Validation Engineer I

Position Summary: 

The Validation Engineer is 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.