This is a senior contracting role that requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.
Primary responsibilities:
- Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance aseptic opera-tions
- Leading and/or providing input to strategic initiatives that will improve and devel-op 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 tech-nical 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
Education + Experience:
- Bachelor's degree in Microbiology or related discipline with 6+ years' expe-rience 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.
- 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
- Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (e.g. investigations, procedures, change controls) and good Presentation skills.
For more information on the role please feel free to contact our specialist engineering recruiter Gerard Crowley by calling 021 2300 300
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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