Science and Compliance Specialist

Simtra BioPharma Solutions•Bloomington, IN

About The Position

The Science and Compliance Specialist serves as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs and controlled documents, and supporting production teams through troubleshooting, process optimization, and documentation accuracy. The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root causes, maintain accurate cGMP compliant records, and drive effective CAPA implementation. It requires managing multiple investigations simultaneously and supporting audits by clearly communicating findings.

Requirements

BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience
2+ years technical writing experience, preferably in pharmaceutical industry
Must have knowledge of GMPs and worldwide regulatory agency guidelines.
Knowledge of applicable CAPA procedures, specifications, regulations and standards
Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
Goal-setting, prioritize, organization, attention to detail, and time management skills
Critical & creative thinking and problem-solving skills
Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
Strong oral and written communication skills
Ability to demonstrate strong leadership skills
Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
Ability to utilize enterprise software systems (Veeva)
Duties will require overtime work, including nights and weekends on occasion
Ability to gown in C/D gowning area

Responsibilities

Lead and execute investigations for deviations, including defining scope, applying structured problem‑solving methods, and documenting results in compliance with cGMP standards.
Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
Investigate the root cause(s) of the issue and document the investigation results
Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness
Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines
Represent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting data
Review and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiency
Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process performance
Serve as an operations subject matter expert (SME), providing technical guidance on process performance, aseptic practices, and equipment operation
Draft, revise, and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy, clarity, and compliance with regulatory expectations