TOLMAR Inc. Senior Validation Engineer in Windsor, Colorado
Purpose and ScopeResponsible for the support, development, execution, and coordination ofvalidation activities including, commissioning and leveraging,qualification, and validation of computerized and non-computerizedmanufacturing equipment and systems.Essential Duties and ResponsibilitiesCoordination and execution of activities to qualifyComputerized and automated systemsHighly customized, automated skids with multiple unit operationsPowder fillerIsolator and RABS equipmentSterilization process equipment (Autoclaves, Dry Heat Ovens, ProcessSIP, VPHP)Lyophilization systemsCleaning processes (CIP/COP) andAseptic process simulationsProvide validation input to Engineering and Maintenance in equipment purchaserequirements and FAT and SAT.Develop and approve change controls, validation plans, qualificationprotocols, equipment related design documents URS, FS, DQ and SDS, aswell as associated reports and procedures.Direct experience providing technical assessments for proposed changes tovalidation process to identify requirements necessary to maintain validationstatus.Collaborate with site staff and QAV on the development and improvement of CSVand non-CSV related SOPs, work instructions and forms.Maintain and manage re-qualification schedules.Support validation of laboratory computerized systems (including customdeveloped software and cloud based applications) and equipment.Additional duties as assigned.Core ValuesThe Senior Validation Engineer is expected to operate within the framework ofTolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,and take action with great speed and efficiency no matter the task.Knowledge, Skills and AbilitiesDemonstrated experience in multiple validation areas with an emphasis oncomplex systems.Experience in GAMP 5 methodology for commissioning and qualification ofequipment and computerized systems. Knowledge and understanding of risk based approach for validation, e.g.leveraging or applied commissioning. Extensive GMP compliance knowledge including 21 CFR Parts 11, 210,211, and 820 requirements, Data Integrity, ICH Q7A, EU GMP Annex 1 andEU Annex 11 requirements, and PDA and ISPE guides.Experienced with validation tools e.g., Kaye Validator and ElLab.Proficiency in documentation systems, e.g., VeevaProficiency in writing validation protocols and reports.Strong technical skills and the ability to understand technical documentationsuch as equipment manuals or PandIDs.Ability to manage multiple projects simultaneously.Ability to work effectively both independently and in conjunction with a team.Demonstrated strong leadership working on complex tasks with minimaloversight.Serve as a mentor to junior validation associates. Education and ExperienceBachelor's degree in Engineering or Science related field.Minimum 5 years of extensive pharmaceutical validation experience required.Compensation and BenefitsAnnual pay range $115,000 - $125,000Link to general benefits information:https://www.tolmar.com/careers/employee-benefitsBonus eligibleWorking ConditionsWorking conditions are normal for an office environment.Work may require occasional weekend and/or evening work.Work inside manufacturing clean rooms where gowning is required.