Overview
This role is critical to maintaining compliance with cGMP and regulatory requirements by leading equipment- and process-related investigations, supporting operational excellence, and driving continuous improvement.
You will play a key role in ensuring quality and compliance across sterile manufacturing systems such as lyophilizers, vial washers, filling lines, HVAC, and WFI systems.
Key Responsibilities
- Lead full-cycle investigations of equipment and facility deviations-from initiation to resolution and closure-ensuring timely, compliant, and thorough documentation.
- Author technically sound deviation reports focused on sterile manufacturing systems (e.g., lyophilizers, vial washers, HVAC, WFI).
- Collaborate cross-functionally with Engineering, Facilities, QC, Microbiology, Supply Chain, and Manufacturing to troubleshoot issues, determine root causes, and develop effective CAPAs.
- Ensure all investigations comply with FDA, cGMP, and internal SOPs.
- Manage deviation records using TrackWise and Oracle EAM, with future migration to SAP.
- Provide guidance on GMP requirements for sterile manufacturing, particularly around cleanroom environments, humidity control, and environmental systems.
- Identify recurring issues and contribute to preventive strategies to reduce deviation frequency and improve audit readiness.
- Support regulatory inspection readiness and assist with internal and external audits.
Qualifications
- Bachelor's degree in Engineering, Biology, Life Sciences, or related field.
- 3+ years of experience in engineering, quality, or compliance roles within a GMP-regulated manufacturing environment (preferably sterile/aseptic).
- Proven track record of independently managing and completing deviation investigations.
- Strong technical knowledge of pharmaceutical manufacturing equipment and systems.
- Experience with deviation and quality management systems such as TrackWise, Oracle EAM, or SAP.
- Proficiency with root cause analysis tools (5 Whys, Fishbone Diagram, 6Ms, etc.).
- Excellent technical writing and documentation skills.
Preferred Qualifications
- Experience in fill/finish operations or with sterile manufacturing equipment.
- Previous involvement in preparing for regulatory audits (e.g., FDA).
- Familiarity with environmental and utility systems (HVAC, WFI, cleanroom systems).