Senior Micro Specialist

PE Global is currently recruiting for a Senior Micro Specialist for a leading multi-Pharma client based in Dublin.

This is a 12 month contract position.

Role:

• Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance aseptic operations.
• 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 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 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. 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 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 reoccurrence, are implemented within agreed timelines

  Requirements:

• 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 ex-ternal collaborators
• Demonstrated ability to coach, mentor and/or cross train colleagues within core technical areas
• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (e.g. investigations, procedures, change controls) and good Presentation skills.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up to date CV to Niamh.mcdonald@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***