SUMMARY

• Technology & regulatory affairs focused goal - oriented professional with solid; Validation including Computer System Validation (CSV), Quality Assurance (QA), Quality Operation, Process Control System, Project Management & Managerial experience.
• Sixteen years of experience in a Biopharmaceutical/ Bio-therapeutics/Pharmaceutical industry including managing QA validation teams, writing / executing validation protocols.
• Expert technical knowledge of analytical & manufacturing technologies for CSV with diverse compliance background in cGxP along with interpreting & implementing FDA procedures & practices including identify errors & developing corrective & preventive action plans.
• A team player working effectively in accomplishing objectives with members of cross-functional, multicultural, diverse, international teams & senior management of matrix organizations. Highly organized with ability to manage project teams & meet deadlines.
• Strong work ethic combined with commitment to excellence in all projects undertaken. Experience working in global QA Validation department of a major pharmaceutical company supported over 15 sites in Americas, Asia & Europe; developed/implemented CSV standards/guidelines (Change Management, SDLC for computer systems, Control Systems Qualification etc) used across sites globally & technical training rollout on these standards.
• Derived/shared CSV best practices associated with automation/control/IT systems across sites. Worked with site staff to prepare budgets, schedules, business cases for large & complex CSV projects, representing CSV in review board meetings, addressed compliance issues pertaining to Consent Decree & supervise remediation teams, supported Quality & Regulatory organizations inspections i.e. FDA Pre-Approval Inspection (PAI), performed vendor & internal audits.

TECHNICAL SKILLS

• Access, Excel, PowerPoint, Project, Word, Visio & Outlook
• AutoCAD
• 7i & MP2 ♦IBM (MRO);
• Procal
• Ladder Logic, Matlab
• Servers & Workstations ♦Cisco; Routers & Switches
• Delta V SIMATIC PCS 7, APACS & APS ♦Wonderware; ArchestrA, IAS, InBatch & InTouch
• Allen-Bradley; RS-Logix & RS-View iBatch, iFIX & iHistorian

PROFESSIONAL EXPERIENCE

Confidential

ASV (Automation System Validation) Team Lead

Responsibilities:

• Developed the control system validation plan, identified the System Development Life Cycle (SDLC) deliverables & provided input on commissioning & qualification testing deliverables. Developed the process flow diagram for the integrated leveraged Equipment Validation & Control System Validation strategy, with input from the project team. Led the effort to ensure that the strategy & plan is approved.
• Developed Project Change Control & Configuration Management Plan for NFF project, including commissioning discrepancy report & change control form. Scope of plan covers Change Control & Configuration activities for equipment & automation systems along with documentation during Commissioning & Qualification phases for all NFF GxP systems. Got various project leads (Process Eng, Utilities Eng, PCS Eng, Plant Eng, System Owner, Validation, Quality & Document Control) along with management buy in on the new strategy at the site. Developed training curriculum & provided training to project team to have clear understanding on Project Change Control process, 80+ resources. leading & directing the validation resources. Responsible for the Computer Validation project schedule. Communicate to project management any issues & concerns regarding schedule.
• Supporting Commissioning & Qualification effort for Control Systems & Equipment for various NFF systems (DeltaV Control Panels & Network, Cooling Tower, Centrifuge, Fraction Vessels, CIP skids, Buffer prep & hold etc.), in different roles including; writing, pre-execution approval, execution, data review, post-execution approval of various documents including; FAT, SAT, RV, IV, CTOP, FV, OV, IQ, OQ, CIOQ, CEOQ etc. Also developing or approving the GxP assessments, risk assessments & change control forms for various systems.
• Provided review & identified areas of improvement on site procedures related to CSV to bring them in line with GAMP5. Presented finding & advantages of risk based approach to stake holders. Initiated effort to ensure common understanding on terms/definitions used in site SOP’s related to CSV.

Confidential, Summit, NJ

Technical / Validation Manager

Responsibilities:

