For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The CAPEX Project Engineer III 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 Senior Project Engineer will collaborate with Quality, Manufacturing, Engineering, Program Management, Technical Services etc. to define project scopes and milestones to achieve commitments and identify issues and risks associated with existing facility assets or new assets. The Project Engineer III 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. The Project Engineer III will report to the CAPEX Manager.

What you'll be doing:

• Leads team in defining project strategies, developing goals and ensures project scope is defined to meet 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 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 site
• Presents project technical scope to site stakeholders and project sponsors/endorsers
• Provides technical guidance and demonstrating thorough understanding of equipment within one or more areas of expertise: Facility/Utility, Formulation/Fill, Finishing/Packaging
• 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 (>$1M) and reports project timelines, status, and costs including capital and cross-functional expenses.

What you'll bring:

• Bachelor degree in Engineering required
• 5+ years experience in pharmaceutical engineering and/or project management experience
• Prior experience working in aseptic manufacturing plant
• Strong verbal and writing skills
• Knowledge of risk management strategies
• Must have a working knowledge of project management tools and possess knowledge of related disciplines
• Must have knowledge of GMPs and worldwide regulatory agency guidelines
• PMP (Project Management Professional) Certification is 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)
• Computer proficiency in Microsoft Word, Power Point, MS Projects, Excel, and Outlook and the ability to use enterprise software

Physical/Safety Requirements:

• Ability to stand or sit for extended periods of time
• Duties may require overtime work, including nights and weekends
• Must be able to gown qualify for Grade A/B areas

#IND-USOPS

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Simtra is 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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