Sr. Manager Engineering and Maintenance

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 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

Required qualifications:

• 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

Physical / safety requirements:

• 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

In return youll be eligible for1:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

1 Current benefit offerings are in effect through 12/31/25

Disclaimer

This 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 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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