Science and Compliance Specialist, Weekend PM

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. This role: 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. Schedule: Friday-Sunday 7:00pm-7:30am The 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 toolsInvestigate the root cause(s) of the issue and document the investigation resultsEnsure the Investigation record is maintained with current and accurate information throughout its lifecycleCollaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectivenessManage multiple investigations simultaneously, ensuring timely progression and compliance with deadlinesRepresent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting dataReview and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiencyPartner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process performanceServe as an operations subject matter expert (SME), providing technical guidance on process performance, aseptic practices, and equipment operationDraft, revise, and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy, clarity, and compliance with regulatory expectations Required qualifications: BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience2+ years technical writing experience, preferably in pharmaceutical industryMust have knowledge of GMPs and worldwide regulatory agency guidelines.Knowledge of applicable CAPA procedures, specifications, regulations and standardsMicrosoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiencyGoal-setting, prioritize, organization, attention to detail, and time management skillsCritical & creative thinking and problem-solving skillsAbility to use logic and scientific principles to reach conclusions when presented with ambiguous dataStrong oral and written communication skillsAbility to demonstrate strong leadership skillsKnowledge of FDA regulations and application of Good Manufacturing Practices (GMP)Ability to utilize enterprise software systems (Veeva) Physical / safety requirements: Duties will require overtime work, including nights and weekends on occasionAbility to gown in C/D gowning area In return, you’ll be eligible for[1]: Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life Insurance401(k) Retirement Savings Plan with Company MatchTime Off ProgramPaid HolidaysPaid Time OffPaid Parental Leave and moreAdoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service ProgramEmployee Ownership PlanAdditional BenefitsShort and Long-Term Disability InsuranceVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit Union [1] Current benefit offerings are in effect through 12/31/26 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Equal Employment Opportunity Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/