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.


Your role at Simtra BioPharma Solutions:

The Process Specialist II provides technical/process support as a Subject Matter Expert for the manufacturing filling line operations with the goal of maximizing production efficiency. The position is visible on the manufacturing floor. It has high interaction with the production team to resolve issues during manufacturing. Drives improvements in overall process and equipment effectiveness (equipment availability, operator efficiency and product yield).

 

What you’ll do:

  • Develop a solid understanding of filling line manufacturing processes / equipment – evolve into SME for assigned area. Equipment focus may cover syringe, vial or cartridge line / value stream, including component washer, depyrogenation tunnel, filling and stoppering machine, capper and tray loader. Preparation and operation of Lyophilizers is in scope of this position as well
  • As SME status achieved, serve as advisor to BLT relative to assigned equipment and processes
  • Develop a solid understanding Lean/Six Sigma tools: SPC, CPk, Statistics, Pareto, Fishbone, 5-Why’s, etc. Utilize these tools to drive improvements in overall equipment effectiveness
  • Participate in cross functional continuous improvement initiatives that directly impact operations performance
  • Participate in and/or author investigation/analysis of complex issues and determine root cause(s) and implement innovative, cost effective corrective actions to prevent recurrence
  • Support team deliverables for equipment related processes
  • Review process trends to identify areas of improvements, including: equipment downtime (PM’s, spare parts, equipment/tooling design), operator efficiency (set-up, tear-down, overall batch run speed) and product yield issues
  • Responsible for standardization/training of set-up and basic troubleshooting procedures for Production Leadership and SME identified Operators
  • Key member of the filling line Total Productive Maintenance (TPM) team
  • Ability to create, manage and approve Master Change Control, Equivalency Forms and Work Orders
  • Coach/mentor and train Maintenance Technicians and Production Operators
  • Act independently with minimal supervision
  • Maintain Grade A/B aseptic gowning certification; successful operator qualification/media fill performance

 

What you’ll bring:

  • Bachelor’s Degree with a background in aseptic operations or >10 years related experience
  • Understanding of Good Manufacturing Practices
  • Computer proficiency in Word, Excel, and Outlook and the ability to use enterprise software, such as BPLM, Maximo, Trackwise, etc.
  • Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems
  • Six Sigma Green Belt or Black Belt certification preferred; expectation will be to obtain at minimum a Green Belt certification.

 

Physical / Safety Requirements:

  • Must be able to lift up to 50 lbs
  • Duties may require overtime work, including nights and weekends
  • Extended periods of standing and/or walking
  • Extended periods in Grade A, B, C, D production environments
  • Use of hands and fingers to manipulate equipment is required

 

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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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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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