Consultant Qualification and Validation- Deltav

ABOUT ARCONDIS

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,

information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

About us

MISSION

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.
- Take up responsibility to be on field and perform any troubleshooting for automation systems.
- Prepare and perform IQ/OQ, Test plans, SDLC documentation ensuring document meets the standards.
- Develop Automation protocols and assist the C&Q team.
- Ensure and manage the documents from the Vendors are delivered on time ensuring the quality.
- 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.
- Manage the Production equipment from basis design to implementation stage.
- Expected to lead the software design, hardware design of the assigned production equipment.
- Work closely with Automation lead to ensure relevant timelines are met, quality of testing activities and ensure proper documentation is followed.
- Review the hardware panel and instrument selection by the team and ensure it matches the vision of the EVF project.
- Implement the industry standard architecture and panel design by optimizing the cost with the highest quality deliverables.
- Manage the timelines with Vendors and ensure the project costing is kept under control.
- Review the System architecture, hardware/software design specifications, sub-systems interfacing points, detailed point schedules, control panel drawing etc.
- Review and validate technical choices compliance with the design (based on Technical Design Process).
- Ensure documentation relating to the project is properly and promptly dealt with in the correct contractual manner.
- Manage the FAT of the instrument panels, controller panels on the vendor locations and ensure the system is Qualified and maintained throughout the life cycle.
- Works on multiple projects or tasks of moderate scope and complexity as a team member, requiring mínimal supervision.
- Coaching in the field of computerized system validation, hardware qualification and IT compliance.
- Support in business development.

STUDIES

**Profile**:

- Successfully completed scientific or technical studies (for example: Pharmacy, Biotechnology, Engineering, Chemistry)
- At least 5 years practical experience in a Bio pharmaceutical laboratory or production environment
- Very good GMP knowledge and in-depth knowledge of other regulatory requirements (FDA, EU, GxP, ISO13485, GAMP5)
- Must have worked on DeltaV implementation (preferably greenfield).
- Must have worked on 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 about basic networking and setup.
- Knowledge in manufacturing process steps and Fundamental concepts of software programming.
- Must know the principles of electrical networking
- Communication protocols such as Profinet/Ethernet IP are must. Bus communication such as Profibus PA is added advantage.
- Proven SAT experience commissioning the production equipments.
- High degree of quality awareness, strong communication skills and the ability to work in interdisciplinary teams.
- Willingness to travel
- Customer-oriented working