Manufacturing Specialist – Process Owner (Syringe)

Career Category

Job Description

SiteSyringeFill FinishProcessOwner

Job Summary:

An exciting and rare opportunity has presented for a SiteFill FinishProcess Lead at Amgen Dublin. 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 andCapping.

As aFill FinishProcess 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 the manufacturing operations. You are someone who contributes to the development of new principles and conceptswho wants to be challenged and can lead change from amanufacturing operationsperspective.

Supportingkey areas of the business theFill Finish Process Leadwill directinitiatives that improvethereliability and efficiency of manufacturingprocessesin addition torun the businesssupportrelated tounplannedand/ordisruptive events.

Primary responsibilities:

• Perform as a knowledgeable subject matter expert (SME) and single point of contact on site and network projects and programs to advance Fill Finish manufacturing operations

• Leading and/or providing input to strategic initiatives that will improve and develop processes for the future

• Contributeina team environment to operational issuespertaining toprocesses as they arise and provideexpertiseand support to help resolve escalated technical issues asrequired

• Utilise subject matterexpertisetoidentifyand lead continuous improvement projects in assigned area of responsibility. Ensureproject timelines are met challengesidentified mitigations are in place and communication plans delivered to all stakeholders

• 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 including business performance that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future

• Lead and/or Support investigations thatimpacton safetyqualityand/or compliance of the processes ensuring thorough investigations are carried out and actionable CAPAs to prevent future reoccurrence areidentifiedand implemented within agreed timeline
• Remain current on state-of-the-art for systems and processes and advise on theappropriate adoptionand use of new techniques and technology

What you need to apply:

• Bachelors degree in Science Engineering or related discipline with 10 years experience in the pharmaceutical industry

• Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge ofEudralexVolume 4 Annex 1 Manufacture of Sterile Medicinal Products.

• Proven ability to work in a high paced matrix organization and effectively influence changeand escalate issues professionally andin a timely manner

• Excellent Decision-Making skills and confidence torespectfully and professionally challenge otherson decisions thatimpactthe 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) andmaintainsstrong working relationships with internal and external collaborators

• Demonstrated ability to coachmentorand/or cross train colleagues within core technical areas

• Excellent verbal and written communication skills: Strong Technical writing skills forcGxPdocumentation (eginvestigations procedures change controls) and good Presentation skills.