Technical Writer Project

ELBA NIKKI MARTINEZ

TECHNICAL

SUMMARY:

Over *0+ years of diverse experience in Validation and Quality Assurance experience in Bio therapeutic and Pharmaceutical environments.

Excellent experience as a Technical Writer with strict adherence to FDA regulations.

Proficient with EPS (Error Prevention System). Technical writing expertise in writing, reviewing and revising Standard Operating Procedures.

Proficient with use of SAP and TrackWise software.

Highly accomplished professional in the Pharmaceutical/Biotech industries, specializing in Commissioning/Qualification, Validation, Compliance and Remediation, Consent Decree Remediation expertise of industry Utilities and equipment project skills.

Can operate anywhere in the world and with many different cultures of people

Project Management:

Team Management, Schedule Development, Project Plan Execution

Validation & Commissioning:

Over 10 years of direct Validation and Commissioning experience with Utilities, equipment and Process and all associated documentation

Compliance:

Remediation, Investigations, Batch Record Review, Manufacturing Facility Quality

Work Experience:

Provide commissioning and validation support to various companies by assisting in the development and monitoring systems related to FDA GMPs

Knowledge in the area of Utilities, WFI, Nitrogen, Compressed air, USP, steam sterilization for FDA, BI Testing and Steam Quality Testing

Consent Decree Remediation support

Prepare/review the following System Development Life Cycle (SDLC) documentation:

IQ/OQ/PQ/Protocols & Summary Reports

Know Coordination, execution and competitions in Autoclaves, temperature mapping and BI Testing

Coordination, execution and competition of all aspects of Kaye temperature mapping validation projects

Mentor, and provide Validation & Commissioning guidance to other validation/compliance staff members

Perform assessments of procedures, utilities and other manufacturing equipment for compliance to cGMP, site guidelines

All phases of Utility an installation, and qualification verification

Interface with the Client and Process Owners to develop Commissioning and Validation project schedules/strategies

Review documents for accuracy, completeness, consistency, and adherence to site procedures

Review/revise/update Standard Operating Procedures (SOP’s) with Error Prevention.

Implemented and reviewed change control requests and work orders related to utilities and equipment

Participated on teams for Manufacturing Investigation Reports

Administrator and Super User for the Kaye Validator 2000 and ValProbe Systems

Analyzing qualification results, determining acceptability, and generating and resolving protocol discrepancies

Diverse in the interaction with different people and departments (Engineers, Mechanics, IT, Operators and Quality)

3/17-Present Lonza Viral-Base Therapeutics-Houston, TX

Technical Writer- Operations Shared Services

Responsibilities:

Provide oversite over EPS (Error Prevention System) Report to the Site Head of Shared Services.

Responsible for designing documents for EPS formatting all current SOPs (Standard Operation Procedures) for Facilities, Engineering, Manufacturing, Quality Control and Quality Assurance to new Error Prevention

Authored Department SOPs for new Commercial and Clinical facility.

Provided oversite of Material Management of Part Numbers to transition to preferred Vendor.

01/16 – 08/16 Fujifilm Diosynth Biotechnologies - College Station, TX

Contract Validation and Regulatory Compliance Engineer

Pandemic Influenza Facility (PIF) and Live Vaccine and Virus Facility(LVVF)

Responsibilities:

Review of site utilities User Requirement Specifications and Engineering Turnover packages to ensure compliance with federal regulations. Once compliance is established, creation of system specifications for utilities.

Created punch lists to address compliance issues and GMP documentation and worked with subcontractors to address issues

Author of system specifications for site utility systems. Examples of system specifications such as Reverse Osmosis Deionized Water (RODI) Generation and Distribution as well as Heating Ventilation Air Conditioning (HVAC).

Coordinated with site building contractors to resolve discrepancies regarding site compliance and engineering issues.

Led client based directives to determine at fault analysis of engineering discrepancies in order for the client to prove liability to building contractors.

10/11 – 11/12 Teva Animal Health, St. Joseph, MO

Consent Decree Consultant

Responsibilities:

Implement a compliant, sustainable Fill Line Validation Quality System.

Align site with corporate key points of compliance for process validation.

Address gaps found during the inspection for validation.

Working with Consent Decree (CD) teams to get process and procedures to comply with industry standards and guidance.

1/11 – 5/11 Boehringer-Ingelheim, St, Joseph, MO

Commissioning & Qualification Consultant

Responsibilities:

Executed the integrated commissioning protocol for Inactivation Tanks.

Performed (CIP) Clean in Place and (SIP) Steam in Place testing from HMI on both tanks and CIP skids.

Authored final reports, IOQ Protocols.

7/10 – 11/10 Boehringer-Ingelheim, Cleveland, OH

Commissioning and Qualification –Lead

Responsibilities:

Lead the commissioning and IOQ phase on the Bosch filler.

Authored IOQ, Cycle development procedure and Final Reports.

Conducted assessments of client studies, procedures to determine compliance.

1/10 – 6/10 Medimmune, Federick, MD

Commissioning & Qualification

Responsibilities:

Assisted QC in Testing EM studies.

Interpreted and Documented Test Results for Cleaning Validation processes on bioreactors.

