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 Maintenance Supervisor - Facilities Leader of a high-performance maintenance team responsible for supporting daily manufacturing operations and equipment in an aseptic, sterile environment.

 

The responsibilities:

  • Responsible for implementing and supervising daily maintenance activities in the production or facility areas to ensure manufacturing goals and projects deadlines are met while maintaining compliance with current Good Manufacturing Practices
  • Manage, identify, hire, develop, and recognize technical staff; team may include senior level maintenance technicians
  • Provide technical direction to staff and internal customers
  • Identify/prioritize/provide resources to assist the department manager to meet the annual operating plan and budgetary commitments
  • Emphasize training and implement control systems on multiple shifts to complete all PM's on time
  • Commit to employee feedback and developmental processes
  • Provide a positive and equitable working environment emphasizing the Simtra values
  • Support and emphasize the Safety and Quality commitments of the department
  • Investigate and resolve disciplinary issues up to and including suspensions and terminations
  • Ensure alignment of maintenance priorities and resources to evolving business needs
  • Responsible for spare part analysis and inventory development
  • Assist in the installation and startup of new equipment
  • Has or is able to achieve Aseptic 10K Gowning Certification.
  • Comply with state, federal and corporate Safety and Environmental regulations

 

The work environment:

  • May be required to stand for over 4 hours 
  • Duties may require overtime work, including nights and weekend

 

Desirable qualifications:

  • BS/BA degree in an engineering or science discipline with 5+ years industrial maintenance experience 
  • Completion of an accredited apprenticeship program (by presenting a certificated issued by the Department of Labor) with 10+years of industrial/manufacturing/equipment maintenance experience
  • 15+ years of industrial/manufacturing/equipment maintenance experience in lieu of degree/completion of apprenticeship program (with notarized letters from previous employers, as applicable)
  • Intermediate (or higher) proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
  • Experience in enterprise software (i.e., JDE, BPLM, Pilgrim, Trackwise, etc.)

 

Physical / safety requirements:

  • Must be able to life, push/pull, and carry up to 50 lbs
  • Must be able to lift 20 lbs overhead
  • Occasionally required to lift and/or move objects weighing up to 100 lbs
  • Must be able to wear personal protective equipment, including respirator
  • Use of hands and fingers to manipulate office equipment and hand tools is required

 

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 12/31/2024

 


 

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.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

 

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

 

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