PE Global are currently recruiting for a Sr Associate Microbiologist – Environmental Monitoring for our Bio client site in South Dublin:
12 month initial contract
This role will support qualification of a new production facility by writing qualification documents, SOPs, trend reports etc. The current expectation is to work days, however there may be a request to go on shift at a later date in order to support performance qualification of the new facility.
Specific Job Duties:
• Lead QC Technical documentation projects as an individual contributor.
• Accountable for timely completion of projects within the technical writing role.
• Collaborate with internal resources and business partners to support project requirements and ensure project completion.
• Work in accordance with cGMP and GLP requirements.
• Ensure consistent and good documentation practices are followed.
• Creation, review, and update of documentation, e.g. Laboratory Technical Protocols and Reports, Standard Operating Procedures, and Analytical Protocols.
• Translating complex topics into clear, concise, and understandable topics is required.
• Review standards for documentation types, structure, and assembly so that content is organised logically with the end reader in mind.
• Maintain Documents in the document management system.
Additional tasks:
• Support QC Specialist with risk assessments/procedures for new facility
• Working with the project team to ensure we have sufficient resources and equipment for the project
• Completing qualification works for the new isolator, media qualification etc
• Reading & review of EM plates
• Execution of EM PQ of new facility
Basic Qualifications
• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in Environmental Monitoring
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Experience in technical writing
Preferred Qualifications
• Experience working in an aseptic cleanroom
• 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
• Good cross functional communication skills are essential
• Presentation skills
• 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 on 0214297900 or alternatively send an up to date CV audrey.mccarthy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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