Kelly Services are recruiting for a temporary Senior Microbiologist for our Dublin based pharmaceutical client. 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 & Isolators
* Reading of Environmental Monitoring Plates
* Bioburden testing of water & disinfectants
* Writing technical reports
* Water sampling
* Testing of In Process samples such as Protein Concentration, Density & pH
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
* 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
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.
