Manufacturing Associate Validation Engineer

SUMMARY OF QUALIFICATIONS

Persistent focused professional with strong technical background focused on bringing high achieving results to a challenging company. Ensures all deliverables meet the quality standards and requirements of company policies and all regulatory regulations Key areas of strength include effective communication, coordination, and time management.

SKILLS

Proficient understanding of 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 11, and GAMP 5

Capable of functioning in a fast-paced team-oriented environment or working individually

Excellent interpersonal, organizational and time management skills with ability to manage multiple tasks

Demonstrated ability to trouble shoot, make decisions, and solve any problems based on experience

High degree of commitment to continuous learning, improvement, and personal development

Demonstrated ability to consistently produce thorough work accurately and with high quality

Experience in delivering training and/or creating training materials required for employee development

EXPERIENCE

March 2020 – Present Yoh Scientific Philadelphia, PA

Validation Specialist Consultant

Consult with companies to provide expertise in the area of C&Q validation

Spark Therapeutics, Philadelphia, PA: Currently supporting C&Q and CSV activities including authoring, executing, and/or reviewing the following: CSV test plans/test summary reports, IQ/OQ/PQ protocols/reports, data migration protocols/reports. Required to author and/or review the following: Requirement Traceability Matrix, URS, Configuration Specifications, Design Specifications, Computer Validation Risk Assessments, SOPs, supplier test plans, and other qualification activities. Responsible for scheduling and coordinating protocol execution, vendor visits, and providing updates to the stakeholders. Assisted with document and/or equipment remediation for Data Integrity inclusion.

November 2019 – January 2020 Kymanox Mooresfield, NC

Process Validation Consultant

Consult with companies to provide expertise in the area of process validation

Pharmedium, Dayton, NJ: Remediation efforts in alignment with the consent decree which included executing process development/validation activities, authoring PPQ protocols, overseeing the protocol execution, document review, scheduling and coordinating protocol executions and sampling activities, and establishing stability limits.

July 2014 - November 2019 RADIANT INC. South Plainfield, NJ

Cleaning Validation Consultant

Consult with companies to provide expertise in the area of cleaning validation

McNeil (subsidiary of Johnson & Johnson), Fort Washington, PA: Remediation efforts at the site in alignment with the consent decree which included authoring and executing CIP, COP, and manual cleaning cycle development/verification/validation protocols, scheduling and coordinating cleaning executions and sampling activities, establishing CCPs and cycle parameters, and authoring summary reports. Performed visual inspection following the equipment cleaning cycle to visually confirm equipment surface area cleanliness. Lead RCAs to assess the impact of any visual observations. Also performed routine monitoring for validated cleaning processes which may include equipment sampling. Cleaning validation executed on Parts Washers, Mix Tanks, Holding Tanks, Bulk Storage Tanks, Packaging Lines, and Valve Matrices. Also responsible for assessing cleaning validation requirements for new equipment or products, authored pre-requisite documents including soil comparability report, estimated surface area calculation report, product grouping report, equipment grouping report, and change controls. Participated or lead root cause investigations for atypical events.

February 2008 - July 2014 GLAXOSMITHLINE King of Prussia, PA

Validation Engineer

Supported cleaning validation activities including protocol development and compliance verification against industry and regulatory standards.

Served as an SME for all cleaning validation related topics.

Provided guidance and help troubleshoot all investigations arising from cleaning validation.

Performed soil assessment studies for cleaning cycle determination.

Designed required validation studies and protocols for the GSK facilities and equipment.

Supported facility and equipment design through Factory Acceptance Testing and equipment qualification (IQ/OQ/PQ) including protocol and report authoring as well as protocol execution.

Developed project plans/reports to support manufacturing of new products.

Revised existing validation procedures or validation master plans for accuracy and relativity to the equipment performance level or the manufacturing process.

Investigated atypical events and developed and implemented corrective actions.

Statistical analysis of critical data from validation studies to derive or verify operating parameters.

Assisted in the cleaning cycle/steaming cycle design for new product or new equipment.

Verified all validated equipment continues to meet the original validation acceptance criteria through the validation maintenance re-qualification program.

Coordinated with various departments to complete validation studies per the required schedule.

Responsible for gaining approval of validation protocols and final reports.

Document remediation in preparation for regulatory agency audits including the FDA, MHRA, and Health Canada.

Effective communication to vendors or other departments such as QA, QC, BPT, Engineering, and Production.

White Belt Certification

November 2005 – January 2008 GLAXOSMITHLINE King of Prussia, PA

Biopharmaceutical Manufacturing Associate I

Performed Product Risk Analysis on cell culture procedures and equipment.

Assisted management on critical process decision making (i.e. cell batch termination, scale up, etc.).

Audited manufacturing areas and equipment in accordance with cGMP standards.

Supported on-site inspections with Regulatory Agencies.

Scaled up production using 135L and 1250L bioreactors.

Reviewed batch records, logbooks, and other protocols for efficiency and completeness.

Revised batch records and various production procedures for accuracy and precision.

Trained fellow associates on current manufacturing protocols and equipment.

Comply with cGMP and GSK safety codes.

Interface with Provox and DeltaV

June 2005 – November 2005 Progenitor cell therapy Hackensack, NJ

Manufacturing Associate

Produced high level of documentation accuracy and clarity (cGMP and GLP).

Performed environmental monitoring in class 100,000 and class 10,000 suites weekly.

Responsible for daily monitoring of all equipment in each cleanroom.

Document custodian for all SOPs, batch records, and forms.

Operated or validated all manufacturing processes according to written procedures.

Manipulated cellular products to achieve high quality pre-determined outcomes.

Tested for nucleated cell counts, viability, WBC slide differential, sterility sampling, and tissue culture.

Cryopreservation of products using DMSO solution and rate-controlled freezers.

Proficient with operation of common laboratory instruments such as pH meters, centrifuge, and Microscopes.

EDUCATION

August 2001 – May 2005 Pennsylvania State University University Park, PA

Degree: Bachelors of Science in Biotechnology May 2005

ACTIVITIES & SKILLS

Active member of a non-profit organization Backyard Legendz

Impeccable organization skills with superior time management

Excellent oral and written communication

Microsoft Office Proficient

References available upon request

Contact this candidate