Author final PQ-Reports, Engineering Studies and Data analysis on Cleaning Validation protocols.

Performed thermal mapping on warehouse with K-Validator.

7/09 – 1/10 Abraxis BioScience, Phoenix, AZ

Commissioning & Qualification

Responsibilities:

Primarily responsible for writing Commissioning and Validation deliverables; also Executed and assisted in overall validation tracking and ensured validation project timelines were met.

Execute Integrated Commissioning and Qualification Protocols for HVAC System, WFI, Pure Steam, CIP, Nitrogen and Compressed Air and Bosch process equipment. Validation for projects throughout; including validation plans, requirements specifications, P&ID’s, checklists and validation reports

Work with system experts to determine and capture appropriate requirements specifications.

Tracked in-progress validation projects and ensured established timelines were met.

7/08 – 4/09 Opti Medical, Roswell, GA

Commissioning & Qualification

Responsibilities:

Supported company in wide validation efforts to update device technical documentation and Validation in support of conformance to essential requirements and compliance to all applicable standards (i.e. EN, ISO, ANSI, ASTM, etc.).

Generated IOQ protocols and reports to demonstrate products met defined requirements.

Audited Design Verification reports (including work orders, training records, and analyzed data), Market Specifications.

Ensured product specifications accurately described the product and updated with applicable standards.

Performed Design Verification testing on specific devices with respect to all relevant attributes (i.e. materials, processing).

2/07 – 6/08 Cephalon, Salt Lake City, UT

Commissioning & Qualification

Responsibilities:

Responsible for validating a relocated DEA Vault, tested for temperature and humidity requirements.

Responsible for reviewing, auditing Commissioning and Validation of facility's validated/ non-validated equipment and systems ETOPs, from commissioning verification through validation, and client acceptance.

Commissioning & Qualification (3/06 – 6/06)

Responsibilities:

Define Commissioning and validation requirements, process system documentation critical and non-critical Systems.

PFC, FC, IO/OQ, PQ ETOP/Protocol execution.

Responsible for defining validation requirements, process systems documentation, executed test protocols and generating Validation Summary Reports.

IQ, OQ protocol generation and execution in an Ophthalmic and Parenteral manufacturing environment.

Equipment including, Girton Parts Washer, McBrady Exterior Vial Washer and the Mengibar 1150.

Commissioning & Qualification Ft. Dodge, IA (9/06 – 2/07)

Responsibilities:

Define validation requirements for newly constructed GMP warehouse.

HVAC system, BMS, Raw Material storage, Walk in Coolers, Walk in Freezers, QA Raw Material Sampling room.

Review & comment on drafts of Client generated IQ / OQ / RQ / EQ Protocols.

Generated, Compile and Execute System Validation Test Packages in accordance with Project validation master Plan including System P&ID walk down / redline equipment drawings and monitor system start-up.

Execute test Protocols, generate deviation reports, errata sheets and punch list documentation.

Coordinate with client and construction management on observations, and issues that may impact compliance testing.

6/06 – 9/06 Pfizer, Ann Arbor, MI

Validation Department/Lead

Responsibilities:

Lead process system documentation for Animal Vivarium.

Commissioned, PFC, FC ETOP generation and execution in several systems: Cage washer, Animal Drinking water, Fire Alarm, Smoke Detection security, Water waste, water, chillers, Power, Nitrogen gas, and HVAC system.

Coordinated testing with all contract Vendors while attending daily meetings with client to discuss timeline, issues and project updates.

Generated daily punch list reports and final Summary Reports.

2/05 – 10/05 Cardinal Health, Albuquerque, NM

Validation Department/Lead

Responsibilities:

Responsible for leading team for Commissioning/Validation activities and the execution of project and equipment qualifications of manufacturing systems, equipment and processes in an aseptic manufacturing facility.

Generated/executed/reviewed IQ, OQ protocols, reports and SOPs.

Provided guidance and training in the execution of validation related activities.

Equipment commissioned and validated included: IOCS Stopper Washer, Sterilizing Machine and Fedegari Autoclave.

Audited/assured all validation activities were performed in compliance with approved protocols, facility SOPs and applicable standards/regulations/guidelines.

Maintained, compiled and analyzed data associated with the execution of validation/qualification related activities and generated final reports.

Knowledge in temperature mapping with Kaye 2000 Validator.

6/04-11/04 Neorx, Denton, TX

Validation Department

Responsibilities:

Responsible for defining validation requirements, executing test protocols and generating Validation Summary Reports.

Knowledge in generation and execution of IOQ protocols.

Systems/Equipment included Critical Utilities: Purified Water, Clean Steam, WFI, Compressed Air and Nitrogen Systems, Environmental Monitoring.

Data compilation for commissioning and Validation studies: manuals, P&ID drawings (redlining), schematics, user/functional requirements and Change Control systems.

EDUCATION:

Western Michigan University, Kalamazoo, MI

BA Sociology

TRAINING:

cGMP

Aseptic Process

Radiochemistry Safety

cGCP and ICH currently training

CRA (Clinical Research Associate) Certification- Currently Training

U.S Military Army

Electrical Network Switching Systems Operator

Contact Information:

Cellphone Number: 616-***-****

Email: **********@*****.***

Contact this candidate