What are the responsibilities and job description for the Aseptic Process Validation Specialist position at Fagron Sterile Services US (FSS)?
This job was posted by https://www.kansasworks.com : For more
information, please see: https://www.kansasworks.com/jobs/13592631
## Who We Are
Since 1990, weve grown into a global leader in personalized medicine.
Today, our 5,000 energetic employees are based in 80 locations in
Europe, North America, South America, Africa and Asia-Pacificand are
working together to support over 200,000 customers worldwide.
From compounding and natural products to software, equipment, and
genomics we deliver smart, ready-to-use solutions that make healthcare
better.
Were passionate, science-driven, and always looking for new ways to
improve lives. ??
Explore your future at[Fagron Career
Site](https://fagron.jobsmarket.site/pages/en-gb/jobs).
## About the Job
The Aseptic Process Validation Specialist is responsible for planning,
executing, and overseeing aseptic process simulations (media fills) to
ensure compliance with regulatory requirements and internal quality
standards. The role involves coordinating cross-functional teams,
documenting processes, analyzing results, and driving continuous
improvement initiatives in aseptic operations.
**Key Responsibilities**
of Pharmacy).
**Basic Qualifications**
**Working Conditions**
Fagron offers its associates competitive salaries and a wide range of
benefits including a 401(k) plan with a company matching contribution;
medical, vision and dental; health savings account (HSA); holiday/paid
time off.
At Fagron, youll find plenty of chances to grow both personally and
professionally. We work in an open, dynamic environment where your ideas
and talents can shine.
## Ready for the challenge?
Were proud to be an equal opportunity employer. ?? Diversity makes us
stronger, and were committed to creating an inclusive workpl ce where
everyone feels welcome.\
\
Fagron US is committed to creating a diverse environment and is proud to
be an equal opportunity employer. All qualified applicants will receive
consideration for employment without regard to race; creed; color;
religion; national origin; sex; age; disability; sexual orientation;
gender identity or expression; genetic predisposition or carrier status;
veteran, marital, or citizenship status; or any other status protected
by law.
information, please see: https://www.kansasworks.com/jobs/13592631
## Who We Are
Since 1990, weve grown into a global leader in personalized medicine.
Today, our 5,000 energetic employees are based in 80 locations in
Europe, North America, South America, Africa and Asia-Pacificand are
working together to support over 200,000 customers worldwide.
From compounding and natural products to software, equipment, and
genomics we deliver smart, ready-to-use solutions that make healthcare
better.
Were passionate, science-driven, and always looking for new ways to
improve lives. ??
Explore your future at[Fagron Career
Site](https://fagron.jobsmarket.site/pages/en-gb/jobs).
## About the Job
The Aseptic Process Validation Specialist is responsible for planning,
executing, and overseeing aseptic process simulations (media fills) to
ensure compliance with regulatory requirements and internal quality
standards. The role involves coordinating cross-functional teams,
documenting processes, analyzing results, and driving continuous
improvement initiatives in aseptic operations.
**Key Responsibilities**
- Process Simulation Execution:
- Plan, schedule, and execute aseptic process simulations (media
of Pharmacy).
- Ensure the sterile environment and practices adhere to validated
- Documentation and Reporting:
- Prepare and maintain comprehensive records of media fill protocols,
- Generate and present reports summarizing APS findings, trends, and
- Compliance and Quality Assurance:
- Ensure APS activities comply with cGMP, regulatory, and company
- Act as a liaison during internal and external audits related to
- Team Coordination:
- Collaborate with production, quality, and validation teams to ensure
- Train personnel on aseptic techniques and media fill protocols.
- Continuous Improvement:
- Analyze APS outcomes to identify process gaps or improvement
- Propose and implement corrective and preventive actions (CAPA) to
- Risk Assessment and Troubleshooting:
- Perform risk assessments related to APS execution and aseptic
- Troubleshoot issues encountered during simulations and ensure timely
- Key Performance Indicators (KPIs)
- Timeliness and compliance of APS execution.
- Accuracy and completeness of APS documentation.
- Reduction in APS-related deviations and implementation of CAPA.
- Continuous improvement in aseptic process efficiency.
**Basic Qualifications**
- Strong knowledge of cGMP, FDA, and other relevant regulatory
- Excellent organizational and project management skills.
- Proficiency in data analysis and technical writing.
- Effective communication and interpersonal skills for
**Working Conditions**
- Work in cleanroom environments requiring adherence to strict gowning
- Ability to work flexible hours to accommodate media fill schedules.
Fagron offers its associates competitive salaries and a wide range of
benefits including a 401(k) plan with a company matching contribution;
medical, vision and dental; health savings account (HSA); holiday/paid
time off.
At Fagron, youll find plenty of chances to grow both personally and
professionally. We work in an open, dynamic environment where your ideas
and talents can shine.
## Ready for the challenge?
Were proud to be an equal opportunity employer. ?? Diversity makes us
stronger, and were committed to creating an inclusive workpl ce where
everyone feels welcome.\
\
Fagron US is committed to creating a diverse environment and is proud to
be an equal opportunity employer. All qualified applicants will receive
consideration for employment without regard to race; creed; color;
religion; national origin; sex; age; disability; sexual orientation;
gender identity or expression; genetic predisposition or carrier status;
veteran, marital, or citizenship status; or any other status protected
by law.