Project Engineer, Multiple Openings

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 Project Engineers (level depends on experience) that are 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 positions work 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.

Theresponsibilities:

• 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
  required to obtain project approvals.
• Assists with project CQV (commissioning qualification and validation) 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 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 youll 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 12/31/25

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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