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 an entry-level Project Engineer I to support project management and engineering tasks within the Bloomington facility. This position is 100% onsite and reports to the Manager of Capital Projects.
The responsibilities:
- 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 schedule
- 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
Required qualifications:
- BS degree in any Engineering field
- Stong oral and written communication skills
- Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, and Teams)
- Ability to learn how to use enterprise software
- Preferred experience in working in an aseptic manufacturing plant (processing and/or packaging)
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
- Voluntary Insurance Benefits
[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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy
What We Do
As a premier, independently owned CDMO with over 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class cGMP sterile fill/finish, technical expertise, quality service, and a uniquely collaborative approach. Pharmaceutical and biotech companies partner with us when they face formulation challenges, clinical supply hurdles, surges in demand due to market fluctuations, or risk mitigation concerns. Our teams are driven to offer our clients tailored and versatile solutions to help them bring their products to market so they can get to the patients who need them.
(Simtra is a tradename of Baxter Oncology GmbH and Baxter Pharmaceutical LLC)
