OPEX Process Specialist II

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 II 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 II 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
  
  

Required Qualifications

• 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]:

• 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 12/31/24

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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