Position Summary

The Validation Engineeris responsible for the Validation Department within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for finished pharmaceuticals.

Job Responsibilities

• Work with the validations team to ensure timely completions validation's task
• Write and execute Validation Protocols
• Ensure projects are implemented and completed within the scope and agreed time lines
• Schedule validation activities
• Clean validation samples
• Execute with the engineering team equipment IQ/OQ/PQ
• Review and approve validation protocols, summaries, SOPs, Work Instructions and ensuring they conform with operating procedures and all current regulatory standards
• Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to ensure correct interpretation of the information
• Review all data presented in Final Summary Reports and ensuring data accuracy and it meets acceptance criteria
• Ability to be the SME (Subject Matter Expert) in equipment qualification
• Approve change controls
• Review and approve work order risk assessments
• Work on validating rooms, equipment
• Perform re-qualifications
• Perform Cleaning Validation
• Perform Computer Validation
• Perform qualifications and re-qualifications of sterilizer
• Ability to work in pharmaceutical induct in (QA, OPS, or Validation) departments
• Maintain the quality and integrity of information required for validation records
• Ensure that projects are implemented in accordance within the agreed scope and time lines
• Perform other duties as assigned
  
  

Required Skills

• Must be able to read and write English, verbally communicate with co-workers and management, and perform mathematical calculations
• Must be able to follow instructions, attention to details, multi-task, and handle multiple priorities without undue stress or errors
• Must be able to sit, stand, and read for extended periods of time
• Must be able to lift and carry 25 lbs,
• Must be able to walk while carrying items
• Must be able to see very small print and tiny graduations
• Must have strong problem solving skills
• Ability to work in manufacturing setting
  
  

Education And Experience Requirements

• Bachelor's degree in Engineering and previous experience in Validation required
• Must be proficient with MS Word and Excel
• Must have previous experience in pharmaceutical industry in (QA, OPS, or Validation) departments preferred
  
  

EOE, including disability/vets.