Process Engineer

13 Feb 2018
06 Mar 2018
Justin Pankinas
Job Type
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.

Principal Accountabilities:
Serve as technical support 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/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 technical Operations Carlow 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 Clients 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.

Skills and Knowledge:

Typical Minimum Education:
Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline

Typical Minimum Experience:
Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting

Core Competences:
*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 Carlow departments as they relate to ones own department, understanding the business processes ones department supports
*Vendor liaison
*Strong influencing skills
*Flexible approach
*Effective time management and multi-tasking skills
*Trouble shooting skills
*Data Analysis
*Demonstrable analytical and systematic problem solving skills
*Training skills
*Strong change management skills
*Negotiation skills
*Strategy development
*Project management skills
*Risk management skills
*Ability to effectively manage complex projects across multiple disciplines Using the Job Description Menu, select the appropriate business competencies in line with the role e.g. communication skills, decision making skills, financial awareness etc.

*Focus on Customers and Patients
*Act with Candor and Courage
*Make Rapid, Disciplined Decisions
*Drive Results
*Build Talent
*Demonstrate Ethics and Integrity

For more information contact

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