Sr. Manager Engineering and Maintenance

Simtra BioPharma Solutions•Bloomington, IN

26d

About The Position

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. 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.

Requirements

BS degree in Engineering or a related field of study
7+ years of manufacturing experience
Prior experience and familiarity working in a cGMP environment
3+ years of leadership / supervisory experience
Demonstrated examples of successful project execution
Track record in technical management of process equipment in a manufacturing environment, with experience in electrical, mechanical, and automated applications
Able to analyze and solve complex problems
Knowledge of GMPs, FDA guidelines, purchasing practices and process validation
Team building experience in guiding multi-disciplinary teams on medium complexity issues, while providing technical direction to individual engineering disciplines
Ability to translate business goals into action plans
Understanding and proficiency in reliability-centered maintenance principles and practice
Results-oriented mindset, capable of independent thought, adaptable, ready to respond and react to real-time situations with realistic and viable technical, organizational, and administrative solutions
Advanced proficiency in Microsoft Office Suite
Ability to utilize enterprise software applications: Maximo, Veeva, Microsoft Dynamics, Blue Mountain
Ability to communicate effectively and professionally
Ability to write and review technical documents
Demonstrated efficient written and verbal communication skills
Minimal travel required (less than 10%), including potentially supporting equipment FAT
Ability to apply and utilize Root Cause Analysis (RCA) tools
Ability to stand or sit for extended periods of time
Ability to utilize required personal protective equipment (PPE)
Dexterity and physical condition to perform some level of repetitive motion tasks

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 oversight
Responsible for equipment performance, preventive/scheduled maintenance, emergency maintenance, vendor scheduling, and project management - including timely repair and sourcing of critical parts or components
Responsible for coordinating all activities and/or repairs related to facilities maintenance for building
Responsible for Total Productive Maintenance (TPM) program focused on identifying overall equipment efficiencies to enhance production processes and quality
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
Works closely with peer cell leaders towards common goals to track and report department specific metrics within the cell
Responsible for identification and implementation of corrective actions to improve performance and compliance
Complies with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), and rigorous quality standards and holds team to same expectation
Maintains a clean and safe work area using 6S (6 Sigma) principles
Ensures 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 work
Lead and/or support a variety of complex issues & projects as applicable
Apply 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 systems
Ability to troubleshoot complex automated machinery and manual/mechanical based equipment or applications
Fully accountable for the performance of self and team