This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.
Specific Job Duties:
Environmental Monitoring of Grade 8/9 Cleanrooms
Environmental Monitoring of Grade 5/7 Cleanrooms, RABS & Isolators
Reading of Environmental Monitoring Plates
Bioburden testing of water & disinfectants
Writing technical reports such as monthly and annual EM trend reports
Water sampling
Testing of In Process samples such as pH
Testing of Biological Indicators
Basic Qualifications
* Bachelors degree in a science discipline
* Biopharmaceutical QC experience in a microbiology lab
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Preferred Qualifications
* Experience working in an aseptic cleanroom performing Environmental Monitoring
* Proficient in the use of LIMS & LMES
Competencies
* Technically strong background in microbiology and aseptic manufacturing
* Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
* Flexibility - the EM role often encounters changing priorities on a daily basis
* Problem solving skills
* Experience with Regulatory inspectors and interacting with inspectors desirable
* Demonstrated ability to work independently and deliver right first time results
* Works under minimal direction
* Work is guided by objectives of the department or assignment
* Follows procedures, GxP and DI practices.
* Refers to technical standards, principles, theories and precedents as needed
* May set project timeframes and priorities based on project objectives and ongoing assignments.
* Recognizes and escalates problems
* Demonstrated leadership and communication skills
* Auditing documentation and operation process
* Demonstrated ability to interact with regulatory agencies
