Process Engineer

Desired Skills: process engineering,Lean Six Sigma,Change Management,kaizen,Product Transfer,MES,SAP

Overview:

The Process Engineer is responsible for introducing new processes and/or products (product transfer). The Process Engineer will develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion. Steer and/or participate in cross-functional investigations on problems/deviations-including defining corrective and preventive actions. Identify, analyse and prioritize technical or business-related processes improvement-opportunities and problems. Initiate and coordinate improvements for technical or business processes, systems and behaviours. Contribute to a data driven decision making process. Ensure effective application of Lean Six Sigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners. Ensures manufacturing operations are continually supported and maintained in compliance with all quality, safety and environmental regulations. Position will receive direction and support.

Job Purpose:

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 company requirements to ensure compliance, safety and reliable supply to our customers.

Principal Accountabilities:

• Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
• Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT
• Be a document system expert; this will include document review, approval and document system work flow 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.
• Required to comply with company 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.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.
• Assist in the management and/or assignment of IPT training if required.

Skills and Knowledge

Typical Minimum Education

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline

Typical Minimum Experience:

• 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

Core Competences:

Technical

o             SAP knowledge and experience required

o             Proficiency in Microsoft Office and job-related computer applications required

o             Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices

o             Report, standards, policy writing skills required

o             Equipment and process validation

o             Sterile filling processes and equipment

o             Lean Six Sigma Methodology experience desired

Business

o             Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner

o             Understand the specific responsibilities of all Carlow departments as they relate to one’s department, understanding the business processes one’s department supports

o             Strong team skills, including ability to coach/develop work teams

o             Excellent training, facilitation and assessment skills

o             Risk management skills

o             Strategy planning and development

o             Demonstrable analytical and systematic problem-solving skills

o             Strong influencing skills

o             Flexible approach

o             Effective time management and multi-tasking skills

o             Proven organizational skills

o             Excellent attention to detail

o             Trouble shooting skills

o             Goal/results orientated

Leadership

o             Focus on Customers and Patients

o             Collaborate

o             Act with Candor and Courage

o             Make Rapid, Disciplined Decisions

o             Drive Results

o             Build Talent

o             Demonstrate Ethics and Integrity

Interested candidates should submit an updated CV. Please click the link below to apply or alternatively send an up-to-date CV howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****