Risk Management 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:

The Risk Management Associate II is responsible for risk management activities associated with non-conformances, complaints, equipment validation, qualification and change control activities at the BPS site in the Technical Services department. 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 Sr. Technical Services Manager, and it is onsite 100% of the time.

The responsibilities:

• Provide guidance and technical expertise of company and industry regulatory requirements in risk management strategies and processes
• Assess current risks associated with non-conformances, deviations, change control, complaints, audits, change control etc. and update the site process FMEA with new risks, as applicable
• Approve forms that include newly identified risks submitted from non-conformance investigations, complaints, audits, change control, deviation, etc.
• Author and/or approve risk assessment documentation for following: equipment and manufacturing process related changes, facility modifications and construction projects, reports for product and process related deviations
• Assist leading risk management activities for sustaining engineering and manufacturing projects
• Be the subject matter expert (SME) and key participant in compliance audits, inquiries, and SOPs and provide SME input to risk remediation activities
• Support risk assessment of new validation processes
• Uses statistical tools to analyze data
• Perform annual reviews of all site FMEAs and process PFMEAs, identify risks, and provide mitigation (including working with cross-functional team
• Participate in regulatory inspections

The work environment:

• Onsite every day of the week

Qualifications:

• BS degree in engineering and/or science field (5 years relevant experience in lieu of BS degree)
• 2+ years pharmaceutical industry experience in parenteral manufacturing
• Quality certification from American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification preferred
• Experience using statistical tools (i.e., Minitab, Tableau, etc.)
• MS Office Suite (Word, Excel, Outlook) with advanced proficiency
• Experience using some Enterprise software (JDE, Documentum, Trackwise, etc.)
• Oral and written communication skill
• High attention to detail
  · Ability to work in a group setting

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

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.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy