Sr. Process Engineer
Simtra BioPharma Solutions · Bloomington, IN
- Level
- Senior
- Team
- Process
- Travel
- 10%
- Degree
- Required
- Experience asked
- 1+ years
- Industry
- Pharma & life sciences
- Posted
- 30+ days ago
The role in 30 seconds
A senior process role at Simtra BioPharma Solutions (pharma & life sciences) in Bloomington, IN. Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas.
- They ask for
- 1+ years · degree required
- Tools it names
- CAPA, Validation (IQ/OQ/PQ), PLC, AutoCAD
- Day to day
- some off-shift / weekend coverage · about 10% travel
Read from the posting. The full description is below.
How this role compares
Against 24 other live process postings in Indiana.
- Base pay
- Not listed in this posting
- Experience asked
- Less than usual (1+ vs 5+)
Typical $84k–$110k, from 5 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Lean 44%
- Team leadership 36%
- Six Sigma 32%
- Root cause 32%
- DOE 24%
- ✓ Validation (IQ/OQ/PQ) 24%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for AutoCAD, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Process team at Simtra BioPharma Solutions
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Is the work mostly new product launches or sustaining existing lines?
- How much time do you spend on the floor versus at a desk?
- How does off-shift and weekend coverage work?
- The posting says about 10% travel. Between which sites?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Simtra BioPharma Solutions in Bloomington
15 other open roles at this site.
- Quality Supervisor - Filling (weekend AM) · Quality · Supervisor
- Pharmaceutical Manufacturing Manager, 3rd Shift · Manufacturing · Manager
- Director, Operational Excellence · Lean / CI · Director+
- Manufacturing Supervisor, Weekend AM · Manufacturing · Supervisor
- Quality Technician - Environmental Monitoring · Quality · Technician
- OPEX Process Specialist · Lean / CI · Specialist
Full description from Simtra BioPharma SolutionsAs posted on their careers site.ShowHide
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
Show full description ↓Show less ↑
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 Sr. 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
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
- •Communi