Contract Position-5 months
send resumes to: bciociola@covexllc.com

Duties: The primary purpose of this position is to function within the Information Solutions Department as a project leader of the design, development, testing, documentation, validation, and support of approved IS business projects in support of the Industrial Operations areas of the business which includes but not limited to manufacturing, Quality, Supply Chain and engineering. A person in this position may lead projects that are local, regional or global in scope, and that have extensive impact on the business. Examples of the types of systems that the individual will work with include issue tracking systems, data acquisition systems, document management systems, web applications, Laboratory Information Management Systems, SAP, shop floor systems. The majority of the position’s responsibilities are related to system implementation tasks such as: Business case development.; Resource management, including proactive assignment of resources to IS projects; Leadership of project implementation teams; Development of project plans and day to day management of IS projects; Creation and modification of key documents such as user requirements, functional/design specifications, validation protocols, test scripts, various validation reports. Interaction with Sr. Business Analysts and Business Analysts who may manage day to day tasks at a more detailed level; Managing IS and other project team resources across multiple projects to get projects completed; Change management; Management of project budgets via capital and deferred software funds; Coordinated reporting and presentation of project status, resource allocation, and other project-related information to IS and business Ability to work closely with IS quality and business quality to ensure the systems are validated per the GMP requirements.

Skills:

5+ years project management experience working on IT projects.

Experience with implementation of Manufacturing Systems is key, preferably within the pharma industry.
Office Tools

GAMP validation experience is required
Word
PowerPoint
Excel
Visio
MS Project
Experience working with FDA regulated industries

Excellent written and verbal communication skills

Experience in writing user requirements, functional requirements, test scripts and validation protocols for IT applications is critical

Education: BA/BS Science, Information Systems, or Business

9-12 years related experience



Certifications

Preferred: Project Management Institute (PMI) Project Management Professional or IT Project Management Certification