Principal Project Engineer

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:

The Principal Project Engineer is a member of the Capital Expenditure (CAPEX) Engineering Organization and is responsible for leading cross-functional initiatives and project teams through the identification, justification, prioritization, initiation, development and implementation processes. The Principal Engineer will collaborate with Quality, Manufacturing, Engineering, Program Management, Technical Services, and Maintenance & Reliability departments to define project scopes and milestones to achieve commitments and identify issues and risks associated with existing facility assets or new assets. The individual is expected to have independent interactions, influence and lead the project team to ensure the accountability for deliverables and commitments and must effectively communicate with support functions, multiple levels of management and customers. This role is vital in ensuring that pharmaceutical products are packaged safely and effectively, maintaining product integrity and compliance. The Principal Engineer will report to the CAPEX Manager and is 100% onsite at the Bloomington facility.

The responsibilities:

• Leads team in defining project strategies, developing goals and ensures project scope is defined to meet requirements, primarily in the packaging areas, but can support all areas in the plant
• Oversee and manage packaging projects from conception to completion, ensuring timelines, budgets are met
• 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 managers track team deliverables for project completion
• Assists project manager to create and maintain project schedules
• Assists project manager to control project scope creep
• May be requested to support projects both from a project engineer function as well as a project manager role
• In collaboration with the team, establish, track and communicate project risks
• Leads all collaborations with external engineering firm in feasibility assessments, concept design, basic design and detail design
• Leads 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&ID redlines, 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
• Leads training site stakeholders as project is turned over to the sit
• Presents project technical scope to site stakeholders and project sponsors/endorsers
• Provides technical guidance and demonstrating thorough understanding of equipment within area of expertise in Finishing/Packaging and by supporting one or more areas of expertise: Facility/Utility, Formulation/Fill, Technical Transfer/Project Management
• Understands engineering standards used across multiple sites
• Collaborates and supports projects across sites (Bloomington, IN and Halle, Germany)
• Mentors junior project engineers
• Participates/leads project technical reviews for all projects
• Manages projects and reports project timelines, status, and costs including capital and cross-functional expenses

Required qualifications:

• BS in Engineering (Mechanical, Packaging, Electrical, Pharmaceutical, etc.), or a related field
• 10+ years experience in project engineering in a pharmaceutical (or similar) environment
• Experience working in aseptic manufacturing plant (with GMP and worldwide regulatory agency guideline experience)
• Preferred experience in a CDMO facility
• Strong communication skills (oral and written)
• Knowledge of risk management strategies
• Experience working with project management tools (i.e., Microsoft Project, or similar)
• Experience using AUTOCAD (ability to read drawings of packaging systems)
• PMP (Project Management Professional) Certification preferred
• Lean manufacturing experience required (i.e. value stream mapping, leading Kaizen events to drive positive change on the floor, and a solid understanding of DMAIC)
• Advanced proficiency in Microsoft Office Suite (Word, Power Point, MS Projects, Excel, and Outlook)
• Knowledge and experience of using enterprise software

In return, you'll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability 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
• Additional Benefits
  • 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 12/31/24

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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