Site Microbiologist

Team Horizon is seeking a Senior Micro for our client based in Sligo. This person will provide an effective microbiological and analytical service to the sterile biologics facility ensuring that Microbiological procedures and requirements are met. You will join a growing site that is a state-of-the-art Biologics Sterile Fill-Finish liquid and lyophilized product in a vial format.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  
  
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  
  
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
  
  What you will be doing:
  
  
• Implement the facilities sterility assurance program and microbiological support activities (facility design, filling of sterile product and aseptic practices)
  
  
• Lead and implement microbiological and analytical services to meet and maintain all requirements for aseptic processing, facility design and filling of sterile product
  
  
• Overview of the EM and utilities program process, aseptic progamme and contamination control strategy in a multiproduct facility. - Provide microbiological/sterility assurance/technical governance of in process and finish product per product requirements
  
  
• Understand Regulations and business processes required to maintain Abbvie’s and cGMP requirements for sterile product, inclusive of facility design, cross contamination controls, microbiological Laboratory standards and Data Integrity
  
  
• Define and update procedures for site relative to microbiological and environmental monitoring. Interface with regulatory and corporate inspectors/auditors
  
  
• Carry out training as per training plan to support facility sterility assurance program.
  
  
• Adheres to and supports all EHS & E standards, procedures and policies. EHS Responsibilities:
  
  
• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities;
  
  
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers;
  
  
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve;
  
  
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on eAchieve;
  
  
• Attend all required EHS training and medical surveillance programs;
  
  What you need to apply:
  
  
• Bachelor Degree qualification in biology or microbiology.
  
  
• A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines.
  
  
• 3 -5 years’ (minimum) experience in microbiology is a requirement & working in a sterile/aseptic/pharma environment is a distinct advantage.
  
  
• Experience in supporting regulatory inspections HPRA, FDA etc is an advantage
  
  
• Experience in cleaning validation is an advantage