Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control

Responsibilities

• Deviation Ownership & Execution
• Demonstrated technical writer able to articulate complex events into concise and clear documentation that is inspection ready.
• Advanced thinker who, with some oversight from management and mentors, is able to structure investigational workflows with cross-functional team members that help drive teams to sound, data-driven conclusions and 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.
• 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.
• CAPA Development & Effectiveness
• Lead CAPA identification and development aligned with investigation outcomes.
• Support CAPA 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.
• Data Analysis & Continuous Improvement
• Provide inputs to: Deviation trending, Data analysis for recurring issues, Identify and share opportunities for prevention strategies and contamination control improvements, Leverage AI and digital tools compliantly to streamline investigation processes.

Qualifications

• High school diploma/GED and 4 years of manufacturing and/or operations experience.
• Associates degree and 2 years of manufacturing and/or operations experience.
• Bachelor's degree and 6 months of manufacturing and/or operations experience.
• Masters degree.
• Preferred: BS/BA or equivalent (science/engineering/psychology preferred) and 2+ years of experience in the pharmaceutical industry.
• Experience applying AI or other digital tools to generate insights and streamline workflows.