Process Engineer

Simtra Bio Pharma 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  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.

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 looking for Project Engineers (level depends on experience) that will be responsible for developing, executing, and managing engineering projects related to processing/packaging. This engineer will work closely with cross-functional internal and external stakeholders. This position is 100% onsite at the Bloomington, Indiana facility.

The responsibilities:

• Depending on level, will participate in or leads team in defining project strategies, developing goals and ensures project scope is defined to meet project requirements
• Continuously interacts with all functions and levels of management ensuring effective, ongoing communications across teams and stakeholders
• Assists other project manager to ensures identification and communication of projects risks, development of risk plan and leads team in the proactive management of risk response strategies
• Anticipates potential conflict situations and manages to a successful outcome
• Assists project managers to track team deliverables for project completion
• Assists project manager to create and maintain project schedule
• Assists project manager to control project scope creep
• In collaboration with the team, establish, track and communicate project risks
• Participates in all collaborations with external engineering firm in feasibility assessments, concept design, basic design and detail design
• Participates in technical review of all external engineering design reviews
• Assists project manager in reviewing contractor/engineering firm submittals
• Develop project URS, RFQs, CCMs, Work Orders, preventative maintenance plans, P&, spare parts management among other activities directly related to project documentation
• Collaborates with multifunction teams to develop project Capital Expenditure Requests (CERs) and Front-End Loading (FEL) documents among other documents required to obtain project approvals.
  • Assists with project IQOQ & PQ activities
• Participates in training site stakeholders as project is turned over to thesite
• Presents project technical scope to site stakeholders and project sponsors/endorsers
• Participates/leads project technical reviews for assigned projects

Required qualifications:

• BS degree in any Engineering field
  • 0-2 years of experience (Level I)
  • 2-5 years of experience (Level II)
  • 5-8 years of experience (Level III/Sr.)
  • 8-15 years of experience (Level IV/Principal)
  • 15+ years of experience (Level 5 / Sr. Principal)
• Stong oral and written communication skills
• Advanced proficiency in Microsoft Office Suite (Word,…