Sr. Manager Engineering and Maintenance at Simtra BioPharma Solutions

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 teamsso we can solve problems in new ways.Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 Sr. Manager of Engineering & Maintenance (E&M) leads a team of Process Engineers Maintenance personnel and Equipment Coordinators to support all aspects of secondary packaging for parenteral pharmaceutical products. This position is part of a cell-based building management structure complimented by peer leaders from Operations Quality and Technical Services departments. The incumbent will be responsible for leading a department with foundational expectations centered on safety quality execution collaboration and process improvement to support cell operational metrics and overall plant goals & objectives. The position reports to the Associate Director Engineering & Maintenance Operations.The responsibilities:Responsible for maintaining departmental headcount and all associated administrative and planning functions including interviewing candidates hiring onboarding & training personnel development performance management scheduling directing day-to-day activities and project oversightResponsible for equipment performance preventive/scheduled maintenance emergency maintenance vendor scheduling and project management - including timely repair and sourcing of critical parts or componentsResponsible for coordinating all activities and/or repairs related to facilities maintenance for buildingResponsible for Total Productive Maintenance (TPM) program focused on identifying overall equipment efficiencies to enhance production processes and qualitySupports identification and procurement activities related to new process equipment. Includes generation of user specification documents installation commissioning and qualification activities Provides oversight and management for process engineers regarding project ownership including collaboration with CAPEX project engineers and project timelinesWorks closely with peer cell leaders towards common goals to track and report department specific metrics within the cellResponsible for identification and implementation of corrective actions to improve performance and complianceComplies with Standard Operating Procedures (SOPs) Current Good Manufacturing Practices (cGMP) and rigorous quality standards and holds team to same expectationMaintains a clean and safe work area using 6S (6 Sigma) principlesEnsures team is compliant with safe work practices and electrical requirements including LOTO (Lock Out Tag Out) safe work permits and all Personal Protective Equipment (PPE) required to safely complete assigned workLead and/or support a variety of complex issues & projects as applicableApply technical expertise and troubleshooting philosophies with a variety of technologies including: syringe & vial aseptic filling machines and related process equipment autoclaves lyophilizers terminal sterilizers isolator systems Human Machine Interface (HMI) PLCs clean utilities HVAC SCADA systems and electrical control systemsAbility to troubleshoot complex automated machinery and manual/mechanical based equipment or applicationsFully accountable for the performance of self and teamRequired qualifications:BS degree in Engineering or a related field of study7 years of manufacturing experiencePrior experience and familiarity working in a cGMP environment3 years of leadership / supervisory experienceDemonstrated examples of successful project executionTrack record in technical management of process equipment in a manufacturing environment with experience in electrical mechanical and automated applicationsAble to analyze and solve complex problemsKnowledge of GMPs FDA guidelines purchasing practices and process validationTeam building experience in guiding multi-disciplinary teams on medium complexity issues while providing technical direction to individual engineering disciplinesAbility to translate business goals into action plansUnderstanding and proficiency in reliability-centered maintenance principles and practiceResults-oriented mindset capable of independent thought adaptable ready to respond and react to real-time situations with realistic and viable technical organizational and administrative solutionsAdvanced proficiency in Microsoft Office SuiteAbility to utilize enterprise software applications: Maximo Veeva Microsoft Dynamics Blue MountainAbility to communicate effectively and professionallyAbility to write and review technical documentsDemonstrated efficient written and verbal communication skillsMinimal travel required (less than 10%) including potentially supporting equipment FATAbility to apply and utilize Root Cause Analysis (RCA) toolsPhysical / safety requirements:Ability to stand or sit for extended periods of timeAbility to utilize required personal protective equipment (PPE)Dexterity and physical condition to perform some level of repetitive motion tasksIn return youll be eligible for1: Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life InsuranceShort and Long-Term Disability 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 BenefitsVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit Union1 Current benefit offerings are in effect through 12/31/25DisclaimerThis 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 Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy: Experience:Manager Key Skills Hospitality Experience,Go,Management Experience,React,Redux,Node.js,AWS,Mechanical Engineering,Team Management,Leadership Experience,Mentoring,Distributed Systems Employment Type : Full Time Experience: years Vacancy: 1