Process Engineer

Contract: 11 month contract
Hours: Full-time, 5 days on site
Salary: To be discussed
Location: Co. Carlow

In this role, you will be responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with the company's requirements.

Responsibilities:

• Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
• Be a document system expert; this will include document review, approval and
• document system workflow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls. Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
• Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
• Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.
• Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.

Skills & Knowledge:

• Bachelor's Degree or higher preferred; ideally in a Science, Engineering or
• other Technical discipline
• Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
• SAP knowledge and experience required
• Proficiency in Microsoft Office and job related computer applications required
• 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
• 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.
• Strategy planning and development
• Demonstrable analytical and systematic problem solving skills

Contact: Louise Catherine Kelly | [email protected]