Engineering Manager, Biopharma Systems

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:

We are seeking a highly skilled and experienced Engineering & Technology (Biopharma Sytems) Manager to join our pharmaceutical manufacturing company. The ideal candidate will be responsible for overseeing all engineering and technology aspects of our manufacturing operations, ensuring the efficiency, safety, and compliance of our production processes.

 

The responsibilities:

• Lead and manage a team of engineers and technologists to support manufacturing operations and projects.
• Lead the engineering evaluations of manufacturing, critical utilities, facilities and plant equipment to optimize performance and ensure timely lifecycle investments in this equipment.
• Provide guidance and train maintenance and line engineers on proper care and operation of this equipment.
• Develop and implement engineering strategies to optimize manufacturing processes and improve productivity.
• Ensure compliance with regulatory requirements and industry standards related to pharmaceutical manufacturing.
• Identify opportunities for process improvement and innovation within the manufacturing environment.
• Identify, evaluate and implement improvements in energy supply, generation, usage and distribution.
• Collaborate with cross-functional teams, including Research & Development, Quality Assurance, and Operations, to align engineering and technology initiatives with overall company goals.
• Manage engineering projects from conception to completion, including budgeting, resource allocation, and timeline management.]
• Implement new technologies, controls, and automation systems to enhance manufacturing efficiency and quality.
• Conduct risk assessments and implement risk mitigation strategies for engineering projects.
• Foster a culture of continuous learning and development within the engineering team.
• Build and maintain relationships with external vendors and suppliers to source equipment, materials, and services for engineering projects.

 

Desirable qualifications:

• Bachelor’s degree in engineering or a related field; advanced degree preferred.
• 3–5 years proven experience in engineering and technology management within the pharmaceutical or manufacturing industry.
• Strong knowledge of pharmaceutical manufacturing processes, regulations, and best practices.
• Excellent leadership and team management skills.
• Demonstrated ability to drive process improvement and innovation.
• Exceptional project management and problem-solving skills.
• Effective communication and collaboration skills.
• Ability to work in a fast-paced and dynamic environment.

 

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending