Senior Validation Engineer
Compli

Job Info

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Senior Validation Engineer (Life Sciences)

GBA is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior Validation Engineer to join our growing team. GBA differentiates itself through an integrated approach to engineering, construction commissioning and validation.

Responsibilities:

• Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects
  

• Prepare and execute commissioning / validation lifecycle documents
  
• Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
  
• Write summary reports for validation and qualification protocols
  

• Support project milestones, priorities and deadlines
  

• Write operating procedures for technical equipment and practices and procedures
  

• Perform system and process risk assessments and analyses
  

• Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management
  

• Develop project specific validation plans and strategy
  

• Able to manage and execute multiple projects to meet client•s priorities
  

• Provide a practical approach to problem solving
  

Requirements:

• Bachelor•s degree in a related life sciences or engineering field
  

• 8 • 10+ years GMP experience
  
• Ability to converse about scientific matters
  
• Candidate must have sterile/aseptic facility CQV experience.
  
• Thermal mapping experience is essential.
  
• Sterilization/SIP experience a plus.
  
• Ability to work independently or in collaboration with others
  

• In depth understanding and application of validation principles, concepts, practices and standards
  

• Considered a Subject Matter Expert (SME) in one area of validation
  

• Proficient in current Good Manufacturing Practices and other applicable regulations
  
• Experience with Sterile/Aseptic Filling.
  

• Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report
  

• Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards
  

• Excellent written communication skills with emphasis in technical writing
  

• Proficient in Microsoft Word, Excel, Power Point and Project
  

• Must be willing to travel regionally and / or nationally throughout the U.S
  
• Candidate must be on site during the core hours M-F from 7am-3pm
  

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