $/hr
Salary: 69.78 to 93.41 K$/yr
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Position Type/ Job Duration: Contract 6 - 12 months
Education Required: BS 
Years Experience Required: 2

Industry:
Mfg
Job Posted: 12/18/2017
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Apply Deadline: 12/18/2017
Job #: 132395RP1
Job order status: Client is actively seeking candidates
Relocation available: Not Available


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A French multinational pharmaceutical company is currently seeking a Validation Specialist in Lynnwood, WA. This is a 11-month CONTRACT position, with the possibility of extension. No per diem available.

Responsibilities

  • Performs validation and re-qualification field studies on equipment and systems, under direct supervision until fully trained and subsequently independently. Participates in failure investigations associated with studies being executed. Conducts non critical failure investigations independently (with minimal supervision).
  • Authors IQ/OQ/PQ protocols in conjunction with manager/other (and subsequently independently) validation group members. Assists in the assembly of IQ/OQ/PQ final report packages in conjunction with manager/other (and subsequently independently) validation group members.
  • Tracks validation samples, QC results and authors final reports for validation studies executed. Coordinates equipment preparation prior to beginning validation/qualification testing. Maintains and operates validation equipment, as directed. Assists in maintenance of validation archives under supervision until fully trained.
  • Confirms SOPs are in place and systems are operational prior to beginning validation studies. Drafts and revises SOPs under direct supervision until full understanding has been demonstrated. Communicates project requirements to manager for acceptance and regularly informs them of current project status.
  • Communicates technical issues to validation engineer II//III and/or manager for resolution. Coordinates, with validation engineer II//III and/or manager assistance, scheduling and execution of specific validation projects with system owners and all involved departments

Requirements

  • Bachelor’s degree and 2+ years' experience required. Masters degree and experience in pharmaceutical/biological processing, cGMPs, validation /qualification (i.e., cleaning/equipment/process/computer) are preferred. Experience with Microsoft Office products, including Word and Excel is required

Benefits

  • Health Benefits
  • 401K
 
 
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Related Keywords quality control, quality control lab, laboratory, validation, technical writer, documentation, technical report, technical report documentation, protocol documentation, cgmp, laboratory equipment qualification, technical, validation studies
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