
Process Equipment Specialist
4 days ago
We are seeking a highly skilled Process Equipment Specialist to enable business growth and manufacturing excellence by designing, developing, delivering, maintaining, and improving fixed assets and operational technologies at the best cost while ensuring the highest efficiency.
The Process Equipment Specialist is responsible for ensuring that process equipment procured within the project is fit for purpose and operational. This includes the entire process from raw material handling to the production of filled and inspected products, including formulation, filling, and automatic inspection.
Key Responsibilities:
- Review equipment specifications and establish in-depth process knowledge to support regular manufacturing in a GMP environment.
- Provide process equipment expertise to support the process lead.
- Develop a comprehensive documentation package to ensure a smooth transition to the receiving organization.
- Train and educate operational personnel on the use and maintenance of equipment.
- Establish asset management processes in collaboration with the engineering organization.
- Contribute to the design and implementation of future process and equipment solutions to ensure world-class operations.
- Work in accordance with developed validation plans, qualification test protocols, traceability matrices, reports, and IQ/OQ/PQ protocols, among other relevant documents.
Qualifications & Experience:
- Extensive experience in pharmaceutical manufacturing.
- Proven experience in process development, improvement, and optimization.
- Strong knowledge of operational environments.
- Hands-on experience with process and production equipment.
- Expertise in technical advanced machines (fully automated), vision systems, infrastructure, and other relevant operational areas.
- Solid understanding of verification and validation processes.
- Familiarity with pharmaceutical and medical device industry regulations, including cGMPs, 21 CFR Part 11, and GAMP5.
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