Process Validation Associate 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:

This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Sr. Manager, Technical Services, and is 100% onsite at the Bloomington, Indiana facility.

The responsibilities:

• Supports the process validation program.
• Develops and writes process validation procedures.
• Monitors regulatory and industry validation practices to assess our compliance.
• Interacts with the client and client team to define process validation scope.
• Designs and executes the appropriate development Technical Studies to define process parameters.
• Uses statistical tools to design and analyze technical study data.
• Creates a risk assessment of the process to be validated.
• Creates process validation protocols.
• Conducts or coordinates process validation execution for new and existing products.
• Prepares validation summaries.
• Uses statistical tools to analyze process validation data.
• Performs annual reviews / continued process verification (CPV) of validation projects.
• Investigates and executes validation related Corrective and Preventive Actions.
• NCR investigation owner for process validation related, as needed
• Creates and maintains visual controls for Process Validation group
• Serves as Subject Matter Expert (SME) for process validation.
• Independently Participates in regulatory, client and internal audits and a product/process Subject Matter Expert (SME)Develop Industry knowledge, project proficiency, and be able to work independently
• Must be able to identify opportunities for optimization of processes within the department
• Proficiently uses statistical tools to design and analyze technical study data.

Desirable qualifications:

• Bachelor’s degree required, preferably in a science or engineering-related field.
• Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.).
• Ability to communicate effectively at all levels.
• Sound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.

Physical / Safety Requirements:

• May require overtime work, including nights and weekends
• Sitting for long hours and walking/standing for long periods of time
• Must be able to gown for Grade C area

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 12/31/25

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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