MES Project Manager

START DATE: ASAP

HOURS A WEEK: 40 hours

DURATION: 12 months +

LOCATION: Breda, the Netherlands

The Senior systems specialist provides support for computerized systems in a GMP (Good Manufacturing Practices) regulated atmosphere and will be responsible for deploying hardware and software, incident management, life cycle management, system maintenance including application upgrades, projects, enhancements and security patches.

The Senior systems specialist coordinates small projects or serves as a project member in larger projects. Has the discipline and technical knowledge to work independently and take on responsibilities. 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/EMEA and other regulatory requirements. Works with other IT experts, vendors and customers to ensure regulatory (eg validation), business, functional and application specific requirements are met.

RESPONSIBILITIES

- Demonstrates thorough knowledge of objectives and processes for the local business applications
- Collaborates with client to collect and analyze changes required to business applications
- Responsible for acting as the interface with the client to establish all connections
- Promotes and develops communication between the business, technical staff and suppliers
- Facilitates process mapping sessions for complex business processes
- Facilitates the implementation of new programs and processes in client area

QUALIFICATION:

- 10 years of Information Systems experience within the pharmaceutical or biotech industries
- 10 years of experience with installing, testing and deploying new IT solutions
- 10 years of experience with Microsoft OS technologies for corporate desktop and server
- Strong experience in automation or equipment engineering combined with Information Systems
- Builds, leads, and coaches project teams throughout project life cycles
- Experience in use of MS Project
- Knowledge of change management and validation of computerized systems (eg GAMP5)
- Experience in developing and executing SOPs, Installation, and Operational (IQ, OQ) Protocols
- Skilled in working under pressure, must possess good time management skills
- 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

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 Serialization
- Knowledge and experience with environmental monitoring systems
- Knowledge and experience with Warehouse applications ( Van der Lande/Miniload)

WHAT DO YOU NEED TO DO?

If you're interested in this job please contact Ashley Groeneveld or (see below)