Senior Validation Engineer

1 month ago


Germantown, Maryland, United States Verista Full time
Job Overview

Verista is seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our commissioning and qualification team, you will be responsible for ensuring the highest level of quality and compliance in our clients' facilities.

Key Responsibilities
  • Lead the commissioning and qualification process for multiple projects simultaneously
  • Develop and execute validation plans, protocols, and reports
  • Collaborate with cross-functional teams to ensure seamless project execution
  • Conduct risk assessments and impact analyses to identify potential issues
  • Design and execute engineering studies to verify critical process parameters
  • Verify system drawings, including P&IDs and I&C drawings, and electrical schematics
  • Conduct and document impact and risk assessments, including direct, indirect, and no-impact systems and functions
  • Work with equipment OEMs and installation vendors to ensure compliance
  • Maintain detailed records of qualification and validation activities
  • Author and execute technical commissioning, qualification, and validation documentation
  • Run test scripts and document results
  • Adhere to project schedules and maintain clear records
Requirements
  • 5-7 years of experience in commissioning and validation activities in GMP-regulated environments
  • Demonstrated experience in authoring and executing FAT, SAT, IOQ, and CSV protocols
  • Experience with 6 reactors (2,000 gal+), receivers, filter dryers, centrifuges, core dryers, powder handling systems, clean rooms, support facilities, and tank farms
  • Strong business maturity and interpersonal skills
  • Excellent communication and collaboration skills
  • Proven attention to detail and organization in project work
  • GMP and Good Documentation Practice training
  • Intermediate skills with WORD, EXCEL, and PowerPoint
Benefits

Verista offers a competitive salary, performance-based incentive programs, company-paid life, short-term, and long-term disability insurance, medical, dental, and vision insurance, FSA, DCARE, commuter benefits, supplemental life, hospital, critical illness, and legal insurance, health savings account, 401(k) retirement plan, paid time off, holidays, as-needed sick time, tuition reimbursement, team social activities, employee recognition, employee referral program, paid parental leave, and bereavement leave.



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