Automation Specialist

Vor 4 Tagen

Reinach AG, Aargau, Schweiz Arcondis Vollzeit
About the Role

We are seeking a highly skilled Automation Specialist to join our team at Arcondis. As a key member of our team, you will be responsible for devising automation solutions that improve productivity, business operations, and safety/quality standards.

Key Responsibilities
  • Support the development of automation solutions that enhance productivity and efficiency
  • Assist lead engineers in design deliverables and automation documentation activities
  • 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, analyze, and evaluate system functions and processes to deliver validation deliverables
  • Develop and execute FAT/SAT test scripts, qualification protocols, and reports based on industry best practices
  • Collaborate with vendors to ensure data storage and integrity are managed properly according to standards
  • Implement the latest off-the-shelf technology to manage product life cycles according to industry standards
  • Review and understand client procedures and implement relevant procedures at the right time
  • Approve technical documentation from vendors as necessary
  • Stay up-to-date with new technologies and present them for automation implementation
  • Work closely with the Automation lead to ensure relevant timelines are met, quality of testing activities, and proper documentation is followed
  • Lead software design and hardware design of assigned production equipment
Requirements
  • Successfully completed scientific or technical studies (e.g., Pharmacy, Biotechnology, Engineering, Chemistry)
  • At least 5 years of practical experience performing CSV activities in a Bio pharmaceutical laboratory or production environment
  • Responsible for the design and delivery of DeltaV systems on site
  • Experience in Emerson DeltaV DCS and DeltaV Batch is required
  • Excellent knowledge of GMP and other regulatory requirements (FDA, EU, GxP, ISO13485, GAMP5)
  • Foundational understanding of ICH Q7/Q9, 21 CFR Part 11, EU Annex 11, and regulatory requirements
  • Experience in DeltaV implementation (preferably greenfield)
  • Experience in Bio process equipment such as Bioreactor, Chrome, VI, Filtration skids, etc.
  • Must have professional experience in CSV and/or qualification of hardware as well as in IT Compliance topics
  • Knowledge in manufacturing process steps and fundamental concepts of software programming
  • Proven SAT experience commissioning production equipment
  • High degree of quality awareness, strong communication skills, and ability to work in interdisciplinary teams
Work Eligibility Notice

Due to work eligibility restrictions for this location, the recruitment team will only process applications from valid Employment Pass holders and residents.

Arcondis is an equal opportunity employer and welcomes applications from all qualified individuals. We thank all applicants for their interest in joining our team; however, only those eligible for Singapore work location and selected for an interview will be contacted.

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