Computer System Validation Specialist at Baxalta U.S., Inc. in Round Lake, Illinois

Job Description:

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Job Description

The Computer System Validation Specialist will be responsible for qualifying the equipment and systems used to manufacture products within a manufacturing facility located in Round Lake, IL.  You will ensure systems operate to meet necessary specifications and regulations to ensure data integrity and the manufacture of quality products.

Role Responsibilities

• Execute multiple large and small scale projects


• Support design changes, continuous improvement projects, and provide insight.


• Schedule and execute validations protocols per Standard Operating Procedures (SOPs) and regulatory guidelines.


• Coordinates and communicates all testing with affected functional groups and evaluates test results.


• Executes equipment, facility, utility, computer system, and Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.


• Participates and presents data in Regulatory Agency, Customer, Corporate and Internal audits.


• Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.


• Thorough understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation, such as, but not limited to GAMP 5 and ASTM E2500.


• Perform Electronic Record/Electronic Signature (ERES) Assessments.


• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.


• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.


• Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).

Qualifications

• Degree Requirements: BS/BA degree in science, engineering, manufacturing technology or closely related field or 2+ years of validation experience


• 3-5 years of experience in pharmaceutical industry strongly preferred


• 1-2 years of validation experience required


• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices


• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products


• Must be proactive, have experience with high performance teams, strong interpersonal and project management skills


• Must be able to interact with varying levels within the company


• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results


• Strong conflict resolution skills


• Must be able to work multiple shifts as needed to meet deadlines


• Must not be allergic to Cephalosporins #LI-DW1

This Job posting excludes CO applicants

#GMSGQ

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Worker Sub-Type

Time Type

Full time