Project Associate II

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 looking for a Project Associate II, responsible for overseeing and maintaining Capital expenditure (Sustaining), including forecasting and adherence to financial policies. Additionally, this role will lead small CAPEX projects and ensure they 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 finance, manufacturing, quality, EHS, maintenance, validation, and procurement to ensure successful project delivery. This position is 100% onsite at the Bloomington, Indiana facility.

 

 

The responsibilities:

• ~50% of time spent overseeing and maintaining Sustaining Capital expenditure, including forecasting and adherence to financial policies
• ~50% of time spent managing CAPEX projects, including setting scope, budget, and schedule are defined to meet project requirements and tracking deliverables for on-time project completion
• Continuously interacts with all functions and levels of management to forecast and report Capital expenditure and communicate consistently across teams and stakeholders
• 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
• Tracks team deliverables for project completion, to create and maintain project schedules, to control project scope, and to review contractor/engineering firm submittals
• Participates in all collaborations with external engineering firms in feasibility assessments, concept design, basic design and detail design. Anticipates potential conflict situations and manages to a successful outcome
• Facilitates internal and external project reviews and assessments
• Amends and updates governing procedures and supports updates
• Supports routing and approval of Engineering documentation.
• Closes Capital projects and turns in assets to finance counterparts
• Presents project technical scope to site stakeholders and project sponsors/endorsers

 

 

Required qualifications:

• BS degree or relevant experience
• 2+ years of experience required
• 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 im