Process Engineer

Desired Skills: Engineering,GMP,Lean,NPI,Process Engineering,CAPAs,Change Management

Overview:

The Process Engineer is responsible for introducing new processes and/or products (product transfer). You 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 prioritise 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.

Responsibilities:

• 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
• 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 capability.
• Demonstrate an awareness of own capabilities and development needs.
• 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 making.
• 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 Carlow.
• Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
• May be required to perform other duties as assigned.
• Accountable for contribution to ensure that objectives are effectively achieved, consistent with company & regulatory requirements.
• Respond to Operational and business areas, ensuring compliance with cGMP and company requirements
• Support continuous improvement by active participation in, and contribution to, projects and problem- solving including use of MPS processes and tools.
• Ensure that adequate processes and procedures are in place and followed for all relevant process activities.
• Support business critical projects related to the Technical Operations department.
• Provide technical support for cross functional programs & investigations

Qualifications:

This is an entry level role – candidates will ideally have an Engineering degree and 1+ years of experience in the pharma industry.

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****