Simtra US LLC
Technical Services Associate I (Risk Management)
Simtra US LLC, Bloomington, Indiana, United States, 47401
Overview
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 Technical Services Associate I (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.
Responsibilities
Provide guidance and technical expertise of regulatory and Baxter requirements in Risk Management strategies and processes.
Assess risk associated with non-conformances, complaints, audits, change control etc. and update the site process FMEA with new risks as needed.
Approve risk forms submitted with newly identified risk submitted via non-conformance investigations, complaints, audits, change control etc.
Author and/or approve applicable risk assessment documents for equipment and manufacturing process related changes.
Author and/or approve applicable deviation reports for product and process related deviations.
Help lead Risk Management activities for sustaining Engineering/Manufacturing projects
Provide SME input to risk remediation activities.
Support risk assessment of new processes to be validated.
Use statistical tools to analyze data.
Perform annual reviews of all process FMEAs.
Participate in regulatory inspections.
Desirable qualifications
Bachelor's degree required, preferably in a science or engineering related field
Pharmaceutical industry experience in parenteral manufacturing a plus
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, 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
Benefits 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
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.
Data Privacy To learn more about Simtra\'s approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
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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 Technical Services Associate I (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.
Responsibilities
Provide guidance and technical expertise of regulatory and Baxter requirements in Risk Management strategies and processes.
Assess risk associated with non-conformances, complaints, audits, change control etc. and update the site process FMEA with new risks as needed.
Approve risk forms submitted with newly identified risk submitted via non-conformance investigations, complaints, audits, change control etc.
Author and/or approve applicable risk assessment documents for equipment and manufacturing process related changes.
Author and/or approve applicable deviation reports for product and process related deviations.
Help lead Risk Management activities for sustaining Engineering/Manufacturing projects
Provide SME input to risk remediation activities.
Support risk assessment of new processes to be validated.
Use statistical tools to analyze data.
Perform annual reviews of all process FMEAs.
Participate in regulatory inspections.
Desirable qualifications
Bachelor's degree required, preferably in a science or engineering related field
Pharmaceutical industry experience in parenteral manufacturing a plus
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, 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
Benefits 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
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.
Data Privacy To learn more about Simtra\'s approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
#J-18808-Ljbffr