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Manufacturing and Engineering Specialist
3 weeks ago
We are seeking a highly skilled Process Engineer to join our team in Carlow. As a key member of the Process Engineering Group, you will provide technical support for new product introduction (NPI) and commercial manufacturing.
You will participate in cross-functional teams, liaise with vendors or above-site groups, and lead single-function teams as required. This is an onsite role based in Carlow and is a 12-month contract.
Key Responsibilities
- Design, author, review, approve, and execute qualification/validation documentation and process development studies in line with standard approval processes
- Design, author, review, approve, and execute execution/development of change controls
- Provide technical input into quality notifications by authoring/reviewing/approving investigations
- Execute equipment/qualification validation programs, including re-qualification and re-validation
- Support continuous improvement through Lean Six Sigma methodologies
- Perform root cause analysis of system failures or substandard performance, using standard tools and methods, to resolve machine and system issues
- Serve as technical engineering representative for internal technical group discussions and represent Technical Operations Carlow at global technical forums
- Drive compliance with global policies, procedures, and guidelines, regulatory requirements, and execute cGMP in day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance; document completion, risk assessments, closing out corrective actions, participate in audits and inspections, and proactively highlighting any issues around compliance
- May be required to perform other duties as assigned
Education: Bachelor's Degree or higher preferred; ideally in a Science, Engineering, or other Technical discipline
Experience: Minimum 3 years experience, ideally in manufacturing, GMP setting
Skills: Demonstrated experience of leading technically related projects, knowledge of process monitoring systems, automation systems, operational intelligence & data systems within a GMP manufacturing environment, knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices, equipment and process validation, sterile filling processes and equipment, proficiency in Microsoft Office and job-related computer applications
Personal Qualities: Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and external customers in a team-oriented manner
BenefitsWork Environment: KPC International offers an inclusive environment where you can broaden your experience, perspective, and skills to help make an impact on the lives of others.
Equal Opportunities Employer: KPC – International is an Equal Opportunity Employer.
OthersReferrals increase your chances of interviewing at KPC International. Get notified about new Process Engineer jobs in Carlow, County Carlow, Ireland.
