Principal Engineer Parenteral Product & Process Development

Career Category

Job Description

Principal Engineer - Parenteral Product & Process Development

Location: IE Dun Laoghaire Co. Dublin

Overview:

Reporting to the Snr. Manager of Process Development (Commercial Support - Inspection) this person will support the Process Development Inspected Drug Product (IDP) Manufacturing Support Pillar at ADL.

This role serves as the technical inspection Subject Matter Expert (SME) and site focal point for commercial IDP operations with a primary focus on PM2 vial and PM3 syringe inspection facilities. The position provides strategic and tactical leadership across the PM2 vial and PM3 syringe inspection operations to ensure a sustained state of GMP compliance and inspection preparedness.

The Principal Engineer will support a team of SMEs and Inspection Leads ensuring inspection related commitments are executed consistently efficiently and in alignment with global regulatory expectations. The scope of responsibilities will include NPI support Process and Productivity improvements in both the automated and manual visual inspection areas supporting the wider inspection network in addition to introduction of new technology with a strong emphasis on automating current manual processes in the inspection area. The successful candidate will be responsible for technical support leadership guidance and management of the IDP Manufacturing Support pillar within the Commercial Support Team.

Key Responsibilities:

• Drives the establishment of visual inspection objectives focusing on regulatory expectations and network alignment.
• Supports New Product Introduction with visual inspection method development and AVI characterization with an emphasis on Continuous Improvement methodology.
• Proposes develops and leads implementation of novel ways of working / productivity initiatives to improve operations; heavily involved in project management of capital programs.
• Supports calculation of defect limit updates for new products and re-evaluation of current products.
• Provides expertise on defects identified during batch inspection and supports defect library updates.
• Participates in unknown defect characterization and supports Visual Inspection development.
• Supports in the development of visual inspection team members.
• Supports in the characterisation and qualification of AVI vision recipes as part of process improvements. Champions the adoption and implementation of innovative / AI-driven progress in the field.
• Provides support for manufacturing and commercial activities.
• Leads or assists in process related deviations exception resolution and root cause analysis to ensure smooth operations & continued supply. Assists in troubleshooting issues with drug product processing technologies and equipment.
• Ensures the team are Audit ready and provides front room support during GMP Audits.
• Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices improvement opportunities and lessons learnt to deliver high-quality manufacturing processes.
• Participates in industry conferences and provides the wider team with readouts from these conferences.
• Deliver against organizational goals and project milestones with a focus on process optimization/continuous improvement new technology integration and support for new product introductions and product lifecycle management.
• Be accountable for developing recommendations on potential paths forward and the clear communication of those recommendations and their rationale to appropriate governance (including risks of proposed and alternate pathways) as well as devising mitigation strategies for risks of final project pathway chosen.
• Moderate international travel might be required (up to 15% of the time)

Basic Qualifications:

• Bachelors degree in Engineering or Life Sciences with 7 years industry experience in a GMP Manufacturing environment or
• Masters degree Engineering or Life Sciences with 5 years industry experience in a GMP Manufacturing environment or
• Doctorate degree Engineering or Life Sciences with 3 years industry experience in a GMP Manufacturing environment

• Experience in visual inspection method development and AVI characterization.

• Experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources assigning tasks presenting milestones deciding cost/benefit analysis).

Preferred Qualifications and Skills:

• BSc in science engineering or equivalent with additional qualifications (Masters /PhD)
• Significant experience in parenteral drug product manufacturing and execution of cross functional complex technical projects.
• Track record of innovation and leading productivity and process improvement.
• Operational knowledge of development of commercial processes and process characterization including the introduction and implementation of new technologies with particular emphasis on automating visual inspection processes.
• Strong mechanical/automation engineering background.
• Advanced proficiency in AVI (Automated Visual Inspection) optimisation and recipe development
• Extensive experience with machinevision systems and automated defectdetection technologies including camera setup lighting optimisation inspectionalgorithm tuning and validation of machine vision based inspection methods.
• Strong analytical and problemsolving skills.
• Thorough knowledge of GMP biotechnology manufacturing.
• Significant understanding and knowledge of cGMPs.
• Awareness and understanding of quality and regulatory industry trends policies and guidelines.
• Proven track record of advancement in an established high performing organization.
• Proven skills in building and maintaining productive relationships with organizational partners such as Manufacturing and Quality Assurance.
• Ability to lead effectively in a highly matrixed organization.
• Excellent communication skills able to work with and influence executive management.
• Strong understanding of validation of biopharmaceutical facilities equipment and process.
• Ability to learn and act on dynamic information at a rapid pace.

About Amgen

Amgen discovers develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980 Amgen was one of the first companies to realize the new sciences promise by bringing safe effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine helping millions of people around the world in the fight against cancer kidney disease rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines Amgen remains committed to advancing science to dramatically improve peoples lives.

Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work our values and everything we do at Amgen. For staff around the world our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in peoples lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel we support a variety of growth opportunitiesfrom training and education to expanding current job responsibilities.

Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race color religion sex national origin protected veteran status or disability status.