Lyophilization Technician (Weekend AM Shift)

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.

The Lyophilization Technician is primarily responsible for the preparation of lyophilizers, execution / use of the automated loading and unloading system, and appropriate control and monitoring of the lyophilization cycle. Secondary responsibilities include cross-training in other Manufacturing departments on other production-related equipment and processes. This position reports to the Lyo Supervisor.

• →Monitors each lyophilizer during operation via appropriate checks and documentation.
• →Performs all aspects of lyophilization preparation such as Clean in Place (CIP), Steam in Place (SIP), and leak tests.
• →Troubleshoots or repairs mechanical failures / faults with the lyophilization systems.
• →Coordinates with the Maintenance, Engineering, Chemistry, Quality, R&D, Technical Services, and outside vendors to implement new client cycles / cycle updates, mechanical readiness of the lyophilizers, and troubleshooting of the lyophilization systems.
• →Trains other departments on lyophilization related activities.
• →Proactively evaluates system functionality to identify and prevent possible system issues that may result in equipment downtime.
• →Identifies system malfunctions that require follow up and appropriate communication across shifts and departments to ensure proper equipment readiness.
• →Assists with process/equipment validation.
• →Ability to cross-train in other Manufacturing or Maintenance areas and train others on production-related equipment.

• High school diploma or GED required with a minimum 6 years of related manufacturing experience preferred
• Associates degree, preferably in a Science or Maintenance/Engineering field, with a minimum of 4 years related manufacturing experience.
• Knowledge of PLCs preferred
• Experience with refrigeration, compressors, condensers, HVAC preferred
• Ability to complete lyophilization and refrigeration training program
• Experience in a related technical field or discipline. Demonstrated ability to troubleshoot technical equipment issues/failures
• Ability to read and follow engineering prints and drawings preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

• Ability to stand and walk for extended periods of time
• Ability to lift up to 50 pounds
• Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)
• Must be able to perform overhead work (ie: sanitizing walls and ceilings)
• Must be able to gown qualify for Grade A/B areas and perform routine operations in clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear, respirator, and hearing protection
• Use of hands and fingers to manipulate office equipment is required

Duties may require overtime work

• 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

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.

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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