MS&T Specialist – Deviations Investigator

ICONMA•Davie, FL

10d•Onsite

About The Position

Our Client, a Pharmaceuticals company, is looking for a MS&T Specialist – Deviations Investigator for their Davie, FL location. This role involves leading and co-authoring cGMP investigations for OSD manufacturing and complex operations, ensuring clear problem statements, accurate timelines, and timely closure. The specialist will coordinate event triage, immediate actions, and support batch disposition decisions. They will collect, organize, and analyze manufacturing, engineering, and laboratory evidence to establish event sequences and contributing factors. Additionally, the role requires facilitating cross-functional root cause analysis using structured tools, documenting conclusions, and defining/tracking CAPAs. The specialist will also prepare investigation/CAPA records, support trending and continuous improvement, and participate in audit/inspection readiness.

Requirements

Master’s or Ph.D. degree in a scientific or engineering discipline with relevant experience supporting investigations within pharmaceutical manufacturing, engineering, and/or QC laboratories; oral solid dosage (OSD) experience preferred.
Experience using electronic quality systems and manufacturing/laboratory data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) to support investigations, trending, and effectiveness monitoring preferred.
OSD manufacturing and complex process/equipment knowledge sufficient to investigate events across Production, Engineering, and QC (e.g., blending, granulation, compression, coating, encapsulation, and supporting utilities).
Strong Technical writing and documentation skills (deviations/nonconformances, OOS/OOT as applicable, product impact assessments, CAPA, and effectiveness checks) using Good Documentation Practices (GDP).
Knowledge of cGMP, pharmaceutical quality systems, and data integrity expectations applicable to investigations, CAPA, and inspection readiness.
Analytical and problem-solving capability using structured root cause analysis tools (e.g., 5-Why, fishbone, fault tree) to separate symptoms from true root causes.
Ability to interpret and trend manufacturing/equipment/lab data using available systems and tools (e.g., eQMS, MES, LIMS, historian/trending tools, Excel/dashboards) to support risk-based decisions.
Effective cross-functional facilitation and communication skills, including managing multiple investigations, aligning stakeholders, and clearly presenting complex technical information.
Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
Seeks out all resources when selecting methods and techniques for obtaining results.
Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
Able to identify solutions to general problems through collaboration and creativity.
This role will focus heavily on internal troubleshooting within Client and require frequent cross-functional collaboration.
The individual should be confident in navigating conversations across teams, with strong negotiation skills and the ability to communicate effectively and proactively.

Nice To Haves

Oral solid dosage (OSD) experience preferred.
Experience using electronic quality systems and manufacturing/laboratory data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) to support investigations, trending, and effectiveness monitoring preferred.

Responsibilities

Lead and/or co-author cGMP investigations for OSD manufacturing and complex operations (deviations/nonconformances/atypical events), ensuring clear problem statements, accurate timelines, and timely closure in the quality system.
Coordinate event triage and immediate actions, including containment and escalation, and support batch disposition decisions with Operations, Engineering, QC, and QA.
Collect, organize, and analyze manufacturing, engineering, and laboratory evidence (e.g., batch records, equipment/maintenance logs, MES/SCADA/historian data, calibrations, environmental monitoring, and test results) to establish event sequence and contributing factors.
Facilitate cross-functional root cause analysis using structured tools (e.g., 5-Why, fishbone, fault tree as applicable) and document technically sound, compliant conclusions and product impact assessments.
Define, document, and track CAPAs (correction/corrective/preventive actions) with appropriate due dates and effectiveness checks; support on-the-floor verification and implementation to prevent recurrence.
Prepare clear, complete investigation/CAPA records; support trending and continuous improvement; and participate in audit/inspection readiness by providing evidence packages and responses (while maintaining required training and safe work practices).