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 a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.

The responsibilities:

• Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas
• Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes
• Develop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment
• Author and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems
• Collaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design
• Develop and maintain project schedules using MS Project
• Collaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met
• Provide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment
• Interact with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders
• Support with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence

Required qualifications:

• BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field
• 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)
• 0-2 years of experience (Level I)
• 2-5 years of experience (Level II)
• 5-8 years of experience (Level III/Sr.)
• 8+ years of experience (Level IV/Principal)
• Knowledge of the basic principles in aseptic processing and/or packaging engineering best practices
• Must be able to lead and execute engineering projects
• Strong understanding of packaging materials, processing, and testing methods
• Experience with PLC, HMI, Vision Systems and Building Management systems
• Strong oral and written communication skills
• Must be able to read mechanical, electrical, and P&ID drawings
• AutoCAD or equivalent component design knowledge
• Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• 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/

What’s in it for you?

Opportunity To Unlock Your Creativity
Think of all the times you were held back from trying new ideas because you were boxed in by bureaucratic legacy processes or old school tactics. Having a growth mindset is deeply ingrained into our company culture since day 1 so Fictiv is an environment where you have the creative liberty and support of the team to try big bold ideas to achieve our sales and customer goals.

Opportunity To Grow Your Career
Fictiv, you'll be surrounded by supportive teammates who will push you to be your best through their curiosity and passion.

Impact In This Role

Your role as a Manufacturing Engineer will be to support and drive improvement to our critical manufacturing functions. We have two sets of customers—our builders, who order parts through us, and our manufacturing partners, who manufacture and assemble these parts—and you’ll be consistently working at the interface between the two.  At Fictiv, we believe in creating the world’s premier platform for hardware manufacturing, and you’ll be playing a critical role in making that happen.

In your role as the Manufacturing Engineer, you will be reviewing and analyzing the manufacturability and costs associated with CNC machining submitted by our builders. In this role, you’ll also be using your Mechanical Engineering background and knowledge of manufacturing processes in order to determine what design changes may need to be made to our builders’ design specifications in order to meet their needs. By developing highly competitive proposals and quotations that meet the requirements called out by our customers, you will be assisting in bringing products to market faster in a wide range of industries (and helping to accelerate Fictiv’s growth)

You will report to the Costing and DFM lead.

What You’ll Be Doing

1. Package review - Study the package provided by Sales to determine scope of work, manufacturing feasibility & Lead time details
2. Should be able to define best suited manufacturing process, machine selection, cycle time calculations & setup costs
3. Should be able to generate Should cost using in house calculators & Fictiv's software recommendations
4. Manufacturing Partners quote scrutiny. To check whether the provided quote is correct in terms of optimized raw material, machining & secondary processes costs
5. Should be able to negotiate with Manufacturing partners on quotes provided and get the best costs out to ensure a win win situation
6. Should be able to understand secondary process eg Anodising, Zinc plating, Chemical conversion coatings with respect to their type, class, service class, methods etc 
7. Preparing RFQ package to Manufacturing Partners referring to capability & capacity plans 
8. Calculator Generations - Use own machining expertise & understanding of process cost drivers to develop cost calculators
9. DFx Feedback - Should be able to study the 3D Model, 2D prints to determine the manufacturability of the part & highlight key points that involve a design change recommendation
10. Automation Feedback - Provide feedback to Quoting SOftware team to improve accuracy of automated quoting of our manufacturing services
11. Packaging costs - Should be able to develop packaging concept & provide the same to Logistics team for generating Shipping costs
12. Follow up with Sales for Quoted RFQ's feedback on weekly basis & also provide feedback to Manufacturing partners about quoted RFQ's status
13. Work with CFT in evaluating value deals for project management validation, project de risking, quality documentation
14. Should be able to handle Assembly product structure
15. Help clear technical queries during MP Quoting
16. Maintaining reports  for Opportunities quoted won/lost, conversion ratio etc
17. Participate in Manufacturing Partners QBR with CFT to address cost issues, conversion ratios etc

Desired Traits

1. 6-8 years of relevant work experience
2. Meticulous, detail oriented, inclination for documentation
3. Excellent verbal and written communication skills in English required
4. Self-starter, manages time efficiently, able to complete work in a timely manner without active supervision
5. Enjoys sharing knowledge and teaching others about manufacturing processes
6. 4-year Mechanical Engineering degree 
7. 3D model & 2D print review with good proofreading capabilities
8.  5, 4, 3 Axis Milling, Turn Milling,  Grinding, Gear hobbing, Spark & wire EDM, Gun Drilling processes
9. Strong GD & T background
10. CNC machines specifications/technical data
11. CNC programming for milling & turning
12. Turning & Rotating tools selection , grades of inserts for turning & Milling, Insert specification
13. Work holding devices for CNC Turning & Milling centers
14. Recommended cutting conditions for work materials classified by ISO
15. Materials (Chemical compositions, Mechanical & Thermal properties) : Stainless steel, carbon steel, alloy steel, aluminum alloys, Tool steel Titanium plastics and their associated ASTM, ISO, IS, DIN &  MIL standards.
16. Heat treatment : Normalizing, Tempering, Annealing, Case hardening, & Quenching
17. Secondary processes : Anodising, chemical conversion coatings, Zinc plating, Nickel plating, tin plating, Bead blasting & their associated standards eg MIL , ASTM , ISO 
18. Secondary processes : Painting & Powder coating
19. Inspection instruments & methods to help improve DFM feedback
20. PPAP documentation
21. ISO 9001 : 2015 Documentation
22. AS9100D documentation
23. Proficient written & oral communication skills
24. Excel & Google sheet expertise
25. Undergone training on cutting tools through Sandvik, Kennametal etc
26. Production costing background
27. Packaging estimation : concept to development

Interested in learning more?  We look forward to hearing from you soon.

Responsibilities:

Entry level CQV Engineer position in the Pharma industry. Client will train the resource on Deviation Investigation.

Requirements

• Deviation investigation remediation experience is a plus but is not necessary.
• Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.).
• 0-3 years experience. Some Pharma experience preferred but not absolutely required. New college grads with internship experience encouraged to apply
• Proficiency using PC and Microsoft Office tools.
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
• Ability to work as part of a team.
• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.
• Strong attention to detail
• Strong interpersonal skills and clear communication capabilities.
• Experience with and tolerance for high levels of challenge and change.