Senior Process Engineer - Fill Finish Roll - Core Logic, Inc.

Position Description

Job Purpose:

Multinational Biotechnology Company is seeking a Specialist in critical process parameters and product quality attributes in Pharmaceutical. This individual must be a team member for process development through to product transfer projects. This position is located in Ireland, and relocation is provided.

Responsibilities :

- Support and champion new aseptic vial filling process introduction.
- Technical support and trouble-shooting in support of FAT’s, IQ/OQ/Cycle Development, PV’s and Commercialization.
- Process/product deviation investigation and resolution.
- Product yield and cycle time investigations and optimization with emphases on robust lean approach.
- Support and champion new product introductions.
- Technical representative for assessment and development of process change control and regulatory submission proposals.
- Training delivery and mentoring to build technical capabilities among teams.
- Support capital projects through lifecycle.
- Support of cycle development and validation activities.
- Benchmark practices and performance against best practice in the pharmaceutical and other industries.
- Support equipment reliability and up time – OEE analysis.
- Lead continuous improvement projects and initiatives.

Key Performance Indicators
- Robust Process Parameters cycle developed.
- Efficient Process cycle times.
- Regulatory compliance
- Product yield
- Successful product transfer/introduction
- Continuous improvement activities yielding advancement in quality and reliability.
- Achievement of SMART goals

Knowledge Required for Senior Process Engineer – Fill Finish Role
- Degree in Pharmacy, Engineering or related Science discipline.
- Advanced degree and training an advantage.


Skills & Knowledge

- Strong technical knowledge (theory and practice) of aseptic manufacturing.
- Pharmaceutical process cycle development and product development, transfer and project life-cycle.
- Specific knowledge of sterile secondary pharmaceutical manufacturing processes and technologies including product filter sterilization, Vial Depyrogenation, VHP sterilization, Freeze Drying, CIP/SIP.
- Strong analysis, report-writing and research skills.
- Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
- Strong understanding of regulatory requirements (IMB & FDA).
- Clear understanding of the needs of cGMP and validation (DQ-PQ).
- DOE knowledge desirable.


Experience

- +12 years in pharmaceutical manufacturing and process engineering. Min. 5 years in a sterile process engineering role.
- Experience of the following:
o Equipment engineering runs, cycle development and PV
o Vial filling & Lyophilisation
o Equipment performance – cleaning validation, particle monitoring, thermal mapping. etc.
o Cleaning (CIP/SIP) and sterilization technologies
o Product introduction and transfer
o Cycle time and yield improvement initiatives
o Continuous improvement projects
o Regulatory audit preparation and follow-up
o Equipment and component specification
o Component preparation – autoclaves, etc.
o Direct experience of aseptic process engineering essential. Ideally have fill finish experience.

Please note: We look forward to receiving CV’s for this role from only those with the relevant experience, min 12 years experience in a sterile/aseptic pharmaceutical manufacturing environment, of which 5 years must be in a sterile process engineering role. Please do not apply without the relevant criteria. br/>
Compensation: $152,400

How to Apply

Application Instructions / Send a Resume