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Lead Senior Validation Engineer Resume

Morristown New, JerseY

SUMMARY

  • A Hands on professional with extensive managerial and technical experience in the area of pharmaceutical computer system validation and technology areas; with an emphasis in project management, system administration, documentation and quality and validation assurance.
  • Experienced as a Pharmaceutical Business Analyst, having collaborated with IT teams (Client, CRO), subject matter experts, and stakeholder scientific groups to understand, gather, and validate formal business requirements, use cases and process flows requirements. Also identify and utilize the proper compliance reporting to stakeholders to maintain a proper project flow. Act as the liaison between the business organizations, the technical areas, and maintain an open flow of communication.
  • Recognized for excellence and exceptional abilities with progressive, challenging assignments in ascertaining client needs, delivery of solutions, deliverables and support in a SDLC environment.
  • Accustomed to a corporate environment with 18 years of pharmaceutical experience operating in a consent decree environment, direct interface with the FDA, Foreign Health Authorities and 3rd party agencies, accustomed to working with offshore colleagues, and globally located utilizing a risk based quality assurance approach for compliance.
  • Thorough global and domestic understanding of pharmaceutical compliances, (Annex 11) regulatory requirements and internal pharmaceutical procedures in manufacturing, laboratory and quality assurance areas.
  • An in depth exposure and experience with QA GxP inspections, report audits, internal and external evaluations, validation, assessments of compliance, regulations dealing with difficult technical issues, and data reviews (GAPS) that support company developmental and in production projects.
  • Experience in using IT systems in a GMP environment.
  • System Development Life Cycle (SDLC) methodologies
  • At least 10 years of prior experience working in an analyst capacity on large and/or complex projects in the Pharmaceutical Industry
  • Experience in an analyst capacity on a large scale COTS project, a custom development project, and/or combination of both (impacting 100+ Users across multiple domains)
  • Experience with formal SDLC practices, emphasis on Analysis & Design stages, Agile methodology
  • Proven ability in gathering, tracing, translating and managing complex requirements, business rules, and data
  • Exceptional interpersonal skills; able to communicate effectively with both technical and non - technical teams; able to provide technical leadership
  • Outgoing personality; self-starter able to work interactively and independently with stakeholders
  • Possess strong business acumen; possess a broad, enterprise-wide view and understanding of strategy, processes and capabilities, enabling technologies, and governance
  • Good understanding of Change Management, conduct Change advisory board meetings
  • Experience in the preparation, issuance of reviews of inspected and audited projects. An effective communicator to professional staff and leadership across all departments in the delivery and response to inspections, and audit findings, Assist and facilitate in regulatory agency inspections, project team meetings, and training activities.
  • Having extensive experience in the areas of 21 CFR Part 11 (Electronic Records/Signatures), Parts 210/211 (Drug Good Manufacturing Practices, 820 (Medical Device/Quality System regulation), Part 58 (Good Laboratory Practices), GAMP5 and knowledge of SOPs and documentation requirements in the pharmaceutical industry.
  • Extensive experience in all GxP environments, research, global supply chain and laboratory e.g. Labware, Watson LIMS and manufacturing areas. Have effective communication, presentation and negotiation skills.
  • My strengths are in excellent communication, problem solving, prior training and computer network experience, and a good proficiency with Microsoft Office Products, Parexel (Liquent) Products (Regulatory Submissions), Remedy, Trackwise, Jira, Documentum, Oracle, SAS, SAP, HPALM, and others. It is my goal to attain a position that utilizes my aforementioned experiences, strengths and skill sets as well as use the opportunity to share these strengths and skills to others, and to learn new skills and opportunities through team building and interaction.

PROFESSIONAL EXPERIENCE:

Confidential, Morristown, New Jersey

Lead Senior Validation Engineer

Responsibilities:

  • Performed Gap-Analysis on current process equipment IQ/OQ/PQ status (GLP, GMP).
  • Wrote IQ/OQ/PQ Protocols and authoring and reviewing various types of Summary Reports.
  • Utilized knowledge of GMP and EU regulations including 21 CFR Part 11
  • Reviewed equipment and process schematics.
  • Provided Validation deliverables utilizing Confidential ’s ‘QDoc Repository System’ (Documentum)
  • Utilized HPSM, Oracle support ticketing system
  • Provided full Validation and Quality support for Oracle’s LSH (Life Sciences Hub), Rave (Medidata) applications (ODM, Adapters), JReview, Impact, and other Confidential internal applications within a Clinical Trial Environment.
  • Managed and performed Change Management processes as required
  • Provided Validation and Quality support, authoring and reviewing for Oracle LSH Migration and Upgrade project activities (Validation Plan, User Requirements, Functional Specifications, Mappings, Testing, Gap Analysis, etc. (all system development life cycle deliverables)).
  • Performed validation activities related to Oncology trials for EDC based studies.
  • Prepared specification documents, Plans, Test Scripts, Summary Reports
  • Conducted Tester Training and coordinate testing effort
  • Managed study specific validation documents within Data Management area
  • Ensured all the validation deliverables were completed within established project timeline
  • Ensured all the tools and programs were developed using standard SDLC methodologies and established standards
  • Performed risk assessments
  • Ensured all validation activities and processes performed were conducted according to standard operating procedures and GCP and GMP
  • Maintained Data Governance, Data Integrity, and Data Quality Oversight

