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Job Description: POSITION SUMMARY
• Validation engineer with experience in equipment, HVAC, utility and process qualification within a pharmaceutical industry. Previous plant experience is recommended. Background in aseptic processing, microbiology, environmental monitoring, chemistry, and production is recommended. The additional resources are requested for a total of fourteen (14) weeks starting in December 2017 and ending March 2018 to support Winter Shutdown changes. Hours can involve weekend or night shifts. Validation activities including writing system impact assessments, oversight of engineering during shutdown activities, execution of installation qualification, operational qualification, performance qualification, and summarizing qualification results/drafting qualification report summaries. The support staff must act in accordance with plant safety requirements, training and procedures.
• Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Executes equipment, facility, utility and computer system, Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
• Oversee and assist Engineers and/or Technicians with their assigned projects.
• Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.
• Thorough understanding of risk based validation, industry standards and best practices for validation.
• Will interact with Shutdown stakeholders: Engineering, Operations, Quality, Safety, Planning, Contractors, etc.
• Weekly/daily meeting attendance as required.
• Will participate in team led by Pharmaceutical group leaders.
EDUCATION AND EXPERIENCE
• Education: BS/BA degree in science, engineering, manufacturing technology or closely related field or combination of education and work experience
• Experience: Recommended minimum of 4 years pharmaceutical validation experience
TECHNICAL SKILLS REQUIREMENTS
• Knowledge of ICH and other regulatory guidelines; demonstrated ability to interpret and apply these guidelines to document writing
PHYSICAL POSITION REQUIREMENTS
• Logistics: Requires contractor to be on-site weekly with travel home every other weekend
• Must be able and willing to work beyond office hours which may include weekends.
• Requires routine sitting, standing, walking, listening and talking
• Acute mental and visual attention at all times
• Handle multiple projects while managing frequent interruptions
• Requires moderate lifting or moving up to 25 pounds (lbs)
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