Principle Consultant

ROBERT STEELE

203-***-**** *** Magnolia Road

203-***-**** (mobile) Milford, CT 06461 ******@*********.***

Areas of Expertise

Project Management Computer Validation EDMS Administration

Software Integration Change Control Technical Writing

Application Support FDA 21 CFR Part 11 Business Liaison

Regulatory Publishing Document Management SDLC

Professional Experience

2018 – Present Shoreline Consulting of CT, Milford, CT

Principle Consultant

As an accomplished IT Professional with over 20 years of experience in Life Sciences, I provide numerous roles for clients ranging from IT Support, Business Liaison, Compliance Validation and Project/team Management. Industries include Pharmaceutical and Bio-technology. Areas of focus include Regulatory Affairs, Quality & Manufacturing, and Information Technology.

2014 – 2017 Alexion Pharmaceuticals, New Haven, CT

Sr. Manager, Applications Administrator, Information Technology

A key role within the project team to rollout FirstDoc as a Global Document Management System for Manufacturing and Research & Development. Modules include:

FirstDoc for Research & Development

FirstDoc for eTMF

FirstDoc for Quality & Manufacturing

Shortly after ‘go live’, responsibilities include:

Provide Level I, II and II support.

Manage enhancements/bug fixes via Change Control.

Recruit and manage staff extenders/consultants.

Migrate new content into FirstDoc.

Liaise with various global business functions.

2007 - 2014 Purdue Pharma, Stamford, CT

IT Lead – Regulatory Systems, Information Technology

IT Lead for Regulatory Systems projects. Major accomplishments include managing the development, implementation, and delivery of several Submission and Report Publishing Systems. Tasks included:

Act as a liaison between IT, ISQA, and the Business.

Apply company-approved SDLC throughout the course of the project.

Create and update project plans/timelines.

Manage project budget expenditures.

Ensure all required validation deliverables are completed and approved.

Prepare Statement of Work & Confidentiality Agreements for consultants, and processing them through Legal (as needed).

Validation Specialist/Technical Writer authoring various QA validation documents, complying to company SDLC standards, GxP guidelines, and FDA 21CFR Part 11.

2005 - 2007 UBS Investment Bank, Stamford, CT

Level 2 Support Analyst – Content Management & Search, Information Technology

A member of a global team providing 24/5 Documentum support in multiple regions (London, Zurich, North America, Australia and Asia/Pacific). Global DMS environment consists of over 100 docbases (DEV, UAT, QA and Production) in a distributed content configuration.

1998 - 2005 Purdue Pharma L.P., Stamford, CT

Sr. Systems Analyst – Regulatory Systems, Information Technology

IT Lead for Regulatory Systems projects. Major accomplishments include managing the development, implementation, and delivery of several Submission and Report Publishing Systems.

Validation Specialist/Technical Writer authoring various QA validation documents, complying to company SDLC standards, GxP guidelines, and FDA 21CFR Part 11.

System Administrator/System Support for production systems. Day-to-day responsibilities include user account management, resolving Help Desk calls, and addressing system issues. Short-term responsibilities include applying system enhancements/upgrades via Change Control, testing of patches/service packs prior to production deployment, Disaster Recovery planning & testing, cross-training, updating Systems Operations Manuals, etc.

Major Accomplishments

2016 Cloud Migration – Played an integral role in moving the entire FirstDoc EDMS environment into the Cloud. This was achieved in 3 phases – DEV, TEST and PROD – a total of 54 servers. All phases were conducted under Change Controls, over a 3 month period.

2015 Migration Center Deployment – By bringing this migration tool in-house, the organization was no longer dependent on 3rd party vendors to facilitate future migrations into FirstDoc. Major benefits include substantial cost-savings and flexibility.

2014 FirstDoc 6.4 Deployment – This global project consisted of CSC’s R&D, eTMF and Q&M modules, and was deployed initially to 400+ users. The environment included several production repositories, full-text indexing, rendering, annotations and SharePoint. Migration of content stemmed from NextDocs, file shares and Stellent repositories.

CYA Smart Recovery – Shortly after ‘go live’ of FirstDoc 6.4, CYA Hot Backup and Smart Recovery were deployed to provide a robust backup/restore solution of content and metadata. These tools will be used to restore individual Documentum objects as well as support Disaster Recovery efforts.

2012 FirstDoc 4.2.1 6.2.1 Upgrade – This project was completed in two phases: clone and upgrade. Cloning consisted of moving a copy of the database as well as content onto a separate UNIX server. The benefits of ‘cloning’ were 2-fold: (1) allowed IT to retire older server hardware, and (2) move the system onto a less expensive operating system (i.e. Linux). After the cloning process, Oracle, Documentum and FirstDoc were upgraded and tested under IQ, OQ and PQ testing. Additionally, Full-text Indexing was added to the overall system, to expand user search capabilities.

2011 Global Submit Upgrade – The Global Submit environment was upgraded from v4.0 to v6.2.1 (the same version used by the FDA). Dramatic changes to the infrastructure include: (1) converting the Validate application from a fat client to a web-based client, and (2) deploy a SQL database to save all submission metadata.

2010 Risk Evaluation and Mitigation Strategy (REMS) – A top-rated project that was a company-wide, mission-critical endeavor. Delivered several validated web sites for 2 major products, meeting FDA requirements

RADocs FirstDoc 4.2.1 Migration – Migrated content associated with 29 different products from an older Oracle-base repository into FirstDoc. The project was completed via 11 Change Controls.

2009 Global Submit 4.0 – Deployed Global Submit validation toolset to test and verify the integrity of eCTD submissions for two major NDAs before submitting to the FDA.

FDA ESG Gateway – Deployed a dedicated Citrix server for direct access to the FDA Electronic Submission Gateway (WebTrader) ensuring an uninterrupted transfer of content.

ISI Tools Upgrade – Upgrade of in-house ISI publishing tools (e.g. eCTDXpress, ISI Publisher, Virtual Link Manager) via several Change Controls.

2008 FirstDoc 1.2 FirstDoc 4.2.1 Migration – Migrated over 900,000 documents from legacy EDMS system to FirstDoc for R&D (deployed in 2007) in a controlled and validated manner. Scope of migration consisted of moving content to a new FirstDoc Content Server, including source documents, all versions, renditions, and annotations. Also reclassifying document metadata based upon attribute mappings between the two systems, as well as conforming to an eCTD-friendly folder structure.

2007 FirstDoc 4.2.1 – Implemented the latest version of FirstDoc for Research & Development. Project scope included a Development, QA Test and Production environments. Each environment consisted of a Content Server, Full-Text Indexing, PDF Rendering, Watermarking, eSignature and Annotations. The project was completed in compliance with current SDLC methodology and validation practices.

Contact this candidate