Process Engineer

Serve as technical support for manufacturing and new product introduction.

· Design/Author/Review/Approve/Execute process simulations studies in support of new

product introduction and ongoing manufacturing support.

· Provide technical input into quality notification by authoring/reviewing/approving

Process Simulation related investigations.

· Design/Author/Review/Approve/Execute process simulation 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 to support the Process Simulation process

· 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

represen at global technical forums in relation to process

simulations.

· Participate and/or lead cross functional or single function teams including liaising with vendors

or above site groups.

· Drive compliance of 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.

· Work collaboratively to drive a safe and compliant culture in Carlow.

May be required to perform other duties as assigned.

Core Competences

Technical

· 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

Business

· 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 Carlow departments as they relate to ones

own department, understanding the business processes ones department supports

· Customer service

· Vendor liaison

· Strong influencing skills

· Self-motivated

· Flexible approach

· Effective time management and multi-tasking skills

· Excellent attention to detail

· Trouble shooting skills

· Data Analysis

· Goal/results orientated

· Demonstrable analytical and systematic problem solving skills

· Training skills

· Strong change management skills

· Effective conflict resolution skills

· Negotiation skills

· Business acumen

· Strategy development

· Project management skills

· Risk management skills

· Progressive people management skills

· Ability to effectively manage complex projects across multiple disciplines

Typical Minimum Experience:

· 3 – 5 year’s operations experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.

· Demonstrated ability to coach and lead change

· Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment

Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical

Discipline