Specialist Manufacturing Deviation Owner Environmental and Contamination Control

Responsibilities

• Advanced technical writer who can articulate complex events into concise, clear, and contemporaneous documentation that is inspection ready.
• Critical thinker who is able to structure investigational workflows with cross-functional team members that help drive teams to sound, data-driven conclusions that advance deviation records forward.
• Serve as the designated owner for deviation records (initial job scope may focus on Environmental and Contamination Control; however, scope can be across manufacturing events).
• Ensure timely progression and closure of deviations.
• Maintain accountability for data integrity and completeness of records.
• Provide mentorship/coaching to more junior deviation owners.
• Investigation & Root Cause Analysis:
  • Define and execute investigation strategy.
  • Conduct shopfloor observations and Gemba activities, including interviews.
  • Develop, schedule, and execute root cause analyses (RCA) and ensure scientific justification of conclusions.
  • Lead CAPA development and effectiveness verification (EV) management activities.
• Cross-Functional Coordination:
  • Work with various organizations across the site and network including the Contamination Control Lead, Contamination Control Network, process specialists, Quality Assurance (QA), QC / microbial experts, Process Development, and Facilities and Engineering.
  • Ensure appropriate functional input into investigations and decisions.
• Documentation & Decision-Making:
  • Drive strategic decision making for deviation documentation updates.
  • Support change control impact assessments where deviations trigger system/process changes.
• Regulatory & Inspection Interface:
  • Act as primary SME during inspections for assigned deviations.
  • Be prepared to defend investigation rationale and classification decisions.
  • Participate in daily updates / inspector engagements when required.
• Data Analysis & Continuous Improvement:
  • Support: Deviation trending.
  • Data analysis for recurring issues.
  • Identify and help to implement prevention strategies and contamination control improvements.
  • Leverage AI and digital tools compliantly to streamline investigation processes.

  Qualifications

  • High school diploma/GED and 10 years of directly related experience OR Associates degree and 8 years of directly related experience OR Bachelors degree and 4 years of directly related experience OR Masters degree and 2 years of directly related experience OR Doctorate degree.
  • BS/BA or equivalent (science/engineering/psychology preferred) and 8+ years of experience in the pharmaceutical industry.
  • Experience applying AI or other digital tools to generate insights and streamline workflows.