Upstream Operations Support Specialist

Orion Group Life Sciences are currently recruiting an Upstream Operations Support Specialist on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-Month contract with potential to extend.

A fantastic and exciting opportunity has arisen for an Upstream Operations Support Specialist. The role will provide key operational support to the Upstream shift teams to ensure right first-time execution/delivery of manufacturing of batches. The Upstream Operations Support Specialist will support routine operations in the areas of safety and GMP compliance and will report to Upstream Operations Support Lead.

This position will play a pivotal and critical role in the manufacture of biologics-based medicines, including immuno-oncology.

Role Functions:

• As an Operations Specialist, you will work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production in Upstream Operations. This requires the delivery of process excellence and reliability across all areas of the IPT.
• Support Shift Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training, including coordination of daily production activities.
• Manage & track creation & updates to Standard operating Procedures (SOPs) Work Instructions (WI’s) for New Product Introduction
• Ownership of CAPAs
• Support compliant operations through management of materials used in Upstream Operations.
• Data analysis supporting operations in safety quality delivery and cost
• Link to finance department for monthly materials reporting and approvals
• Liaise with stakeholders including Shift Operations, Tech Ops, Quality Assurance
• Collate and analyse downtime tracking data and link to problem solving.
• Provide Communication updates to manufacturing shift teams.
• Co-ordinate and support Audits including preparatory work.
• Coordinating and authoring Quality Notifications and Corrective and Preventive Actions (CAPAs). Ensuring accurate and timely documentation and updates to maintain compliance with quality standards and regulations.
• Co-ordination of Contractors and Visitors to BDS.

Knowledge/Skills/Education

• Working knowledge of SAP
• Experience with Qualified Document Management systems
• Self-motivated with excellent organizational skills
• Ability to interact with multiple stakeholders across numerous departments.
• Ability to work independently and as part of a team.
• Advanced soft skills e.g. MS Word, Excel, PowerPoint to generate metrics, presentations as applicable
• Excellent communication skills
• Degree or 3rd level qualification (Science, Engineering).

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.