CMMS Administrator

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 Computerized Maintenance Management System (CMMS) Administrator is responsible for maintaining and overseeing the CMMS system, including training and system access. The CMMS Administrator will collaborate with applicable departments to create and track work orders (WO) and associated tasks in order to support batch release and CAPA closure. This role will report to the Director of Maintenance and Reliability, and it is a hybrid position at our Bloomington, Indiana facility.

The responsibilities:

• Subject Matter Expert of the CMMS system and will provide training to internal stakeholders/users and manage the access to the system
• Collaborate with Action Owners/Approvers and facilitate the resolution of work order backlog
• Provides oversight to work order completion for batch release/CAPA closure
• Amends and maintains standard operating procedures (SOPs) and supports system updates/upgrades
• Supports facility Fit and Finish program and ensures adherence to schedule
• Generate work order report and present site metrics to leadership and at the quarterly Quality Review meeting
• Responsible for speaking to client auditors and regulatory personnel to explain work order process and the CMMS system

Required qualifications:

• Associates (AS) Degree
• 5 years experience with work order, preventive maintenance, and/or inventory systems
• Advanced proficiency in Microsoft Office Suite (Word, Excel, Outlook)
• Preferred experience in Maximo, Dynamics 365, and/or TrackWise
• Excellent attention to detail and organization skills
• Strong oral and written communication skills
• Strong leadership skills with the ability to persuade, influence, and negotiate
• Experience in a regulated industry, preferably knowledge of FDA regulations current Good Manufacturing Practices (cGMP)
• Must be able to work overtime, including nights, weekends, and during facility shutdowns

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
• 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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