OPEX Process Specialist

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 OPEX (Operational Execution) Process Specialist provides technical/process support to maximize production efficiency. The position is visible on the manufacturing floor and has high interaction with the production team. It’s expected that the OPEX Process Specialist will drive process improvements and equipment effectiveness (equipment availability, operator efficiency and product yield). This position reports directly to the Associate Director of OPEX and indirectly to production management. This position is 100% onsite at the Bloomington location.

The responsibilities:

Evolve into a SME (subject matter expert) for assigned manufacturing processes/equipment - including, but not limited to, syringe/vial lines (value stream), lyophilizers, isolators, and packaging equipment

Serve as advisor to building leadership, relative to assigned equipment and processes

Use Lean/Six Sigma tools (SPC, CPk, Statistics, Pareto, Fishbone, 5-Why’s, etc.) to drive improvements in overall equipment effectiveness (OEE)

Participate and lead cross-functional continuous improvement initiatives (Kaizens) impacting performance and conversion loss

Manage multiple projects and work with cross-functional teams

Responsible for standardization/training of set-up, operating, and troubleshooting procedures for production, maintenance, and training personnel

Ability to create, manage and approve master change controls and work orders

Participate in and/or author investigation/analysis of complex issues and determine root cause(s) and implement innovative, cost-effective corrective actions to prevent recurrence

BS degree in science or technology preferred or 5+ years of pharmaceutical manufacturing experience in lieu of a BS degree

3+ years experience in a regulated industry/environment

Intermediate proficiency in Microsoft Office Suite (Word, Excel, and Outlook)

Excellent problem-solving skills with ability to provide solutions

Excellent oral and written communication skills

Six Sigma Green Belt certification or higher preferred

Physical / safety requirements:

Duties may require overtime work, including nights and weekends

Extended periods of standing and/or walking

Extended periods in Grade C/D production environments

In return, you’ll be eligible for [1] :

401(k) Retirement Savings Plan with Company Match

Paid Parental Leave and more

Accident

Legal and more

Cafeteria

[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.

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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