Process Engineer

Process Engineer Asset Recruitment is seeking a Process Engineer for a 12-Month contract position with our client, a global biopharmaceutical company, for their site in South Dublin.

The team is responsible for providing process and product support to drug product formulation and fill-finish operations at the site as drug product process SMEs.

Responsibilities

• Provide daily operational support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.

• Contribute to product and process investigations, responsible for assessing product and process impact.

• Leads continuous improvement projects to improve process performance and productivity.

• Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.

• Assess product impact associated with proposed changes to commercial processes under the change control process.

• Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.

• Review and approve changes to operating procedures, electronic batch records, and product documentation.

• Risk assessments and mitigation projects relating to line performance.

• Perform process gap analysis and developing strategies to close gaps.

• Data trend analysis for all performance aspects of the area.

• Troubleshooting performance trends.

Requirements

• Bachelor's or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 3 years of directly related experience.

• Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.

Preferred Qualifications

• 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation

• Qualification in Lean and 6-sigma methodologies would be an advantage.

• New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.

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