Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Senior Automation/IS Engineer - 21CFR/MES - Pharmaceutical

Eingestellt von Quanta Consultancy Services

Gesuchte Skills: Engineering, Engineer, Client, Network

Projektbeschreibung

Leading Bio-Pharmaceutical plant based in Holland have a long term contract requirement for an experienced Senior Automation/IT Engineer to provide support for the computerised systems in a GMP environment.

Working within the packaging & distribution facility supported by the Operations, Customer Service and Demand, Information Systems and Quality departments, we are looking for a Senior automation IS Project Engineer who will be responsible for deploying software, incident management, life cycle management, system maintenance - including application upgrades, projects, enhancements and security patches.

Your proven overall IT and engineering knowledge, communication skills and project Management experience will enable you to liaise effectively with clients, users and IT experts (application, network, database, etc.) locally as well with other sites worldwide in order to provide IT solutions for clients.

The Senior automation IS project engineer coordinates small projects or serves as a project member in larger projects.

Tasks will include:

- Designs and deploys new innovative solutions to improve the efficiency of business processes.
- Ensures procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements.
- Works with other IT and engineering experts, vendors and customers to ensure regulatory

(eg validation), business, functional and application specific requirements are met. - Act as Project Manager in small projects.

Functional Responsibilities

- Maintains in depth knowledge of information systems technology and engineering.
- Mentors and trains department staff members.

Client responsibilities

Demonstrates knowledge about IT and Engineering processes.
Participates in evaluating business applications and processes.
Able to recognise problems and communicate solutions conceptually.
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.
Facilitates process mapping sessions for complex business processes.
Facilitates the implementation of new programs and processes in client area.
Creates project artifacts according to project requirements.
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

Basic Qualification Required:

10 years of Information Systems (IS) experience preferable within the pharmaceutical or biotech industry.
10 years of experience with installing, testing and deploying new IT solutions in an Engineering environment.
Experience in automation or equipment engineering combined with Information Systems (IS).
Experience as a project-manager in implementing IT solutions on an application level.
Builds, leads, and coaches project teams throughout project life cycles.
Experience in use of MS Project (project scheduling, time management).
Knowledge of change management and validation of computerised systems (eg GAMP5).
Experience in developing and executing SOPs, Installation and Operational (IQ, OQ) Protocols.
Fluent in English (both verbal and written).
Excellent organisation skills, detail oriented and accurate.
Skilled in working under pressure, must possess good time management skills.
Skilled in working effectively in a team Matrix environment.
Able to communicate ideas in both technical and use-friendly language.
Experience in working with solution life cycle methodologies eg Agile and RUP.
Used to System Change Management procedures in a complex controlled environment.
Strong analytical skills and project execution experiences.
Ability to understand and challenge business processes, requirements and proposed solutions to help define strategic, robust, and scalable solutions.

Preferred:

Industry Standard Technical Certifications a plus: A+ Certification
Microsoft Certified IT Professional (MCITP)
Knowledge and understanding of 21 CFR Part 11 Compliance
Strong customer service skills, ability to work in teams, excellent verbal and written communication
Knowledge and experience with MES systems preferable PASX
Knowledge and experience with Serialisation
Knowledge and experience with environmental monitoring systems
Knowledge and experience with Warehouse applications (Vanderlande/Miniload)

Projektdetails

  • Einsatzort:

    Niederlande

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Quanta Consultancy Services