Confidential, Bridgewater, New Jersey

Lead Senior Quality Analyst, Audit Leader, Trainer

Responsibilities:

  • Supported IS Quality role on global and domestic IS projects and applications.
  • Provided project support that included guiding validation and testing strategy, reviewed and approved key project documents (e.g. validation plan, requirements, design, testing, reports)
  • Application support that included guiding change controls including impact assessments, change plans and test plans. Reviewed and approved change controls and implementation documentation against previously approved change plans.
  • Provided Compliancy (Quality/Validation) direction and support for all aspects (upgrades, new applications, patches to software and maintenance activities of Sanofi’s Regulatory Computerized Document Submissions Systems. Parexel/Liquent and EMC's Documentum D2, and Systems that interfaced with SAP environments.
  • Support other IS Quality activities as requested (e.g. periodic review, Part 11 compliance, audits, training, leading Computerized System Functional Risk Assessments, Assessing Data Privacy concerns, Assessing Computer System Criticalities)
  • Skills: Computer Validation, Change Management, System Development Life Cycle, GAP Analysis, Risk Analysis, Training Skills, Authoring of various Documentations
  • Lead preparation activities for Internal Audits of Computerized Systems within the R&D IS space, and also performed required training for audit participants involved in audit presentations. Authored Audit presentation slide decks, and documentation
  • Managed R&D IS Audit findings and CAPA responses, and set timelines for proper responses, completions, close outs of audit finding responses and CAPAs in a timely manner
  • Trained and used Remedy, HP Quality Central, Parexel Regulatory software suites (Insight for Viewing), Visio, Citrix, Sharepoint, Microsoft Office Suites, Microsoft Project, IRMS, Clintrial, SharePoint, Oracle Identity Management, SailPoint, Blaze LIMS software packages.
  • Provided Quality Review support for several Validation documents and Test executions to address compliance to Quality standards and to expedite approval processes related to SAP system (module) upgrades.
  • Responsible for performing quality assurance activities as it relates to GxP automated and computer systems compliance (utilizing SDLC protocols) within Lilly(Imclone), and meeting regulatory requirements, and all corporate internal procedures
  • Assessed compliances and regulations from a risk based assessment approach.
  • Provided effective communication flow, with professional staff, and leadership across all departments
  • Authored and executed system and user acceptance testing.
  • Provided recommendations for process improvement and assessments to the ongoing development of new installations of 24 Allen Bradley HVAC PLC air handling systems at the Lilly (Imclone) Branchburg, New Jersey Site.
  • Authored and reviewed testing documentation for the replacement of all PLCs that controlled all environment controls within the manufacturing area

Confidential, Summit, New Jersey

Senior Quality Analyst

Responsibilities:

  • Was responsible for performing quality assurance activities as it related to GxP automated and computer systems compliance (utilizing SDLC and VLC protocols) within Confidential, and regulatory requirements, and internal procedures
  • Planned and conducted QA GxP inspections, periodic reviews, report audits, facilitate and performed vendor audits, internal/external evaluations, validation and data reviews that supported the company’s development projects.
  • Assessed compliances with regard to regulations from a risk, regulatory and criticality based assessment approach.
  • Provided research, authored, and assessed Gap Analyses
  • Prepared and issued reviews for each inspected (GxP audited projects and or validated computer systems).
  • Provided effective communications flow, with professional staffs, and business leadership across all departments
  • Assisted in all regulatory agency inspections (both foreign and domestic), project team meetings and training activities.
  • Authored and executed user and system acceptance testing.
  • Authored and reviewed of corporate SOPs (high level and departmental).
  • Provided recommendations for process improvement and contributions to ongoing development of new auditing procedures, techniques and corporate guidelines.
  • Provided reviews and recommendations for all System Development Life Cycle Deliverables
  • Assessed and authored updates to existing System Development Life Cycle documentation as required
  • Supported Regulatory, Laboratory (Clinical), Discovery, Pharmacovigilance (Research & Development), Manufacturing Equipment, Facilities and Laboratory (Production), Animal Health and Global Quality/Compliance areas
  • Yellow Belt Six Sigma trained

Confidential, Summit, New Jersey

Quality Analyst

Responsibilities:

