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Associate Director Of Validation Resume

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Windsor, CT

SUMMARY:

  • I have extensive project management experience and use of Microsoft Suite and other PM Tools to keep projects on timeline and budget.
  • Successfully performed new product introduction and technology transfer projects with cross functional teams.
  • I am a certified Lean, Six Sigma Black Belt with proficient in data analytics using Minitab, Python.
  • My experience includes capital management, equipment procurement, risk assessment, and process design.
  • My engineering experience includes process development, creation of engineering specifications, process and packaging equipment, utilities, computerized systems, facilities and lab equipment.
  • I am process oriented and an innovative problem solver.
  • Leadership and communication skills to deliver individual and team results.

PROFESSIONAL EXPERIENCE:

Confidential, Windsor, CT

Associate Director of Validation

Responsibilities:

  • Responsible for managing the validation and metrology groups for Confidential manufacturer at two facilities.
  • Supervise, provide direction and assign work to team at both facilities.
  • Conducted system level and functional level Risk Assessments with team to identify gaps.
  • Updated validation strategy to meet current regulatory expectations: validation system, SOPs, and protocol templates, media fill, process validation warehouse mapping, shipping studies, smoke studies, etc..
  • Harmonized approaches and procedures between both facilities.
  • Responsible for the aseptic process validation and media fill programs.

Confidential, Lake Forest, IL

Global Compliance and Audit Manager

Responsibilities:

  • Responsible for qualification program and process improvements to streamline the qualification life cycle.
  • Managed Part 11/ Annex 11 Data Integrity and periodic review programs.
  • Assist in the development of multi - country regulatory strategy based upon regulatory changes.

Confidential, Woodstock, IL

Sr. Project Manager

Responsibilities:

  • New product introduction of ophthalmic, inhalation. device, nutraceutical products.
  • Managed serialization implementation on multiple packaging lines using Optel equipment, Axway Tracksafe, Warehouse Management System, JE Edwards ERP system and client based systems. Conversion of the Number Range Management system to Systech Track and Trace. Developed user requirements, validation,, approved packaging artwork.
  • Design through commercialization of automated production lines for $120M contract.
  • Program Manager for Equipment Revalidation, Periodic Validation Review and Continuing Process Validation.
  • Validation program updates for regulatory requirements for US, EU, ISO, WHO.
  • Developed corporate/site programs for Computer System Validation, Cleaning Validation, Cleaning Revalidation.
  • Managed Computerized System validation lifecycle, Part 11/ Annex 11 data Integrity, gap assessment, and periodic review.
  • Managed product /raw material storage for controlled room temperature and warehouse MKT storage.
  • Presented project proposals, gate reviews, benefits to executive management.
  • Developed and delivered Lean Six Sigma for green belt, kaizen and sponsors.
  • Supported Operational Excellence program at multiple sites.
  • Led numerous kaizen events for quick improvements with cross functional teams.
  • Utilized advanced data analysis techniques, Measurement System Analysis and DOE.
  • Production line visual management, line balancing, created more efficient line layouts, created line man maps, created SOJTs, and performed for operators to understand their roles.
  • Managed Overall Equipment Effectiveness (OEE) program.
  • Corporate Team for Working Capital Reduction, Site Harmonization, QC lab efficiency.
  • Drove the CAPA and effectiveness check process to ensure proper root cause analysis, identify opportunities for error proofing and defect reduction/prevention projects.
  • Process improvements to increase product yield ($1M annually), batch release 35% cycle time reduction, Fill Volume control ($450K annually + $750K contract bonus), sterilization processes error reduction ($450K annually).
  • Packaging process improvements for missing component defects / rework reduction project, created visual management systems, line balancing, created line man maps.
  • Created warehouse visual reorder /Kanban /VMI /JIT systems: reduced inventory by $600K, increased inventory velocity and eliminated material handling steps / paperwork ($150K annually).
  • Instituted 5S /Visual Management in labs, production and maintenance for improved schedule adherence.

Confidential, Woodstock, IL

Associate Director of Validation

Responsibilities:

  • Directed validation and regulatory strategy for the Blow/Fill/Seal facilities in Woodstock, IL and Humacao, PR.
  • Quality Assurance director for Albuquerque, NM site during a management transition.
  • Redesigned the validation system and other quality systems.
  • Harmonized approaches between multiple facilities/clients to meet regulatory expectations.
  • Leadership of R&D, clinical, and commercial products for commercial production.
  • Managed validation and process development of technology transfers & new products.
  • Responsible for the aseptic process validation, sterility assurance validation and media fill program.

Confidential, Morton Grove, IL

Regional Validation Project Manager

Responsibilities:

  • Preparation of detailed project schedules, goals, milestones using project management software. Sales and client development, contract negotiation and project budgeting.
  • Device design verification and validation including IV pump and software.
  • Developed Quality Systems (validation, calibration, maintenance, laboratory, change control).
  • Prepared Validation Master Plans, contributed to regulatory strategy, participated in FDA audits/ responses.
  • Developed GLP standards: SOPs,, data entry, method development and lab equipment validation

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