Process Engineer

Job title:

Process Engineer

Company:

Asset Recruitment

Job description

Process EngineerAsset 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.