  • Was responsible for performing quality assurance activities as it related to GxP automated and computer systems compliance (utilizing SDLC and VLC protocols) within Confidential Research Institute (SPRI), and regulatory requirements, and internal procedures
  • Planned, facilitated, and conducted QA GxP inspections, report audits, vendor audits, internal/external evaluations, validation and data reviews that supported company development projects.
  • Assessed compliance with regulations from a risk, regulatory and criticality based assessment approach.
  • Prepared and issued reviews for each inspected (audited projects, and or validated computer systems).
  • Provided effective communications flow, with professional staff, and leadership across all departments
  • Assisted in regulatory agency inspections (both foreign and domestic), lead and facilitated project team meetings and training activities.
  • Authored and executed user and system acceptance testing.
  • Authored and the review of corporate SOPs (high and departmental level).
  • Provided recommendations for process improvement, and contributions to ongoing development of new auditing procedures, techniques and corporate guidelines.
  • Provided reviews and recommendations for all System Development Life Cycle Deliverables
  • Assessed and authored updates to existing System Development Life Cycle documentation as required
  • Supported Regulatory, Laboratory (Clinical), Discovery, Pharmacovigilance (Research & Development), Manufacturing Equipment, Facilities and Laboratory (Production), Animal Health and Global Quality/Compliance areas
  • Provided Laboratory support (qualifications, validations, equipment, and instrumentation) for both manufacturing, clinical, and discovery settings
  • Was responsible in providing end user support on a variety of validated computer systems for the Confidential Quality Documentation and Quality Labs Community (both hardware and software support)
  • Authored all computer system change requests, and executed System and User Acceptance Testing
  • Authored all required corporate system SOPs to meet all compliances
  • Provided and authored all validated computer system user guide documentation, as well as system administration documentation
  • Participated, facilitated, and interfaced with the FDA and Foreign regulatory inspections that audited the administration, operation, training, user access, and demonstrated that all validated computer systems inspected were found in a compliant state with no adverse observations, and findings
  • Project managed major new implementations and upgrades on time and within budget
  • Provided help desk resources for all validated computer systems for the end user utilizing the Remedy software application as the change management tool.
  • Managed all validated computer systems utilizing the Trackwise application for the management of all CAPAs
  • Subcontracted and provided consultation services in the areas of performance qualification, installation procedures, operation, and qualification protocols. Specifically in the areas of testing and verification of proposed software applications for pharmaceutical field sales representatives that provided their ability to manage their allotted and tracked drug inventories. Also, for the purpose of meeting requirements as required by the FDA, resulting in compliance.
  • Supported the IT and Marketing areas

Confidential, Princeton, NJ

Systems Analyst

Responsibilities:

  • Consulted with marketing to deliver complete solutions and project managed the delivery of solutions (hardware and software) on time and on budget with specific emphasis to the pharmaceutical industry.
  • Lead design team that provided as well as developed technical and marketing support programs for clients.
  • Worked closely with regional account managers in the development and the execution of sales and service strategies.
  • Conducted customized product demonstrations and presentations for pharmaceutical audience levels: Executive, End User, and Technical specifying CFR21 Part 11 compliances.
  • Identified opportunities for revenue growth by evaluating customer base characteristics.
  • Served as an internal and external consultant for pharmaceuticals on issues such as applications, hardware, integration, and technology plans.
  • Consulted with several top pharmaceutical companies in identifying operational opportunities as it related to 21 CFR Part 11 requirements. Provided Xerox based printing, archiving, retrieval, image manipulation, merging and scanning solutions that provided compliance.
  • Consulted and delivered solutions to the pharmaceutical industry that provided as a transition path from hardcopy documents to electronic document submissions to the Federal Drug Administration. Specifically as to the submission of electronic document submission for the purpose of New Drug Applications (NDA) and the archival and availability of documents as needed by the FDA and the client.
  • Participated in and managed the delivery of selected applications, chosen hardware, and design integration.
  • Conducted facilitating sessions to identify requirements for pharmaceuticals in the areas of applications, work flow, and project management.
  • Delivered seminars and training curriculum to clients upon delivery of proposed solutions.
  • Designed and managed customer services and support
  • Managed a staff of 25 members in personal computers, and client/server support.
  • Developed the process to maintain and upgrade all hardware and software to meet Y2K compliance.
  • Managed and delivered curriculum to aid end users of Y2K differences in hardware and software applications.
  • Managed and performed Computer Validations to ensure proper platform and application Y2K compliance.
  • Successfully provided support to the pharmaceutical industry in ensuring Y2K compliance and FDA compliance. The project was completed on time and within budget, with zero adverse results for clients.
  • Successfully created and worked with a group that started network services within the Confidential local branch office located at Princeton NJ; that netted $4 million in its first year and $7.5 million in its second year in additional revenues.
  • Coordinated and integrated functional group plans into an overall planning.
  • Was the prime customer interface for project delivery work within functional groups, sales team, and line of business units in order to ensure on time, quality delivery.
  • Managed project costs, reported on plan statuses, and action plans for the customers.
  • Provided a variety of services internally and externally for the purpose of training, product support, financial analysis, technical/project managerial lead.
  • Participated in the quality assurance testing and created user documentation for all platforms.
  • Volunteered time with local school system and with local church in setting up and maintaining computer network systems.
  • Worked with local church in upgrading computers and recommending applications and establishing networked systems.
  • Project managed local church building addition that dealt with fundraising as well as construction and furnishing with a value of $2.5 million dollars. This was accomplished on time and within budget.

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