Aseptic Manufacturing Lead - Microbiologist
Global Biotechnology company based in south Dublin, Ireland is looking for Aseptic Process Lead - Microbiologist.
The successful candidate will be responsible to perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance aseptic operations.
The Job:
* Leading 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 to a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required.
* Remain 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.
* Identify actions that will enable the process, and the Manufacturing areas better achieve and surpass metrics in the future.
* Lead 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 re-occurrence, are implemented within agreed time-lines.
Have You:
* Bachelor's degree in Microbiology or related discipline with 5+ years experience in the pharmaceutical industry.
* Experience 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 manner.
* Excellent Decision-Making skills and confidence to challenge others respectfully and professionally on decisions that impact the manufacturing area.
* Proactive and works well with others in a collaborative, fast-paced goal-driven environment.
* Interacts well with diverse groups (Manufacturing, Validation, Engineering, Quality etc) and maintains strong working relationships with internal and external collaborators.
* Demonstrated ability to coach, mentor and/or cross train colleagues within core technical areas.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing
Industries
Pharmaceutical Manufacturing
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