Manufacturing Process Specialist

Morgan McKinley; Dún Laoghaire; On-site; EUR 90,000 - 130,000; Full time

Job summary

Morgan McKinley is seeking a Senior Specialist Manufacturing to lead aseptic Drug Product manufacturing processes, including preparation, formulation, filling, lyophilisation and capping. You will own processes, drive continuous improvement, and champion safety, quality and compliance on site.

You will direct investigations, CAPA implementation, and document governance while collaborating with Manufacturing, Validation, Engineering and Quality teams to achieve operational excellence in a

Qualifications

• Bachelor's degree in Science/Engineering or related discipline with 5+ years in aseptic Drug Product Manufacturing.
• Deep knowledge of cGMP and Eudralex Volume 4 Annex 1.
• Proven ability to lead cross-functional teams and manage documentation.

Responsibilities

• Perform as SME and single point of contact on site and network projects to advance aseptic operations with safety, quality and compliance in mind.
• Accountable for process documentation (SOPs, Training, Electronic Batch Records, Risk Assessments) and gatekeeping of control documents.
• Lead strategic initiatives to develop future processes and continuous improvement projects within assigned area.
• Provide expertise to resolve escalated technical issues and support investigations and CAPAs.
• Monitor process trends and business metrics to drive performance improvements.
• Lead or support investigations impacting safety, quality or compliance and ensure timely CAPAs.
• Stay current on systems and processes and advise on adoption of new techniques.
• Ability to lead change from an aseptic operations perspective is a plus.

Skills

Aseptic manufacturing

cGxP compliance

Process ownership

Documentation control

Regulatory knowledge

Education

Bachelor's in Science/Engineering

Job description

Job Description

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.

As a Specialist Manufacturing, 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 concepts, who wants to be challenged and can lead change from a manufacturing operations perspective.

Supporting key areas of the business, the Process Owner Lead will direct initiatives that improve the reliability and efficiency of manufacturing processes in addition to day-to-day support related to unplanned event troubleshooting, investigations, CAPA identification and implementation.

Primary responsibilities:

• Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance manufacturing and aseptic operations through ownership of the assigned processes and taking a proactive approach to safety, quality, and compliance by actively seeking opportunities to remove error traps.
• Accountable for process documentation (e.g., SOPs, Training, Electronic Batch Records, Risk Assessments) in assigned area of responsibility. Gatekeeper (develop, review and update) of process documentation to maintain structure and control over generation and revision ensuring the documents clearly and correctly direct the process.
• Leading and/or providing input to strategic initiatives that will improve and develop processes for the future.
• 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.
• Use subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility. Ensure project timelines are met, challenges identified, 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 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 timeline.
• Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology.
• Ability to lead change from an aseptic operations perspective is a plus.

What you need to apply:

• Bachelor's degree in Science, Engineering or related discipline with 5 + years' experience in aseptic Drug Product Manufacturing or related cGxP manufacturing experience.
• 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 elevate 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.