Process Engineer

Role Summary:

• Our client, a state-of-the-art drug substance and drug product manufacturing facility based in Co. Carlow, is seeking a Process Engineer to support their team on site for an 11-month contract.
• The successful candidate will 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.

Core Duties and Responsibilities:

• 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.
• 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.
• Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
• 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

Minimum Qualifications and Experience:

• Bachelor’s Degree or higher, ideally in a related Science or Engineering discipline.
• Experience in a similar position is advantageous
• Demonstrate effective communication and interpersonal skills
• Experience of effective application of LeanSixSigma and Change Management tools
• Experience working cross functionally with excellent teamwork skills

Please note, we do not require agency assistance with this role.