Aseptic Process Lead

Orion Group Life Sciences are currently recruiting an Aseptic Process Lead on behalf of our Multinational Biopharmaceutical client based in Dun Laoghaire on an initial 12-month contract (with potential to extend).

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 Aseptic Process Lead will continue to build on the site and network aseptic processing knowledge and represent the Dublin site at a global level across the organisations 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.

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 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 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.
• 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.

What you need to apply:

• 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.