Validation Engineering Associate

MAJOR RESPONSIBILITIES:

• Conduct validation, temperature mapping, and calibration activities
• Measure instruments, software performance and machine performance to determine operating as defined and required
• Establish and maintain methods to control the biomanufacturing processes and develop effective ways to monitor product performance, and analyze data
• Generate, execute and review qualification and validation studies according to approved protocols and SOPs (Standard Operating Procedures)
• Write protocol documents and reports to show how each biomanufacturing system, piece of equipment, method, software or process is validated
• Analyze the results of testing and determine their acceptability against predetermined criteria
• Adhere to strict documentation, reviews and approvals. Investigate and troubleshoot problems and determine solutions or recommendations for changes and improvements, including expanding facilities and upgrading equipment and software

• Provide validation related support to other departments and leaders
• Other duties as assigned

• Bachelor's degree in science or engineering
• Knowledge of and experience with GMPs (Good Manufacturing Process).
• Knowledge of and experience with Validation programs, Installation qualification (IQ), Operational Qualification (OQ) Performance qualification (PQ)
• Knowledge of and experience with DOE (Design of Experiment)
• Knowledge of and experience with various statistical analysis and statistical tools
• Documented experience with technical report preparations in English
• Experience with problem solving skills, Gage R and R, cPK analysis, OEE, control charts. FMEA, Risk Analysis, CAPA
• Working knowledge of ISO , 21 CFR and various regulating agencies:
  Health Canada, FDA and EU
• Proficient command of the English language, both written and verbal

Demonstrated ability to apply the following behavioral competencies on the job:

• Teamwork:
  Ability to work independently and effectively and productively with others
• Communication:
  Understand and follow verbal and written instructions
• Problem Solving:
  Anticipating, analyzing, diagnosing and resolving problems
• Organization and Planning:
  Utilizing logical, systemic and orderly procedures to meet objectives
• Flexibility:
  Ability in adapting to change