- The successful candidate will be responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction.
- Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities.
- Co-ordination, design and execution of equipment qualification and validation as required.
Core Duties and Responsibilities:
- Serve as technical and/or validation support as required for manufacturing and new product introduction.
- Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input into quality notification by authoring/reviewing/approving investigations.
- Execution of equipment commissioning and qualification programs
- Execution of equipment/qualification validation programs; including re-qualification and re-validation
- Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
- Support continuous improvement through Lean Six Sigma methodologies.
- Leading and active participation in projects, system failure investigations and investigation reports,
- Execution/development of change controls
- Contribution to Kaizen events as appropriate.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
- Implement subsequent corrective action through the change management system.
- Serve as technical engineering representative for internal technical group discussions and represent the company at global technical forums.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
- Drive compliance of their Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
- May be required to perform other duties as assigned.
Minimum Qualifications and Experience:
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting.
- Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
- Considerable experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business; in a GMP manufacturing setting.
- Demonstrated technical leadership and delivery of complex cross functional / cross site projects. SME in multiple aspects of aseptic processing.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Equipment and process validation
- Sterile filling processes and equipment
- Proficiency in Microsoft Office and job-related computer applications required
- Lean Six Sigma Methodology experience desired
- Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
- Understand the specific responsibilities of all departments as they relate to ones own department, understanding the business processes ones department supports
- Vendor liaison
- Trouble shooting skills
- Strong change management, effective conflict resolution & negotiation skills
- Business acumen and Strategy development
- Project & Risk management skills
- Progressive people management skills with a focus on Customers and Patients
- Make Rapid, Disciplined Decisions
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.