Simtra BioPharma Solutions
Sr. Manager, Engineering and Maintenance
Bloomington, Indiana, United States · Senior
Sponsorship not specifiedDetected 12 days ago
ReactProject ManagementProcess ImprovementProcurementPerformance ManagementControlsGMPFDA RegulatoryLeadershipCommunicationCollaborationAdaptabilityMicrosoft OfficeSCADAHMI
About the role
- 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.
- 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.
Responsibilities
- Responsible for coordinating all activities and/or repairs related to facilities maintenance for building
- Supports 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 timelines
- Maintains a clean and safe work area using 6S (6 Sigma) principles
- Lead and/or support a variety of complex issues & projects as applicable
- 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.
- 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.
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- BS degree in Engineering or a related field of study
- 7+ years of manufacturing experience
- 3+ years of leadership / supervisory experience
- Track record in technical management of process equipment in a manufacturing environment, with experience in electrical, mechanical, and automated applications
- Knowledge of GMPs, FDA guidelines, purchasing practices and process validation
- Ability to translate business goals into action plans
- Understanding and proficiency in reliability-centered maintenance principles and practice
- Advanced proficiency in Microsoft Office Suite
- Ability to stand or sit for extended periods of time
- Ability to utilize enterprise software applications: Maximo, Veeva, Microsoft Dynamics, Blue Mountain
Benefits
- 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.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
Company info
- 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.
- While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
- This position is part of a cell-based building management structure, complimented by peer leaders from Operations, Quality, and Technical Services departments.
Equal 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.
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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.