• In-depth understanding of corporate CSV standards/policies/procedures & System Development Life Cycle (SDLC) for computer / automated / IT systems. Part of team that developed these standards & provided training to sites. Lead effort on technical training rollout & implementing these validation standards & procedures across sites to provide consistent & improved CSV executions. Drove & shared CSV expertise/best practices associated with automation, control & IT systems across sites. Acted as mentor for junior members of staff & provided coaching/guidance on company policy & regulatory compliance issues/requirements.
• Manage implementation of strategic computer systems validation in accordance with company & regulatory requirements. Managed Validation IT, Manufacturing & Automation project teams to provide consistent & improved computer validation best practices across sites including; Building Management System (BMS), High Sheer Granulator, Global Computerized Maintenance/Calibration Management System & Enterprise Quality Management System (QMS). Ensured implementation of new Global CSV standards in these projects. Actively & independently steered project teams to meet company standards & government regulations. Duties included development of project plans, business cases for CSV projects, participate in presentations to Site & Global Management. Other duties included interviewing/managing consultants, resource allocation, prioritization of tasks & project scheduling & budgeting, prepare monthly in-depth project status reports, risk assessments, schedule & achievements along with development of validation strategy, review / approval of various SDLC documents. Successfully competed projects on time & under budget.
• Supported Global implementation of PAT solution in Porto Rico & Ireland. Focused on Instrumentation & Process Control Integration with PAT solutions. Responsibilities included; review PAT Data Network URS for Rathdrum, helped site lay out Data Communications Infrastructure for PAT. Provided input on proposal from vendors. Successfully arranged workshop on SiPAT at Singapore site with key site stakeholders & functional heads with no cost to SP. Workshop achieved its goals including, real time data collection from multiple analyzers & OPC server.
• For CSV Legacy Program. Responsibilities included project cost review, providing monthly reports on site project budgets to management & Global Finance, work with site staff to prepare budgets & schedules, perform onsite audit to ensure completion of Periodic Compliance Review activities at various sites i.e. Shiga-Japan, Singapore. Worked / negotiated with site to come up with Corrective & Preventive Action (CAPA) Plan to address observations.
• Represented CSV in weekly Global & divisional Validation Review Board meetings for IT & manufacturing systems. Performed CSV impact assessments on various IT change requests, review/approve IT-Infrastructure change requests i.e. corporate mainframe move. Successfully presented various CSV strategies & Validation Master Plans for various sites to the Global Validation Review Boards for approval.
• Conducted on-site vendor audits. Prepared vendor evaluation & audit reports. Followed up with the vendors on corrective & preventive action plans to address the audit findings. Point of contact with the SP sites providing results of audits for various vendors supporting the IT, Manufacturing & Automated Systems.

Confidential

Computer System Validation (CSV) Engineer

Responsibilities:

• Provided hands-on support on various CSV IT/Manufacturing/Automation/Controls/PCS Systems including; High Sheer Process Granulator, Fluid Bed Dryer, Tablet Pressing/Coating, CIP, COP, AHU, LIMS, TrackWise, CMMS, CCMS. Responsibilities included; layout of CSV strategy, development / review / approval / execution of various System Development Life Cycle (SDLC) documents/plans/procedures/ specifications & testing deliverables including; Master Validation Plan (MVP), Remediation Plan (RP), Computer System Validation Plan (CSVP), User Requirement Specification (URS), Function Requirement Specification (FRS), Development Test Plan (DTP), Software Test Plan (STP), Configuration Management Plan (CMP), Data Migration Plan (DMP), Software Design Description (SDD), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Validation Summary Report (VSR) etc.
• Provided support to the sites in understanding key terms as; audit trail, biometric/non-biometric signature, durable storage media, e-records/signature, hybrid system, meta data, Open/Close System, predicate rules. Review/update Site Master Validation Plans for various sites to give concurrence to Global Validation Review Board for approval. Conducted Part 11 Assessment of various IT-Manufacturing systems (ProCal, Blue Mountain, Honeywell), Gap Analysis & Remediation Plans on legacy systems.
• Member of PAI readiness review team. Participated in inspection process as a respondent to CSV inquiries. Performed various gap analysis on manufacturing & global IT systems. Wrote addendum to fill system security, backup, recovery gaps, resulting in successful approval of PAI.

Confidential

Automation/Project Engineer

Responsibilities:

• Project engineer on site, at Wyeth-Ayerst’s (Amgen) biotech manufacturing facility in Greenwich, RI. Duties included on site design, system debug. Additional responsibilities include assistance with; SAT, startup of control system, development of IQ/OQ/PQ protocols for validation team & operator support in writing & executing various user SOPs.
• Project engineer at Siemens-Moore Springhouse, PA. Project involved design of automation system for Wyeth-Ayerst’s biotech manufacturing facility in Greenwich, RI. Automation system comprised of 30+ Moore Products Company APACS redundant controllers, UNIX based SCADA with 30+ HMI X-terminals, 8000+ I/O & several workstations. Responsibilities included development of Software Design Specification (SDS), design of APACS software for various units & phases, graphic design for various HMI screens & testing of hardware components & I/O for FAT.
• Worked on Siemens-Moore APACS Process Suite for Inspec S-Methoprene project. System used InBatch as batch manager & InTouch as HMI. Developed process model using Visio & recipes using InBatch following S88 standards.