Project Manager - Global Serialization

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 Project Manager – Global Serialization is responsible for supporting Simtra’s Level 4 serialization solution, Tracelink, and related systems and processes as a member of the Serialization Center of Excellence (COE). The individual will be responsible for supporting and maintaining the system, managing and testing connections to existing and new clients, ensuring data integrity, troubleshooting system and IT issues related to serialization technology, and collaborating with cross-functional teams to maintain compliance with industry and company regulations. This position will report to the Sr. Manager – Packaging Materials & Global Network Lead Serialization and is 100% remote.

 

The responsibilities:

• Ensure accurate traceability of serialization data, maintaining compliance with regulations, and ensuring that all required information is accurately transferred
• Establish, test, and maintain connections of Tracelink system to new and existing customers
• Evaluate, qualify, and test new releases of Tracelinkand coordinate validation efforts with the computer system validation team
• Manage changes to systems, interfaces, and integrations
• Support customer interfaces and identify transfer issues, as applicable
• Support and collaborate with internal and external stakeholders to integrate and optimize serialization software systems
• Manage the tracing of packaging data to ensure accuracy throughout the process
• Coordinate validation efforts with the computer system validation team
• Support inspections, audits, and potential counterfeit investigations

 

Required qualifications:

• BS degree in Engineering, Computer Science, or a related field
• 8+ years experience in pharmaceutical serialization and packaging with a proven track record of working in IT support function
• Proficient in software coding related to packaging systems and serialization
• Experience with Tracelink software, or a similar system
• Experience with rfXcel RTS (traceability system)
• Experience in design documentation (URS/DS), IQ, OQ, PQ protocols, development and execution, deviations, and generation of reports
• Excellent technical writing skills
• Strong problem-solving skills and attention to detail,
• Experience with providing excellent customer focus, including interaction and communication
• Ability to work collaboratively in a fast-paced environment and to adapt to changing priorities

 

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
    • Spouse Life Insurance
    • Child Life Insurance