Lyophilization Technician (Weekend AM Shift)

Simtra BioPharma Solutions

Bloomington, IN

*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 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.

**The responsibilities:**

• 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.

**Desirable qualifications:**

• 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.)

**Physical / safety requirements:**

• 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

**Additional requirement(s):**

Duties may require overtime work

**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

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