Operations Engineer
Job Summary
AMTSOL:
A Leader in Life science Manufacturing Technology solutions we are looking for top talent to be part of the dynamic team and drive the growth of the business.
Role Overview:
The Operations Engineer supports the set-up and running of media and buffer operations on the manufacturing shop floor working across MES SAP and distributed control-system platforms to deliver compliant well-documented production processes. The role spans day-to-day operational support and project delivery activities including commissioning water-run and engineering-run phases and material preparation within a GMP-regulated environment.
Key Responsibilities
- Set up and support media and buffer operations on the shop floor.
- Develop and maintain MES work instructions and electronic batch records for buffer and media.
- Review and test MES process instructions to ensure accuracy and compliance.
- Create and maintain SAP master data for buffer and media.
- Perform gap assessments and support implementation of controls.
- Author and update process SOPs and related documentation.
- Author review and approve validation protocols and reports and lead execution activities.
- Support commissioning water-run and engineering-run phases and project tasks related to material preparation
Requirements
- Degree in Engineering Life Sciences or a related discipline (or equivalent experience).
- Minimum 5 years relevant experience in GMP manufacturing or operations.
- Hands-on experience setting up and running media and buffer operations.
- Practical MES experience ideally including new MES project delivery.
- Experience with DeltaV or similar distributed control systems.
- Experience in new product transfer / introduction to manufacturing systems and shop-floor operations.
- Working knowledge of SAP master data for buffer and media.
- Good understanding of GMP and data integrity for electronic systems.
- Strong problem-solving and communication skills.