Aseptic Process Owner Lead - Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location: Site BasedPay: €55 - €65 per hourExperience: 10+ years Visa: EU passport or Stamp 4 visa requiredAseptic Process Owner Lead - Dun Laoghaire, DublinOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.An exciting and rare opportunity has presented for an Aseptic Process Owner Lead.
This is a senior role in the organisation and requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.The Site Aseptic Process Owner Lead will continue to build on the site and network aseptic processing knowledge and represent the Dublin site at a global level across the manufacturing network.As the Site Aseptic Process Lead you will be an established professional who is a self-starter, capable of applying advanced process knowledge and creativity to complete complex assignments related to aseptic operations.
You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from an aseptic operations perspective.Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance aseptic operationsLeading and/or providing input to strategic initiatives that will improve and develop Manufacturing processes for the future including Contamination Control and Aseptic Process Simulations (APS)Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as requiredRemain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology.Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility.
Monitor any process trends (Personnel and Environmental Monitoring), including business performance metrics.
Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the futureLead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are conducted and actionable CAPAs, to prevent future reoccurrence, are implemented within agreed timelinesRequirementsBachelor's degree in Microbiology or related discipline with 10 + years' experience in the pharmaceutical industryExperience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products.Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely mannerExcellent Decision-Making skills and confidence to challenge others respectfully and professionally on decisions that impact the manufacturing areaProactive and works well with others in a collaborative, fast-paced goal-driven environmentInteracts well with diverse groups (Manufacturing, Validation, Engineering, Quality etc) and maintains strong working relationships with internal and external collaboratorsDemonstrated ability to coach, mentor and/or cross train colleagues within core technical areasExcellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (e.g.
investigations, procedures, change controls) and good Presentation skills.PackageContract role - Hourly rate €55 - €65 per hourMinimum 12 month contract with the possibility of an extension.
Onsite expectations: The team are required to do a minimal 3 days per week onsite.However, the initial expectations are for you to be more present onsite to help integrating into the team, familiar with the site and projects, and benefit from face-to-face time and meetings.
Depending on their capabilities and speed of development, the long-term goal is to offer 3 days onsite per week.
