Computerized System Validation Engineer I

Takeda • Social Circle, GA

22h • Onsite

About The Position

Computerized Systems Validation Engineer I is responsible for supporting the engineering operations within the organization. This role involves applying theoretical knowledge to practical scenarios, ensuring quality, safety, and performance standards are met in production processes. The role supports Takeda's mission by ensuring reliable and efficient engineering operations.

Requirements

• Bachelor’s degree in an Engineering discipline, preferred, or related computerized systems fields.
• Relevant experience in a GMP regulated environment is a plus.
• Knowledge of basic principles in various engineering disciplines.
• Minimum experience requirements of recently graduated up to 2 years in CQV and / or CSV desired.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments is a plus.
• Strong organizational skills, excellent writing and communication skills.
• Knowledge with Microsoft office including Word, Excel, and PowerPoint.
• Needs to be able to gown and operate in an environment requiring gowning.

Nice To Haves

• Microsoft Project and Visio are a plus.
• Knowledge of paperless validation is a plus.
• Validation and/or system experience in the following applicable areas is a plus: Utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
• Protein purification from mammalian plasma and/or blood.
• Technical understanding and experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
• Direct experience with manufacturing operations and biotechnology processes is strongly desired.

Responsibilities

• Support site projects, technical transfers, and ongoing validation maintenance.
• Primarily responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies for any of the following major disciplines:
• Assist in testing equipment
• Ensure standards of quality, cost, safety, reliability, and performance are met in production processes
• Interpret plans, drawings, and specifications
• Apply basic physics principles in routine situations
• Engage in systems engineering with a foundational understanding of system integration
• Perform basic software engineering tasks by following predefined rules
• Facilities, Utilities, and Equipment (FUE)
• PCS qualification
• Unit operations automation qualification with Honeywell, Delta V, and PLC- based systems
• Computerized systems validation
• Provide technical support to change controls, investigations, deviations, and CAPAs.
• Individuals must work on simple to moderate assignments, where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
• Independently designs, authors, executes and summarizes commissioning, qualification and/or validation studies.
• Partners with SMEs to ensure smooth and efficient execution of testing strategies.
• Collaboratively participates in risk and impact assessments.
• Supports development and review of standard operating procedures (SOP) and validation assessments.
• Interfaces with customers on technical issues, project timelines and validation support.
• Actively participates in cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
• Calculation and interpretation of data for commissioning, qualification and/or validation studies.
• Participates in audits and regulatory agency inspections as a representative of the Engineering Validation team, as required.
• Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
• Provides support for operations and communications with Program Managers.
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• May determine methods and procedures on new assignments.
• Demonstrates continuous improvement with respect to increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
• Participates in several small projects with simple to medium complexity features.
• Serves on Tier 1 work stream teams.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees