Process Engineer

Summary:
An exciting and rare opportunity has arisen for an Aseptic Process Owner Lead at our Dublin based pharmaceutical client. 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.

Responsibilities:

• 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.

Qualifications & Experience:

• Bachelor’s degree in Microbiology or related discipline with 10 + 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.
• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (e.g. investigations, procedures, change controls) and good Presentation skills.