Senior Validation Engineer

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Shire Human Genetic Therapies Inc. for the following job opportunity:

JOB LOCATION: Lexington, MA

POSITION: Senior Validation Engineer

POSITION DESCRIPTION: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment: Execute approved protocols per company Good Documentation Practices (cGDP) and in accordance with cGMP, CFR 21Part11, 210 and 211, European Union (EU) regulations EU Annex 11, ICH Q7, Q8, Q9 and other applicable regulations, procedures and standard industry guidance; Identify discrepancies that occurred during execution of IOPQ protocols during manufacturing and laboratory equipment qualification; identify impact of the discrepancies on protocol, equipment or product; identify root cause and define corrective and preventive action procedure to resolve the deviations; write/draft discrepancy report; assist in performing non-conformance investigations for pharmaceutical manufacturing; Create/modify change control requests, project plans and maintaining project timelines; draft change control request and monitoring changes throughout the project for new and existing equipment or procedures in accordance with company and FDA regulations; define and own all necessary change control objectives to decommission the current equipment or to install/qualify the new equipment; Perform system level risk assessments and data integrity assessments; perform Electronic Records/Electronic Signature (ERES) risk assessment; Participate in review of manufacturing operational SOPs that apply to validated equipment; Author/review/approval of commissioning, qualification and validation lifecycle documents such as User Requirement Specification (URS), Functional Requirement Specification (FRS), Risk Assessment, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols, Requirement Traceability Matrix (RTM) and Validation Summary Reports (VSR) etc. per Food Drug Administration (FDA) and other US pharmaceutical regulations; Analyze validation data, prepare reports and make recommendations for changes and/or improvements; review/approval process for validation documents in Veeva Vault Documentum; Author and review responses to inspection observations and agency questions; author and review sections of regulatory filings and annual product quality reviews.; up to 40% remote work allowed.

REQUIREMENTS: Bachelor’s degree in Pharmaceutical Sciences or Pharmacy or related field plus 5 years of related experience. Prior experience must include: Ensure manufacturing process meets 100% quality by using automation tools control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens); Complete temperature mapping for 100+ temperature-controlled units; Apply understanding of regulations for implementation of projects and preparation of FDA standard documentation in accordance with cGXPs, GAMP5 and 21CFR Part 11 etc.; Complete document analysis using tools such as Track wise, Veeva, Kneat, or other common electronic documentation systems at 95% accuracy rate.; Manage project communications using Microsoft Teams operations.

Full time. $132,000.00 to $193,300.00 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0157394. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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