MedChem
Engineering Services LLC
is a recruiting and staffing company dedicated to helps companies recruit and manage contingent workers by providing the best talent in the industry for every client needs.
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.
Other Requirements
:
Availability to start immediately.
**CANDIDATE MUST LIVE IN PUERTO RICO*
Job Types
: Full-time, Contract
Duration:
One year plus
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