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.
Your role at Simtra BioPharma Solutions:
The CAPEX Project Engineer I 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 Project Engineer I 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 I 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 I will report to the CAPEX Manager.
What you'll do:
- Leads team in defining project strategies, developing goals and ensures project scope is 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 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 from a project engineer function
- In collaboration with the team, establish, track and communicate project risks
- Participates in all collaborations with external engineering firm in feasibility assessments, concept design, basic design and detail design
- Participates in 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
- Participates in training site stakeholders as project is turned over to the site]Presents project technical scope to site stakeholders and project sponsors/endorsers
- Participates/leads project technical reviews for assigned projects
What you'll bring:
- BS in Engineering required
- Stong verbal and writing skills
- Computer proficiency in Microsoft Word, PowerPoint, MS Projects, Excel, and Outlook and the ability to use enterprise software
- Preferred experience in working in an aseptic manufacturing plant
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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Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.