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Full-time
bachelor degree
Medical Coverage, Dental Coverage, Flexible Spending Accounts, Life Insurance, AD&D Insurance, Supplemental Life Insurance
Posted 39d ago
~40 hrs/week
Responsibilities
Responsible for the engineering execution and technical oversight of capital projects for expansion and sustainability within a pharmaceutical facility. This includes defining project strategies, managing budgets and schedules, and collaborating with cross-functional teams to ensure GMP compliance.
Requirements
Requires a BS degree in Engineering or a related technical field with experience levels ranging from entry-level to principal. Candidates must have knowledge of aseptic processing, packaging engineering, and proficiency in project management tools and technical drawings.
Full 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?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.
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:
Leads team in defining project strategies, developing goals and ensures project scope, budgets, and schedules are 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 Manager to track team deliverables for project completion, to create and maintain project schedules, to control project scope, and to review contractor/engineering firm submittals
Establish, track and communicate project risks in collaboration with project team
Participates in all collaborations with external engineering firms in feasibility assessments, concept design, basic design and detail design
Participates in technical review of all external engineering design reviews
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
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&ID 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[1]:
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.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
Related keywords
CAPEXGMPPharmaceutical ManufacturingAseptic ProcessingP&IDURSRFQCCMFELCERCommissioningLean Six SigmaPLCHMIVision SystemsBMS
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 Simtra US LLC)
Offices: 400 Interpace Pkwy, Building C, Suite 270, Parsippany, New Jersey 07054, US · 927 S Curry Pike, Bloomington, Indiana 47403, US · Kantstraße 2, Halle, Westfalen 33790, DE
Information TechnologySoftwareBiopharmaBiotechnologyMedicalAerospaceManufacturingPharmaceutical
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