This role provides critical technical and operational support within a GMP manufacturing environment. The successful candidate will focus on deviation management, documentation authorship, and continuous improvement projects to ensure process efficiency, regulatory compliance, and safety. This position bridges the gap between on-the-floor operations and technical engineering, requiring strong collaboration across cross-functional teams to resolve complex issues and keep projects moving on schedule.
Key Responsibilities- Deviation & Investigation Management: Support deviation investigations, assess product impact, determine root cause, and establish Corrective and Preventive Actions (CAPAs) and quality incident reports.
- GMP Documentation & Authorship: Author, update, and lead revisions for standard operating procedures (SOPs), batch records, change control documents, technical protocols, and validation records.
- On-the-Floor Technical Support: Provide real-time, on-the-floor support for complex operational, equipment, and process issues, looking at challenges through multiple lenses (safety, compliance, automation, and people).
- Project Management & Execution: Complete and lead projects aimed at improving Right-First-Time performance, reducing deviations, lowering costs, and supporting equipment/facility initiatives in Sterile Supply areas.
- Timeline Oversight: Manage project schedules to ensure compliance and customer deadlines are met, proactively escalating potential delays and developing remediation plans.
- Cross-Functional Partnership: Partner effectively with Operations, Quality, Planning, Automation, Maintenance, and external vendors to achieve safety and compliance objectives.
Qualifications & RequirementsEducation & General Experience- Degree: B.S. or B.A. in Engineering, Sciences, or a related technical discipline.
- Experience: 2-4 years of experience (a combination of co-op/internship and real-world industrial experience is acceptable).
Core Skills- Technical Writing: Strong technical writing skills with the ability to draft clear, precise GMP documentation.
- Communication & Leadership: Highly developed communication, leadership, and teamwork skills.
- Time Management: Proven ability to manage projects and successfully work to tight schedules and deadlines.
Preferred Experience & Skills (A Plus)- Previous experience with Deviation Management Investigations and Root Cause Analysis.
- Experience working in a biologics, vaccine, or bulk sterile manufacturing environment.
- Familiarity with Change Control processes.
- Ability to thrive and meet hard deadlines in a fast-paced environment.
- Any prior experience using SAP and/or Power BI is beneficial.
