CAPEX Project Engineer

Capex Project 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.

The Role:

We are looking for a Project Engineer (level depends on experience) that is responsible for the engineering execution and technical oversight of capital projects (expansion and sustainability) within the pharmaceutical manufacturing facility. This role ensures that all projects are delivered safely, on time, within budget, and in compliance with Good Manufacturing Practices (GMP) regulatory requirements and company standards. The position works closely with cross-functional teams including manufacturing, quality, EHSS, maintenance, validation, and procurement to ensure successful project delivery.

This position is 100% onsite at the Bloomington, Indiana facility.

What You'll Do:

• Leads team in defining project strategies, developing goals and ensures project scope, budgets, and schedules are defined to meet project requirements
• Continuously interacts with all functions and levels of management ensuring effective, ongoing communications across teams and stakeholders
• Assists 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 Manager to track team deliverables for project completion, to create and maintain project schedules, to control project scope, and to review contractor/engineering firm submittals
• Establish, track and communicate project risks in collaboration with project team
• Participates in all collaborations with external engineering firms in feasibility assessments, concept design, basic design and detail design
• Participates in technical review of all external engineering design reviews
• 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

What You'll Bring (Requirements):

• BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical 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 V/Sr. Principal)
• Experience with capital project execution, from concept to commissioning
• Knowledge of the basic principles in aseptic processing and/or inspection & packaging engineering best practices
• Must be able to lead and execute engineering projects and lead multiple projects simultaneously
• Strong understanding of inspection and packaging materials, processing, and testing methods
• Experience and/or knowledge of PLC, HMI, Vision Systems and Building Management Systems
• Strong oral and written communication skills
• Lean Six Sigma or continuous improvement experience
• Must be able to read mechanical, electrical, and P&
• Advanced proficiency in…