Sterilization Specialist

MedChem
Engineering Services LLC
is an agency specialized to provides a complete range of professional services to pharmaceutical and medical devices clients.
MedChem
operates in Puerto Rico. For more information, please visit our website: www.medchemengineeringservices.com
MINIMUM QUALIFICATIONS
Education and/or experience:
BS in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Microbiologist, Chemist, Biology or related field.
Hands-on experience generating and executing
Sterilization Qualification
protocols and including Final Reports.
Minimum of 3-5 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least three (3) years experience with ETO Sterilization Qualification
Responsibilities
Ensure Sterilization processes comply with international and domestic requirements.
Provide guidance for bioburden monitoring, environmental monitoring, and environmental control room practices.
Evaluate the impact of new or modified manufacturing processes on existing sterilization methods and validations.
Ability to present findings as required to a variety of levels throughout the organization.
Prepare comprehensive summaries, discussion of scientific data, reports of current state of the data related to sterilization and sterility assurance process.
Performs gap assessment on sterilizatio process.
Compile reports to ensure the appropriate regulatory requirements are met and sterility assurance levels are maintained.
Prepare test strategy as needed for validations, engineering studies, stability studies, new product introduction, etc.
**CANDIDATE MUST LIVE IN PUERTO RICO**
Job Types: Full-time, Contract
Pay: $80,000.00 - $95,000.00 per year
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
Work Location: In person