Validation Specialist

Bloomington  ‐ Onsite
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Keywords

Description

PHARMACEUTICAL VALIDATION SPECIALIST / VALIDATION ENGINEER

Bloomington, IN (Indiana)

PRIMARY FUNCTION:
  • To participate in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.


ESSENTIAL JOB DUTIES / RESPONSIBILITIES:
  • Manage multiple projects to provide documented validation of equipment, control systems, cGMP utilities and manufacturing processes
  • Develop validation master plans according to client processing steps
  • Review process flow diagrams and perform risk analysis
  • Schedule and sequence validation deliverables
  • Review of equipment submittals and design specifications
  • Analyze data associated with validation protocols
  • Develop and review functional requirements specifications as related to process equipment
  • Develop and/or review user requirement specifications
  • Develop and review facility impact and component criticality assessments
  • Develop validation protocols and associated summary reports
  • Review facility change logs and provide input on revalidation activities
  • Serve as an interface to process development and tech transfer teams
  • Conduct design qualification for relevant process equipment
  • Develop and review validation requirements and design deliverables
  • Ensure facility validation strategies and policies are followed
  • Lead validation projects as needed
  • Provide schedule integration for validation projects


MINIMUM WORK EXPERIENCE / EDUCATION REQUIREMENTS:
  • Bachelors Degree in Life Sciences, Chemical Engineering or Mechanical Engineering or equivalent experience
  • Sign company required confidentiality and non-compete agreement
  • Minimum 4 years of validation or pharmaceutical process engineering experience preferred
  • Excellent oral and written communication skills and computer literacy skills
  • Ability to effectively communicate with co-workers as well as management
  • Basic computer skills including Microsoft Office applications
  • Perform basic math skills and applications including addition, subtraction, multiplication and division including the ability to understand decimals
  • Ability to coordinate efforts of various departments and contractors


To find out more about Real please visit www.realstaffing.com
Start date
08/2013
From
Real Staffing
Published at
17.08.2013
Project ID:
584828
Contract type
Permanent
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