Senior Process Engineer – ref MQ135

Headcount Solutions is seeking a Senior Process Engineer for our client’s biotech facility in Dublin. Working with the Process Development Commercial Support team, this person will be primarily responsible for:

1. Continuous improvement projects for drug product formulation and vial/syringe filling lines
2. Process support for set up of new vial filling and capping line
3. Product and process investigation support

Other responsibilities include:

• Definition and scoping of all process improvement activities relating to the area.
• Leading continuous improvement programs and productivity initiatives.
• Product impact assessments associated with process deviations.
• Risk assessments and mitigation projects relating to line performance.
• Performing process gap analysis and developing strategies to close gaps.
• Data trend analysis for all performance aspects of the area.
• Troubleshooting performance trends.
• Working with the operational excellence group in implementing OE methods, mentoring project leads and facilitating process improvement teams.
• Review and approval of changes to operating procedures and the change control process relating to the manufacturing lines.
• Supporting new product introduction teams, as a process subject matter expert.
• Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional teams within the organization etc.

Requirements:

• Bachelor’s degree in Engineering, Science or related discipline.
• Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
• Significant relevant industrial project experience.
• Typically 5 years engineering experience in a manufacturing environment.
• Qualification in Lean and 6-sigma methodologies would be an advantage.
• Significant experience in large project related activities, including GMP qualification experience, would be advantageous.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie