For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The Lead Machinist works as a key member of a high-performance team responsible for supporting daily manufacturing operations and equipment in a pharmaceutical production environment. Additionally, the Lead Machinist consults with production/engineering and distributes project work to staff and ensures the work is completed in a timely manner. This position reports to the Machine Shop Manager.

What you'll be doing:

• Oversees Machine Shop personnel
• Consults with other departments regarding future projects, work orders, etc.
• Determines feasibility and priority of work to be performed
• Determines materials needed for new work/projects
• Maintenance consistent safety and excellence, including project & cost tracking, consumables & material stocking, and equipment maintenance
• Repair of manufacturing equipment and tooling
• Responsible for set up and operation of CNC machine tools (lathes, milling machine, saw, grinder)
• Verifies machined parts conformance to specifications
• Reverse engineer and measure parts using CMM equipment
• Maintain appropriate equipment documentation and change control according to company procedures
• Participate in spare analysis and inventory development

What you'll bring:

• 10 years' experience as an Equipment or Tool & Die Machinist
• 2 years' supervisory experience
• 2-year degree (tooling or machining discipline, preferred)
• Experience in programming and operating CMM equipment
• Experience programming and operating CNC machines (including lathes and mills)
• Microsoft Office Suite (Word, Excel, and Outlook) intermediate to advanced proficiency
• Ability to read and understand blueprints
• Strong attention to detail and the ability to work with precision
• Ability to use basic math skills for calculations and measurements
• Ability to weld, machine to repair various material, within tolerance of existing parts
• Ability to complete Aseptic 10K Gowning Certification

Physical/Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 lbs
• Must be required to stand for over 4 hours per day
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required
• Use of hands and fingers to manipulate office equipment and hand tools, as required
• Duties may require overtime work, including nights and weekends

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Equal Employment Opportunity

Simtra is 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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Pay Transparency Policy

Reasonable Accommodations

Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Data Privacy

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