Dynamic Process Improvement Specialist

We are seeking a highly skilled Senior Engineer to join our team in Cork/Dublin. This is an exciting opportunity to work with a dynamic team and contribute to the development of innovative drug products.

Job Description:

• As a Senior Engineer, you will be responsible for providing technical expertise to support the filling operations, working closely with cross-functional teams to achieve project objectives.
• You will develop process comparisons, risk assessments, and manage DP technical and manufacturing risks and identify appropriate mitigations.
• Author technical reports to support DP process and product characterisation.
• Manage change control, deviations, and CAPAs through the quality management system until closure.
• Facilitate investigations, root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations.
• Initiate and lead process improvement projects, involving cross-functional teams.
• Support the technical delivery of new product introductions and tech transfer projects by closely collaborating with cross-functional project teams, ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery.
• Assist with PPQ campaign readiness and provide in-person, on-the-floor execution support for technical runs and PPQ campaigns as required.
• Support on-site implementation of changes and DP launch activities.
• Support aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management, overseeing new product introductions from development batches to approval and commercialization.
• Assist with regulatory inspections and present technical topics related to process aspects of assigned products when necessary.

Required Skills and Qualifications:

• Strong understanding and hands-on experience in MSAT or process development or technology transfer, background in large-scale processing of biologic drug products.
• Possess a strong understanding and hands-on experience in MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products.
• Have a solid understanding of regulatory requirements and guidelines.
• Proficient in technical writing.
• Demonstrated ability to build strong partnerships and work effectively with diverse team members in a dynamic environment.
• Excellent organizational, interpersonal communication, and problem-solving skills.
• Capable of identifying, communicating, and implementing continuous process improvements.
• Ability to multi-task and manage tight timelines in a fast-paced environment.
• Able to work on the manufacturing floor for extended periods during the execution of technical protocols.
• Excellent written, verbal, and presentation communication skills.
• Strong analytical skills and sound judgment.
• Effective decision-making skills, with the ability to negotiate and balance decisions and priorities across multiple stakeholders' needs.
• Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project, etc.

Benefits:

• Equal Opportunity Employer/Veterans/Disabled
• All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Others:

• Education and experience: A degree in engineering or science with relevant experience in the biotech/pharmaceutical field.