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