Process Engineer (Aseptic Processing)

Role Summary:

• Our client, based in Co. Tipperary, has an urgent requirement for a Process Engineer to provide specialist support for equipment qualification and operations initially in a start-up environment.
• The Process Engineer is also required to provide technical support for clean utilities and facility qualification as needed.
• This role focuses on resolving technical and engineering issues, providing technical support and troubleshooting, investigation closeout and maintaining the qualification status of a new aseptic plant and equipment.

Core Duties and Responsibilities:

• Support the design and implementation of aseptic processing technologies and procedures.
• Lead process equipment commissioning and qualification activities for a new aseptic facility.
• Develop process understanding; perform gap analysis and FMEAs
• Lead contamination reduction and investigation projects
• Lead major equipment related investigations and implement equipment CAPA and performance improvements.
• Develop and support aseptic practice training as necessary.
• Drive the adoption of new aseptic processing technologies and best practices in manufacturing processes
• Develop metrics to measure and continually improve aseptic processing practices within manufacturing and process development.
• Provide technical guidance on change controls and how they might impact aseptic processing.
• Prepare and review technical and compliance testing protocols and reports.
• Provide technical training on process and equipment as required by Operations.

Minimum Qualifications and Experience:

• Degree in Chemical, Industrial or equivalent Engineering discipline
• Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage
• A minimum of 4-5 years industrial Engineering experience of which 2-3 years will be in an aseptic processing environment.
• Experience in Fill-Finish of injectable products is highly desirable.
• Start-up/pilot plant skills – Applicants should be energetic and personable, organized, self-motivated, and capable of working independently, and as part of closely knit teams
• Technical knowledge (theory and practice) of aseptic manufacturing; experience working in high technology / Engineering disciplines with exposure to Aseptic processing.
• In depth understanding of Autoclave, CIP and SIP systems, and Clean Utilities.
• Design of Experiment and associated statistical techniques
• Pharmaceutical product development project life-cycle experience
• Strong report-writing and verbal communication skills
• Research skills
• Innovation and creativity skills; demonstrated ability to provide technical solutions for complex problems through equipment knowledge.
• Project management skills
• Structured Problem-solving skills – Statistical
• Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA’s (Failure Mode effects analysis) etc.
• Strong knowledge of current Good Manufacturing Practices and US / EU regulations.
• Ability to act as Process Engineer SME in regulatory audits

Please note, we do not require agency assistance with this role.