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:

The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual contributor within the Validation and Qualification Department. This position oversees and executes equipment FAT, SAT, IQ, OQ, PQ activities along with validation and documentation activities. In addition, it includes contribution roles within Sterility Assurance and Cleaning Validation. This position reports to the Sr. Manager, Technical Services.

Responsibilities:

• Provide guidance, support, direction, and leadership through positive interaction with all personnel during daily operations.
• Represents CQV in internal, client, and regulatory audits as needed.
• Develops procedures and supports the facility equipment qualification and validation program.
• Conducts or coordinates performance qualification execution for new products.
• Maintain and generate accurate and complete records, reports and documentation as required for summary preparation.
• Makes process improvements and modifications to the validation program as needed.
• Initiates and drives change controls (CCM).
• Review and approve Master Batch Records, Master Specification Sheets, Line Manufacturing Records and Bill of Materials.
• Author and approve qualification and validation documents
• Attend Equipment FAT, including international travel as required.
• Leads and participates in planned maintenance activities, including HEPA certification and visual airflow testing (smoke testing).

 Requirements (Education and Experience):

• Bachelor’s degree required, preferably in a science or technical area
• Minimum of 2 years related experience required, preferably 2 years supervisory experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
• Self-directed with high initiative and ownership
• Critical thinking, creative thinking, and problem solving skills

Physical / Safety Requirements:

• Ability to meet Grade C and D gowning requirements.
• Duties will require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate equipment is required.
• Position requires standing for long hours, but may involve walking or sitting for periods of time.

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/

At Champion, we believe that the biggest growth catalyst doesn't lie outside, but within. It's not about more, but about untapping the potential from opportunity that already exists — from within your champions and yourself. As a product and a company, we're set on creating deeper partnerships with organizations and their champions so every person can do more, together.

But Champion doesn't just represent business growth. It represents individual and professional growth. Champion embodies our passion to build and cultivate an excellent company where we celebrate and advocate for what makes each team member a champion. We seek members with winning mindsets, creative and diverse thinking, and the desire to be all in.

Who We Are Looking For

As an early-stage startup, you will be part of the starting lineup — and at this level, you'll help define it.

We're looking for a seasoned Senior or Principal Engineer who brings deep technical expertise, strong architectural instincts, and the leadership presence to raise the bar across the entire engineering organization. You'll be a driving force behind our product, shaping both the technical vision and the culture of the team. We have great momentum with our initial product and a growing customer base — now we need someone who can help us scale intelligently and build for what's next.

What You'll Do

• Architect and lead the design of scalable, high-performance systems across our full stack using TypeScript, Node.js, Python, and React
• Drive technical strategy — evaluate tradeoffs, establish patterns, and make foundational decisions that will shape the platform for years to come
• Own complex, ambiguous problems end-to-end, from discovery through delivery, with minimal direction
• Design and build data infrastructure — data pipelines, warehousing solutions, and the data models that power product analytics and customer insights
• Develop and integrate ML-powered features where applicable, including model evaluation, feature engineering, and productionizing models at scale (strong plus)
• Mentor and grow engineers at all levels through code reviews, design discussions, and technical guidance
• Partner cross-functionally with Product and Design to refine roadmap items into well-scoped, high-impact work
• Leverage AI-powered developer tooling (e.g., Claude Code, GitHub Copilot) to accelerate delivery, improve code quality, and set a standard for how the team integrates these tools into everyday workflows
• Champion (pun intended) extensible, secure, and observable software patterns across the organization

What You'll Need

• 8+ years of professional software engineering experience, with a track record of leading technical initiatives on high-performing teams
• Deep proficiency in TypeScript, Node.js, React, Vu, and/or Python; strong ability to ramp quickly on new technologies as the stack evolves
• Demonstrated experience architecting and operating distributed systems, microservices, and REST APIs at scale
• Strong hands-on experience with Cloud platforms (AWS or Google Cloud), including infrastructure design and cost-conscious scaling
• Advanced SQL proficiency and experience with relational database design, query optimization, and schema evolution
• Experience with data warehousing and data pipeline development (e.g., Snowflake, BigQuery, dbt, Airflow) — strong plus
• Exposure to machine learning workflows — feature engineering, model serving, or MLOps — in a production environment (strong plus)
• Excellent communication skills with the ability to influence technical and non-technical stakeholders in a remote-first environment
• A strong testing discipline, including unit, integration, and end-to-end testing strategies

Additional Information

• $140k – $180k annual salary based on experience
• Comprehensive benefits, including healthcare, dental, and vision coverage for employees
• Meaningful equity grants
• Monthly equipment stipend to cover laptop, monitor, and any software or equipment you may need
• Hybrid or fully remote position
  • Local team members (preferred) come into the office approximately 2x per week (flexible)
  • Remote team members travel to the office approximately 2–4x per year for training, corporate events, or other business needs

Values We Live By

Go On Offense — We champion a culture of experimentation and adaptation, unafraid to maneuver as circumstances evolve, and we play to win.

Be Better Than Yesterday — In our arena of growth, every day is a new game.

Get Curious, Not Critical — We learn in a deeper, more meaningful way, driving greater impact.

Check Your Ego at the Door — We are curious, collaborative, open to feedback, and all in to do whatever it takes. The best idea wins, no matter who it comes from.

One Team, One Goal — We believe and understand that we all impact the collective goal.

Champion is an equal-opportunity employer, and we value diversity at our company. We don't discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.