As IS Support Engineer - PI Specialist you provide operational support of OSI-Soft PI Data Historian system in a GMP (Good Manufacturing Practices) regulated environment. You are supporting the PI System Owner for deploying software, incident management, problem management, life-cycle management, system maintenance including application upgrades, projects, enhancements and security patches.
Your proven overall IT and automation integration knowledge, communication skills will enable you to liaise effectively with customers, vendors and IT and engineering experts locally as well as with other sites worldwide in order to provide IT solutions for clients to ensure that regulatory, business, functional and application specific requirements are met.
You design and deploy new innovative solutions to improve the efficiency of our application environment. You ensure procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements.
- System administration and day-to day support for OSI-Soft PI Data Historian
- Provide support to ensure that all GMP related activities are done right and on time.
- Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimise operations.
- Translates requirements into technical solutions that meet business needs.
- Promotes and develops communication between the business, technical staff and suppliers to integrate cross functional business needs.
- Participating in projects as a system owner.
- Perform testing and develop documentation in support of systems changes
- Creates, Reviews and approves project documentation.
- Maintains knowledge of IS quality and compliance policies, SOPs and associated documents.
- Support, participates in and responds to questions and findings from regulatory and other audits.
- Thorough knowledge and experience withOSI/Soft PI Data Historian:
- PI Server System Management
- PI OPC Interface management
- PI Point creation and editing
- PI AF (PI AF Analytics, Event-Frames and PI Notification)
- PI Visualization (PI Vision)
- PI DataLink
- Knowledgeable regarding FDA GxP and 21 CFR regulations and understand software system validation
- Bachelor degree in Information systems, Computer Science or Life Sciences.
- 5 years of Information Systems (IS) experience within the pharmaceutical or biotech industry.
- 5 years of experience with installing, testing and deploying new IT solutions in an Engineering environment.
- Knowledge and experience of ITIL fundamentals in Service operations and Application life cycle processes.
- Knowledge of change management and validation of computerised systems (e.g. GAMP5).
- Excellent organisation skills, detail oriented and accurate.
- Skilled in working under pressure, must possess good time management skills.
- Fluent in English (both verbal and written).
- Able to communicate ideas in both technical and user-friendly language.
- Experience in developing and executing SOPs, Installation and Operational (IQ, OQ) Protocols.
- Experience in working with solution lifecycle methodologies e.g. Agile and RUP.
- Ability to work in global, cross-functional and virtual teams in different time zones (flexibility in work hrs.).
- Experience with engineering applications
- Industry Standard Technical Certifications a plus : A+ Certification
- Strong customer service skills, ability to work in teams, excellent verbal and written communication
- Ability to understand and challenge business processes, requirements and proposed solutions to help define strategic, robust, and scaleable solutions