Process Engineer

Desired Skills: Process engineering,Lean Six Sigma,Change Management,Product Transfer. NPI,CAPAs

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. Works with moderate work direction and is skilled and knowledgeable to the position.

Job Purpose

• Coordinate, execute & document qualification & process studies and additional product programs where applicable.
• Respond to operational and business areas, ensuring compliance with cGMP & regulatory requirements
• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance

Key Accountabilities

• Generation, review and approval of process documentation.
• Execution of development and qualification studies across commercial and non-commercial product. Representing Technical Operations department at cross functional meetings.
• Development and qualification of new processes. Qualification of new equipment where appropriate.
• Lead & support investigations and troubleshooting of process studies as required. Technical support for commercial manufacturing.
• Technical support for new product introduction.
• Ensure compliance with the QMS, industry/company specific standards and regulations. Demonstrate effective communication and interpersonal skills.
• Proactively act to consistently improve personal knowledge and
• Demonstrate an awareness of own capabilities and development
• Lead & support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of MPS processes and tools.
• Application of technical knowledge to enable authoring of technical documents and technical decision
• Support audit readiness, including preparation of story boards, ensuring GMP compliant documents are available, presentation to auditors as required.
• Work collaboratively to drive a safe and compliant culture in
• Participate in driving a high performing & inclusive culture, stimulating personal growth &
• May be required to perform other duties as

Responsibilities:

• Drive to ensure that objectives are effectively achieved, consistent with company & regulatory requirements.
• Respond to & support operational and business areas, ensuring compliance with cGMP and company requirements.
• Ownership & management of change control and other compliance commitments.
• Drive continuous improvement by active participation in, and contribution to, projects and problem- solving including use of MPS processes and tools.
• Ensure & promote that adequate processes and procedures are in place and followed for all process activities.
• Drive business critical projects related to the Technical Operations department. Lead process initiatives/introductions as required.
• Provide expertise & technical support for cross functional programs & investigations Use expanded conceptual knowledge to provide mentoring and guidance
• Understand the fundamental business drivers for the company; uses this knowledge in own work

Education

Typical Minimum Education: Bachelor’s Degree or higher preferred, ideally in a related Science or Engineering discipline.

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****