Computer Systems Validation Associate II
For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.The Validation Associate II is a key member of the Computer Systems Validation team within the Technical Services organization. The Validation Associate II must have a working knowledge of the overall requirements dictated by worldwide regulatory agencies with respect to computer systems validation. This position works directly with the Information Technology department and other functional areas and is considered the lead validation resource. The Validation Associate II understands industry best practices and maintains a state of audit readiness always. This position reports to the Manager, Computer Systems Validation.What You'll Be DoingValidation document author/reviewer – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templatesTechnical writing proficiency – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates.Entitlement Reviews – Coordinates user access reviews for recertification and authorizationLocal Change Control ownerCSV periodic reviews – to maintain the validated state, the Associate will perform periodic reviews of validation packages per established proceduresValidation lead GAMP Category 1 - 4Client audits – The Associate will participate in client audits, responding verbally to auditor’s questions.Global Change Control task ownerSystem assessments – Quality, Regulatory, Risk, Gap CAPA ownerNCR/SNCR investigatorValidation Lead for implementation of major and minor software applications or modules for Good Manufacturing Practices (GMP) useCompletes detailed risk assessment and 21 CFR part 11 Gap analysisMaintains departmental compliance with regulations and corporate proceduresCoordinates computer systems implementation activities with Vendors and other non-BPS resourcesCreates/Reviews validation documentation, templates, procedures, and all documentation generated during a computer systems validation projectParticipates in Internal/Client/Corporate AuditsRepresents validation department as validation expert in cross-functional work teamsAdvocates and understands best practices for system validations and processesArticulates complex systems and communicates to technical and nontechnical managementWhat You'll BringBS in Electronic or Software Engineering, Information Systems, or a related field, preferred3+ years experience of working within a regulated environment (worldwide regulatory agencies), particularly in computer systems validation or other validation disciplineAbility to use enterprise software (i.e., ERP, EDMS, QMS, JDE, Trackwise, etc.)Experience with Microsoft ProjectTechnical writing skillsPhysical / Safety RequirementsDuties may require overtime work, including nights and weekendsUse of hands and fingers to manipulate office equipment is requiredPosition requires sitting for long hours, but may involve walking or standing for periods of timeIn 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 ProgramAdditional 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 12/31/26DisclaimerThis 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 OpportunitySimtra 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 PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/