CAPEX Project Engineer

Simtrabps; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Education Assistance Program

Employee Ownership Plan

Workout Facility

Cafeteria

Job summary

Simtra BioPharma Solutions is hiring a Project Engineer to oversee engineering execution of capital projects at our Bloomington facility. The role requires managing project delivery in compliance with Good Manufacturing Practices.

Key responsibilities include defining project strategies, managing risks, and collaborating with cross-functional teams. Ideal candidates should hold a BS in Engineering, with varying levels of experience based on the role level. Simtra offers significant benefits including medical coverage, 401(k), and wellness programs.

Qualifications

• 0-2 years of experience for Level I.
• 2-5 years of experience for Level II.
• 5-8 years of experience for Level III/Sr.
• 8-15 years of experience for Level IV/Principal.
• 15+ years of experience for Level V/Sr. Principal.

Responsibilities

• Lead team in defining project strategies and ensure project scope.
• Interact with management and stakeholders for effective communication.
• Assist in risk identification and proactive management.
• Develop project documentation and collaborate with engineering firms.

Skills

Project management

Engineering principles

Lean Six Sigma

Communication skills

Education

BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical)

Tools

Microsoft Project

JIRA

Job description

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?

We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

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

• Lead team in defining project strategies, developing goals and ensuring project scope, budgets, and schedules are defined to meet project requirements
• Continuously interact with all functions and levels of management ensuring effective, ongoing communications across teams and stakeholders
• Assist project manager to ensure identification and communication of project risks, develop risk plans and lead team in proactive management of risk response strategies
• Anticipate potential conflict situations and manage to a successful outcome
• Assist Project Manager to track team deliverables for project completion, create and maintain project schedules, control project scope, and review contractor/engineering firm submittals
• Establish, track and communicate project risks in collaboration with project team
• Participate in all collaborations with external engineering firms in feasibility assessments, concept design, basic design and detail design
• Participate in technical review of all external engineering design reviews
• Develop project URS, RFQs, CCMs, Work Orders, preventative maintenance plans, P&A redlines, spare parts management among other activities directly related to project documentation.
• Collaborate with multifunction teams to develop project Capital Expenditure Requests (CERs) and Front‑End Loading (FEL) 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&A drawings
• Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Proficient in project management tools (MS Project, Primavera, JIRA, etc.)
• Experience and the ability to use enterprise software (examples include JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)

Physical/safety requirements

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0‑10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
  • Vision Coverage
  • Accident
  • Critical Illness
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal and more
• Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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