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OSISoft PI Specialist

  • Job reference: 933624
  • Location: Breda, North Brabant
  • Salary: Negotiable
  • Job type: Contract
  • Sector: IT, Life Sciences
  • Date posted: 21/01/2021

Orion Group Life Sciences are looking for OSISoft PI Specialist for our Multinational Pharmaceutical client based in the Breda Area (Netherlands) on an initial 6-month contract.

Job Purpose

As OSISoft PI Specialist you provide operational support of OSI-Soft PI Data Historian system in a GMP (Good Manufacturing Practices) regulated environment and are part of OSISoft PI focused projects (new business functionalities, upgrades, architecture management). You are working with the Client's OSISoft PI System Owner for deploying software, project deployments and implementations, incident management, problem management, life-cycle management, system maintenance including application upgrades, projects, enhancements and security patches.

Main Responsibilities of the role

* 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 optimize 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 Amgen 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.

Desired Experience and Background of the successful candidate

  • Thorough knowledge and experience with OSI/Soft PI Data Historian:
    * Knowledgeable regarding FDA GxP and 21 CFR regulations and understand software system validation
    * 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 computerized systems (e.g. GAMP5).
    * 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 scalable solutions

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.