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MS&T Specialist – Deviations Investigator
Job Location:
Hourly Salary:
Posted:
29 September 2026 (4 days ago)
Posted:
Application Deadline:
27 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Our Client a Pharmaceuticals company is looking for a MS&T Specialist Deviations Investigator for their Davie FL location.
Responsibilities:
Requirements:
Why Should You Apply
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any status protected by applicable law.
Responsibilities:
- All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
- 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).
Requirements:
- Any equivalent combination of education training and/or experience that fulfills the requirements of the position will be considered.
- Masters 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.
- Minimum Masters degree
Why Should You Apply
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any status protected by applicable law.
Required Experience:
IC
