Senior Process Engineer
| Reference: | SMC 2974 |
Location: |
Dublin
|
| Qualification: | Degree | Experience: | See description |
| Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
Senior Process Engineering | Biologics Drug Substance
We're currently recruiting for an opportunity with a leading multinational biopharmaceutical manufacturer based in Dublin.
The position is based within an established large-scale biologics drug substance manufacturing facility supporting the production of medicines for global markets.
This opportunity will suit an experienced Process Engineer or MS&T professional with a strong background in upstream cell culture and/or downstream purification, commercial manufacturing support and GMP process improvement.
Responsibilities
- Support upstream and downstream process engineering activities across biologics drug substance manufacturing.
- Provide technical support for commercial manufacturing, process troubleshooting and continuous improvement.
- Support technology transfer, process characterisation, qualification and validation activities.
- Analyse manufacturing process trends using CPV, SPC and statistical data analysis methodologies.
- Investigate process deviations and support the implementation of corrective actions and change controls.
- Support experimental studies focused on improving process yield, performance and robustness.
- Author and review batch documentation, technical reports and regulatory documentation.
- Collaborate with MS&T, manufacturing, quality, analytical and regulatory teams.
- Support risk assessments, FMEA activities and Lean Six Sigma initiatives.
- Contribute to GMP compliance, audit readiness and regulatory inspections.
Education & Experience
- Degree in Biological Sciences, Chemical Engineering, Biological Engineering, Chemistry or a related discipline.
- Minimum five years' relevant experience with an MSc or seven years with a BSc, with PhD applicants considered in line with the role requirements.
- Experience in upstream cell culture and/or downstream purification of biologics.
- Strong understanding of commercial GMP drug substance manufacturing.
- Experience supporting process investigations, technical troubleshooting and change controls.
- Knowledge of technology transfer, PPQ, process validation and continued process verification.
- Experience with statistical analysis tools such as JMP or Design Expert would be advantageous.
- Strong technical communication and cross-functional collaboration skills.
This is an opportunity to contribute to commercial biologics manufacturing within a strategically important facility, with involvement in process science, operational performance and product lifecycle activities.
For further information or a confidential discussion, contact:
Seán McCarthy
[email protected]