Senior Process Engineer

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 Senior Process Engineer is responsible for continuous improvement on equipment and processes by providing floor support and troubleshooting as required on specific equipment associated to formulation and filling, such as lyophilizers, autoclaves, depyrogenation tunnels, terminal sterilizers, and cleaning systems. This role also ensures that equipment is operating reliably and efficiently in order to meet production and quality standards. An Engineer will and Change Control protocols. This position will be responsible for managing projects (vendor relations, procurement, installation, and functional testing) and executing required documentation (work orders, change controls, SOPs) to achieve both budget and timeline requirements. This position reports to the Manager of Process Engineering.

What you'll be doing:
• Implement improvement projects for equipment reliability, proactive maintenance, and process improvement
• Perform process reviews and prepare technical documentation detailing equipment operation and recommended changes
• Contribute to product transfer teams to meet Client timelines and expectations
• Develop and maintain project schedules using MS Project
• Perform validation maintenance reviews of equipment
• Suggest and develop energy and time saving ideas and improvements
• Evaluate and recommend products and systems in key technology areas
• Prioritize tasks to resolve complex problems and execute non-conformance investigations and associated corrective actions
• Require little direction, works on technical projects, and has sufficient knowledge within area of functional responsibility (interpret prints and drawings, procure parts and set safety stock, define critical part functionality/requirements)
• Must have positive attitude, critical thinking and clear decision-making skills
• Must be able to multi-task, prioritize projects and complete projects on-time within budget

What you'll bring:
• BS in Engineering (Chemical, Mechanical, Electrical, or a related field)
• 5+ years of experience in pharmaceutical environment
• Ability to lead and execute various engineering projects (scope, change control, vendor management, etc.)
• Experience with depyrogenation tunnel, terminal sterilizers, autoclaves, lyophilizers, and cleaning equipment
• Experience in aseptic manufacturing environment preferred
• Experience with PLC, HMI, Vision Systems and Building Management
• Computer proficiency in MS Office Suite (Word, Excel, PowerPoint Outlook)
• Experience using enterprise software (i.e., JDE, BPLM, Pilgrim, Trackwise, etc.)
• Ability to read mechanical and electrical drawings

Physical/Safety Requirements:
• Must be able to lift up to 50lbs
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting or standing for long hours
• Must be able to gown qualify for Grade A/B areas

#IND-USOPS  #LI-TL1

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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