Aseptic Manufacturing Risk Management Associate II

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Plan

Paid Holidays

Paid Time Off

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Technical Services Associate II (Risk Management) to lead risk assessment and change control activities at the site. You will interact with clients, regulatory agencies and cross-functional teams to ensure timely approval of documents. This role reports to the Technical Services Validation Sr.

Manager. You will guide regulatory compliance, assess risks, author risk assessments for equipment and process changes, and support ongoing CAPA

Qualifications

• Bachelor’s degree in science or engineering required.
• Minimum of 2 years pharmaceutical parenteral manufacturing experience.
• CQE/CMQ/OE or Six Sigma certification a plus.
• Proficiency with Microsoft Word, Excel, Outlook and enterprise software.

Responsibilities

• Provide guidance on regulatory requirements and risk management processes.
• Assess risks for non-conformances, complaints, audits, and change controls; update FMEAs.
• Review and approve risk assessments for equipment, processes, and facility changes.
• Lead risk management activities for engineering, manufacturing and process improvement projects.
• Serve as site SME for risk management and remediation guidance.
• Support risk assessments for new processes and validation projects.
• Utilize statistical tools to analyze risk and process data.
• Perform annual site FMEA reviews and CAPA/Change Control management.

Skills

Parenteral manufacturing

Quality management

Regulatory knowledge

Risk assessment

Education

Bachelor’s degree in science/engineering

Tools

JDE

Pilgrim

Veeva

Trackwise

Job description

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?

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.

The role

The Technical Services Associate II (Risk Management) is responsible for risk management activities associated with non‑conformances, complaints, equipment validation, qualification and change control activities at the BPS site. This position interacts with clients, regulatory agencies, and cross‑functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely approval of all associated documents. This position reports to the Technical Services Validation Sr. Manager.

The responsibilities

• Provide guidance and technical expertise on regulatory requirements and company risk management processes.
• Assess risks associated with non‑conformances, complaints, audits, and change controls, and update process FMEAs as needed.
• Review and approve risk assessments submitted through investigations, complaints, audits, change controls, and other quality system activities.
• Author and approve risk assessments related to equipment, manufacturing process changes, facility modifications, and construction projects.
• Author and approve deviation reports related to product and process issues.
• Lead and support risk management activities for engineering, manufacturing, and process improvement projects.
• Serve as the site Subject Matter Expert (SME) for risk management and provide guidance for risk remediation activities.
• Support risk assessments for new processes and validation projects.
• Utilize statistical tools to evaluate and analyze risk and process data.
• Perform annual reviews and updates of site process FMEAs to ensure continued effectiveness.
• Initiate, lead, and manage CAPAs and Change Control activities.
• Participate in regulatory inspections, audits, and compliance‑related inquiries.
• Contribute to the development, maintenance, and continuous improvement of risk management procedures and practices.

Required qualifications

• Bachelor’s degree required, preferably in a science or engineering related field.
• Minimum of 2 years pharmaceutical industry experience in parenteral manufacturing.
• American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification a plus.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Pilgrim, Veeva, Trackwise, etc.).

Physical / Safety Requirements

• Must be able to wear appropriate personal protective equipment.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position requires sitting for long hours but may involve walking or standing for periods of time.
• Must be able to gown for Grade C area.

In return, you’ll be eligible for

• 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

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.

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