We are looking for 25 Manufacturing and Investigations Specialists to support biologics manufacturing at our Puerto Rico site.
You will investigate manufacturing deviations, drive root cause analysis and CAPA, serve as an equipment SME, and own the procedures and technical documentation behind cell culture and drug substance purification operations. The work is hands-on, floor-facing, and directly visible to Quality leadership and regulators.
We are hiring across shifts and process areas, with clear paths into SME and lead roles.
Key Responsibilities
Manufacturing & Equipment Support
- Initiate, revise, and approve manufacturing procedures.
- Assess performance of floor operations and review performance data. Develop process improvement opportunities.
- Serve as an equipment Subject Matter Expert (SME) and support CMMS activities, preventive maintenance strategies, work orders, spare parts, reliability, and equipment performance.
- Monitor equipment metrics such as availability and downtime and lead improvement opportunities to increase reliability and reduce manufacturing interruptions.
- Provide technical troubleshooting and support equipment, automation, and process modification projects.
- Evaluate manufacturing and equipment performance data and implement Lean Manufacturing and continuous improvement opportunities.
- Support process qualification activities, functional testing, water testing, engineering runs, and campaign readiness.
- Create, revise, and approve manufacturing procedures; serve as document owner and support MBR creation and revisions.
- Develop technical protocols, investigation documentation, and training materials in compliance with cGMP and GDP.
- Provide technical training and collaborate with cross-functional teams on manufacturing improvements and special projects.
Non-Conformance and CAPA Support
- Author, execute, and manage non-conformances and CAPAs.
- Monitor and communicate incident trends.
- Participate in regulatory inspections.
Preferred Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred.
- Experience in biotechnology, pharmaceutical, or other regulated manufacturing environments.
- Experience with biotechnology operations
- Preferred experience in Cell Culture and Drug Substance Purification.
- Strong knowledge of GMP, GDP, manufacturing investigations, Deviation lifecycle management, CAPA, Change Control, and Root Cause Analysis.
- Knowledge of RCA methodologies including Fishbone (Ishikawa), 5 Whys, Kepner-Tregoe, and Six Boxes.
- Experience with manufacturing equipment, automation, equipment reliability, troubleshooting, and Lean Manufacturing would be a plus.
- Strong technical writing, analytical, problem-solving, and communication skills in English and Spanish.
- Familiarity with TrackWise, Veeva, MES, SmartSheet, Power BI, Spotfire, CDOCS, CMMS, and process monitoring platforms.
Pay: $30.00 - $40.00 per hour
Work Location: In person
