Automation and Validation Specialist
vor 1 Woche
We are seeking an experienced Automation and Validation Specialist to join our team at Arcondis. This role will be responsible for devising automation solutions that improve productivity, business operations, and safety/quality standards.
About the CompanyArcondis is a global consulting company with a focus on the healthcare and life science industries. We have a global footprint with offices in North America, APAC, and across Europe.
Key Responsibilities- Support the development of automation solutions that improve productivity and quality standards.
- Assist lead engineers in design deliverables and provide automation documentation services.
- Provide Computerized System Validation (CSV) and Computerized System Assurance (CSA) consulting services for DeltaV systems.
- Work with the DeltaV team to develop systems architecture, specifications, controls strategies, and sequence of operations.
- Review and analyze system functions and processes to deliver validation deliverables.
- Develop and execute FAT/SAT test scripts, qualification protocols, and reports based on industry best practices and client documentation.
- Collaborate with vendors to ensure data storage and integrity management aligns with industry standards.
- Implement off-the-shelf technology to manage product life cycles according to industry standards.
- Bachelor's degree in a scientific or technical field.
- At least 5 years of practical experience in CSV activities in a bio-pharmaceutical laboratory or production environment.
- Experience in Emerson DeltaV DCS and DeltaV Batch is required.
- Excellent knowledge of GMP and regulatory requirements (FDA, EU, GxP, ISO13485, GAMP5).
- Familiarity with ICH Q7/Q9, 21 CFR Part 11, EU Annex 11, and regulatory requirements.
- Experience in DeltaV implementation and bio-process equipment.
- Strong communication skills and ability to work in interdisciplinary teams.
As an Automation and Validation Specialist at Arcondis, you can expect a competitive salary range of SGD $80,000 - $110,000 per annum, depending on your experience. Our company culture values innovation, teamwork, and continuous learning.
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