Senior Manager Engineering & Maintenance - Packaging

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.

This role:

The Manager of Engineering & Maintenance leads a team of Process Engineers and Maintenance personnel (Supervisor and Technicians) to support all aspects of secondary packaging for parenteral pharmaceutical products. This senior level 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 Director of Operations.

The responsibilities:

• Lead a team of process engineers and maintenance personnel assigned to support all aspects of product inspection, labeling, and packaging
• Maintaining departmental headcount and all associated administrative and planning functions. Includes 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. Timely repair and sourcing of critical parts or components. Spare part inventory management.
• Coordinate all activities and/or repairs related to facilities maintenance for Building.
• Support identification and procurement activities related to new process equipment. Includes generation of user specification documents, installation, commissioning, and qualification activities.
• Oversight and management for process engineers regarding project ownership, Capex management, and project timelines.
• Track and report department specific metrics within the cell. Responsible for identification and implementation of corrective actions to improve performance and compliance.

The work environment:

Complies with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), and rigorous quality standards. Holds team to same expectation. Sustain a clean and safe work area using 6S 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 required to safely complete assigned work.

Desirable qualifications:

• Bachelor's Degree in relevant field of study.
• Minimum 8 years manufacturing experience required, preferably in a cGMP environment
• Minimum 5 years required in a leadership role.
• Knowledge of GMPs, FDA guidelines, purchasing practices and process validation.
• Computer proficiency. Utilize enterprise software applications: Maximo, TrackWise. Veeva, Microsoft Dynamics, Microsoft Office applications.
• An understanding and proficiency in reliability-centered maintenance principles and practices.

Physical / safety requirements:

• Stand or sit for extended periods of time
• Utilize required personal protective equipment
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Use of hands and fingers to manipulate office equipment is required
• Duties may require extended work hours, including nights and weekends
• Minimal travel required (less than 10%) Support equipment FAT as necessary

Additional requirement(s):

• Demonstrated examples of successful project execution
• A track record in technical management of process equipment in a manufacturing environment, with experience in electrical, mechanical, and automated applications. Capable of analyzing and solving complex problems
• Team building experience in guiding multi-disciplinary teams on medium complexity issues, while providing technical direction to individual engineering disciplines.
• Translate business goals into action plans.
• Apply and utilize Root Cause Analysis (RCA) tools.
• A 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.

In return, you'll be eligible for[1]:

• 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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