Consultant Qualification and Validation- DeltaV

vor 4 Wochen

Reinach, Schweiz Arcondis Vollzeit
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.Tasks and responsibilities- Support the development in devising automation solutions that improve productivity, business operations and safety/quality standards. 
- Assist the lead engineers in terms of Design deliverables and proactively support the automation documentation activities. 
- Provide Computerized System Validation (CSV) / Computerized System Assurance (CSA) consulting services for DeltaV systems. 
- Work with DeltaV team in development of systems architecture, specifications, controls strategies, sequence of operations through all design stages. 
- Review, analyse 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 and Client’s / Solution Provider’s documentation system. 
- Work with Vendors to support the Digitalization and IIOT to ensure the data storage and integrity is managed properly as per Standards. 
- Work with suppliers to implement the latest off the shelf technology to ensure the product life cycle is managed as per industry standards. 
- Read and understand the client’s Procedures and implement right procedures at right time. 
- Review the technical documentation from vendors and approve as necessary. 
- Urge to learn new technology and present the latest technologies available for automation and implement them as necessary. 
- Work closely with Automation lead to ensure relevant timelines are met, quality of testing activities and ensure proper documentation is followed. 
- Expected to lead the software design, hardware design of the assigned production equipment. 
- Works on multiple projects or tasks of moderate scope and complexity as a team member, requiring minimal supervision.  
- Coaching in the field of computerized system validation, hardware qualification and IT compliance.Your profile- Successfully completed scientific or technical studies (for example: Pharmacy, Biotechnology, Engineering, Chemistry). 
- At least 5 years and above 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 in 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 the field of 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 the production equipment. 
- High degree of quality awareness, strong communication skills and the 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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