Process Engineer (Senior)

Orion Group Life Sciences are currently recruiting a Process Engineer (Senior) - Hybrid on behalf of our Multinational Biotechnology Client based in South Dublin on initial 12-Month contract with huge potential to extend.

Onsite expectations: Onsite expectations are 3+ days per week. We can provide flexibility in which days the individual is onsite - it'll be in line with the rest of the team. There are weekly meetings with the immediate team on Wednesdays and Friday mornings are usually virtual meetings with the wider department. Core hours: 08:30 to 17:00

Description:

Process Engineer/Scientist required to work within the Process Development Commercial Support team. The team is responsible for providing process and product support to drug product formulation and fill-finish operations as drug product process SMEs

Key responsibilities listed below but primarily the Hiring Manager can foresee support will be needed for the following:

1. Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
2. Key contributor to product and process investigations, responsible for assessing product and process impact.
3. Leads continuous improvement projects to improve process performance and productivity.

The chosen candidate would typically be involved in activities such as (but not exclusively);
* 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.
* 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.
* 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.

The chosen candidate will work in a collaborative manner within the process teams structure and contribute as a member of cross functional teams within the local organization and functional team globally.

Basic Qualifications:
* 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:
* Typically 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.