Specialist Manufacturing.

Aphex Group; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Aphex Group in Ireland seeks an experienced Specialist Manufacturing to manage aseptic Drug Product processes including fill/lyophilisation and cGMP compliance. You will apply advanced process knowledge, lead change from a manufacturing operations perspective, and drive continuous improvements.

The role involves acting as SME, directing process documentation, and supporting investigations and CAPA implementation to ensure safety, quality, and compliance across assigned manufacturing operations.

Qualifications

• Bachelor's degree in Science, Engineering or related discipline with 5+ years' aseptic Drug Product Manufacturing or related cGxP manufacturing experience.
• Experience with regulatory compliance in cGMP manufacturing and knowledge of Eudralex Volume 4, Annex 1.
• Proven ability to work in a high-paced matrix organisation and influence change.
• Excellent decision-making and communication skills for cGxP documentation.

Responsibilities

• Perform as a knowledgeable SME and single point of contact on site for projects and programs.
• Lead process documentation and gatekeeping to maintain structure and control.
• Lead and/or support strategic initiatives to develop future processes.
• Identify and lead continuous improvement projects; ensure timelines and communications.
• Monitor process trends and performance metrics to drive improvements.
• Lead investigations and implement CAPAs to prevent recurrence.

Skills

Aseptic manufacturing

cGxP compliance

Regulatory knowledge

CAPA investigations

Documentation

Education

Bachelor's degree in Science, Engineering or related discipline

Job description

Purpose

This role 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 knowlegable subject matter expert, and single point of contact on site and netwrok projects and programs, to advance manufacturing and aseptic operations through ownership of the assigned processes and taking a poractive appraoch to safety, quality and complaiance 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.

Qualifications/Experience

• 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 organisation 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.