John Niziolek Email & Phone Number

Philadelphia, Pa, Us

Blue Bell, Pa, Us

Responsible for the development and growth of the Computer Systems Validation (CSV) / CSA & Data Integrity (DI) and Medical Gas Practices at IPS.Key areas of focus include :- Delivery of services in accordance with Industry Best Practice- Development of new client services and solutions- CSV / Data Integrity Subject Matter Expert (SME)- Business Development- Building the IPS CSV/CSA & DI, and Medical Gases brands- Promoting & Insuring a positive client engagement- Growth and Expansion of the IPS CSV/CSA & DI, and Medical Gases teams

East Greenville, Pennsylvania, Us

Role / Responsibilities• Successfully implemented new global ERP platform resulting in savings for 20+ million across all business organizations• Managing a team of highly technical resources in support of multi-platform data related activities• Acting as a technical liaison between IT and the business• Ensuring the overall integrity and health of all Product Data• Primary point of contact for all Product Data related activities and issues• Lead data focused initiatives in support of the business• Development and Implementation of process optimization practicesKey Accomplishments• Successfully implemented new global ERP platform resulting in savings for 20+ million across all business organizations.• Established new standards for governance and policy ensuring integrity of corporate data systems.

Santa Monica, Ca, Us

Role / Responsibilities• Own and drive regulated business vertical ensuring the needs of the business and client have been achieved• Developed, hired, lead, and trained International team of compliance consultants • Being a thought leader on regulatory compliance• Continually keeping in touch with industry best practice and utilizing knowledge to develop and maintain the corporate point of view• Resource planning / pricing• Developing compliance offerings to generate revenue streams new to the company• Managing, facilitating, and performing discovery audits on behalf of clients and industry regulatory authorities• Development of internal support processes, tools, and systems for the partner community• Supporting sales with consultative advice for prospects• Serving as liaison between Quality and Product StrategyKey Accomplishments• Assisted in delivering the highest total value contracts in company history • Grew regulated industry business from 125,000 users to 5+ million (40X growth rate)• Grew vertical revenue FY13= 210% FY14=173% FY16= 185% (YoY)• Implemented overarching corporate Quality Management System (QMS) • Developed industry differentiating services propelling company to top compliance platform with a win at a rate of 80%+ in the regulated space.

Role / Responsibilities• Ran successful specialized technology consulting business focused on industry specific technology and regulatory solutions.• Hired, lead, trained consultants (as needed) to support client and business need• Contract negotiation and vendor liaison• Best practices review and application• Manage complex client relationships ensuring all aspects of their needs are met and addressed as agreed upon• Technical liaison to the business / management• Manage and maintain budgets related to the technology aspect of the business• Six Sigma process consultation and implementation• Regulatory compliance specialized services focused on ISO,SOX, Milspec, CFR, EU, and various other industry standardsKey Accomplishments• Many fortune 100 / 500 clients such as Johnson & Johnson, Sanofi, and GlaxoSmithKline• Maintained consistent business pipeline for the life of the company without lapse or gap in contract periods• Managed consent decree oversight process for McNeil (J&J) in the microbiological and analytical laboratory areas.

Us

Commissioning & Qualification Lead, Laboratory Restart - Consent DecreeResponsible for commissioning and qualification of the laboratory equipment tied to the McNeilManufacturing Project for the facility which is in Consent Decree.• CSV Assessments• Electronic Record and Signature Assessments (21 CFR Part 11)• Development, Review and Execution of : URS,STP, IQOQ, SOP, Work Instructions, Val Plans, PQP, PQ, PT, & other compliance related items / Memos. Protocols, Summary Reports,• Validation Reports and Requirement Traceability Matrices.• Best practices review / implementation• Sterilization Validation• Laboratory and Bench top Equipment Validation• CTU Temperature Mapping (w/Kaye)

Paris, France, Fr

Responsible for cycle development and performance qualification of the Fedegari cGMP autoclave and the SIP of the vent filters.• Programming and development of cycles for the Fedegari cGMP autoclave Thema4 controller• Development of load patterns for use in the cGMP Fedegari autoclave• Development of protocols and reports• Review of executed test documentation for adherence to site procedures and GMP related guidelines in order to meet EN 285 criteria, as well assite and global sterility acceptance criteria.• Providing training on the operation of the autoclave and the validated load patterns.

Complete remediation of legacy systems (Category 1–5) including: • LIMS support• System Register Database management• Derived values Excel Spreadsheet Validation• Action Plan Assessment and Corrective Action close out• CSV Assessments, Electronic Record and Signature Assessments (21 CFR Part 11) • Development, Review and Execution of IQ/OQ/PQ Protocols, Summary Reports, Validation Reports and Requirement Traceability Matrices. • Computer Automation Systems, DeltaV documentation, validation and commissioning. • Building Automation Systems, Siemens Apogee documentation, validation and commissioning.• Equipment Validation - FIT Analyzers, BIO Welders & Sealers, Autoclaves, Ventilation Hoods, YSI Analyzers, Spectrophotometers, On-line TOC analyzers, HPLC, various others.• Computer Systems - Architecture Analysis, Database validation and commissioning, • User Requirements gathering and specifications writing.• Shipping Validation Studies, Temperature Mapping, Development Studies

Valley Forge, Pa, Us

Role / Responsibilities• Planning / coordinating / implementing medium and large-scale IT projects to meet business goals and objectives• Team Technical Adviser - responsible for managing and mentoring a team of 15 technical members which oversee and maintain the corporate Web presence (2 million + registered users).• Architecture review / design review of new code / existing projects to determine technical feasibility• Experience with design and carrying through life cycle to operational reality complex system architectures, comprising multiple components across heterogeneous server and network infrastructures, typically multi-vendor systems, for large-scale user bases and varied processing profiles • Best practices review / implementation• Planning and coordination of complex multi-tiered projects. • Standards development / implementation. • Technical consultation to the business. • Six Sigma projects / Process improvement

London, Gb

Responsible for the support of the 800 user based computing environment.• Capacity planning for the enterprise• Upgrade assessment / feasibility• DOD Audit POC• Monitoring and maintaining UNIX server environment• Daily support tasksAdditional InformationSecret Security Clearance (Inactive)

Computer Science

Drafting & Design Technology

College Prep