QC Micro Sr Associate

Desired Skills: environmental monitoring,cleanrooms,bioburden

The Role:

PE Global are recruiting for a SR QC Microbiology Associate to be based in Dun Laoghaire

12 Month initial contract – 24/7 Shift

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours. Example Shift Patter: Two days followed by Two nights: from 07:00 to 19:00 & 19:00 to 07:00.

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 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

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey Mccarthy on +353 21 4297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net