Equipment Coordination Supervisor

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 Equipment Coordination Supervisor is a key member of a high-performance team responsible for supporting daily manufacturing operations and equipment in an aseptic, sterile environment. This position reports to the Senior Manager, Engineering and Maintenance and functions as the supervisor over the equipment coordinators.

Theresponsibilities:

* Responsible for implementing and supervising daily activities related to equipment coordination to ensure manufacturing goals and projects are met while maintaining compliance with current Good Manufacturing Practices.
* Issue and track all product contact equipment for all GMP production batches as well as for non-GMP batches and testing activities.
* Manage inventory for all productcontact equipment, including monitoring equipment condition, coordinating repairs, and initiating procurement of new equipment or spare parts as required.
* Maintain accurate equipment lifecycle data and status updates in Microsoft Dynamics 365, ensuring traceability and documentation accuracy.
* Serialize, passivate, and etch all new equipment and enter equipment asset into Microsoft Dynamics 365 software package.
* Partner with Technical Services to ensure availability and readiness of equipment for new product introductions, process modifications, and projectrelated changes.
* Review all manufacturing batch records and equipment project plans.
* Support documentation and changecontrol activities related to equipment, ensuring alignment with internal quality standards and regulatory expectations.
* Participate in spare part analysis and inventory development.

Required qualifications:

* High school diploma or GED required. Associates degree preferred.
* Minimum 2 years of industrial manufacturing, maintenance or engineering experience required.
* Minimum 1 year of leadership experience required.
* Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Dynamics, Trackwise, etc.)

Physical / safety requirements:

* Must be able to lift, push/pull, and carry up to 50 pounds
* May be required to stand for over 4 hours per day
* Must be able to lift 20 pounds overhead
* Must be able to wear personal protective equipment, including respirator
* Must be able to qualify for entry into Grade C Manufacturing area.
* Duties may require overtime work, including nights and weekends

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
    
    
    
    
  • 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
  
  
  
  • Short and Long-Term Disability Insurance
  
  
  
  
  • 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 12/31/26

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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