Scientist- Sterility Assurance
- Employer
- Discovery Solutions, Inc.
- Location
- Indianapolis, IN
- Start date
- Oct 4, 2022
View more
- Discipline
- Manufacturing & Production, Facilities & Site, Materials/Inventory Control, Safety, Science/R&D, Biology, Microbiology
- Required Education
- Bachelors Degree
- Position Type
- Full time
COMPANY:
Discovery Solutions is seeking job seekers for a full time opportunity with one of our pharmaceutical industry clients.
LOCATION:
- Indianapolis, IN with remote options
- Office space available at location listed and typically 1 day a week work from home
- This position will be in Indianapolis, but will require 5-10% travel
- Applicant will work in various areas within the Parenteral Site. Some allergens are present.
- Applicant will be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities. Mobility requirements should be considered when applying for this position
SHIFT:
- 8-hour days – Monday through Friday
- Overtime may be required
- On call rotation (by phone) may be required
DESCRIPTION:
JOB SUMMARY:
The Scientist positions in the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS / MS – SAT) group are positions that provide support for control of the sites manufacturing facilities. Are you looking to make an impact on a deep technical level to the way we manufacture medicine safely and efficiently? Our group develops and implements sterility assurance related initiatives and provides technical leadership to the site!
RESPONSIBILITIES:
- Ensure site’s Environmental Monitoring, Aseptic Process Simulations, Facility Cleaning, Facility Sanitization, Sterility Assurance Risk Management, and other sterility assurance programs are followed at the manufacturing line level.
- Provide technical mentorship to the Flow and Process Teams for sterility assurance programs.
- Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
- Lead or provide technical support for root cause investigations.
- Use of sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the possibility for introduction of microbial, endotoxin and particulate contamination.
- Complete and assist in the development of process and facility monitoring strategies that focus on areas of the highest microbial risk.
- Lead site aseptic self-inspection program including communication of observations and recommendations for improvements to manufacturing and support personnel.
- Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for improvements.
- Build, implement, review and/or approve technical documents and change controls related to sterility assurance programs including risk assessments, justification documents, aseptic process simulation protocols, and summary reports.
- Engage in or provide guidance during regulatory audits. Provide content and/or data integrity reviews for regulatory submissions.
COVID VACCINATION:
- Vaccination against COVID-19 is a requirement of the position
EDUCATION & EXPERIENCE
Basic Requirements:
- Bachelor's Degree in STEM field (microbiology or biology preferred)
- 3 years of experience in a regulated environment (aseptic processing and/or sterility assurance experience preferred)
Additional Preferences:
- Understanding of GMPs and applicable internal standards
- Parenteral Manufacturing or product protection control strategy experience
- Experience with data trending and analysis
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