{"schemaVersion":"jobsearcher.job.v1","id":"fcea95bf350ed3746ee683a5","url":"https://jobsearcher.com/jobs/fcea95bf350ed3746ee683a5","canonicalUrl":"https://jobsearcher.com/jobs/fcea95bf350ed3746ee683a5","title":"Computerized System Validation Engineer I","description":"By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.\nJob Description About the role: 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.\nHow you will contribute: 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:\n\nAssist in testing equipment\n\nEnsure standards of quality, cost, safety, reliability, and performance are met in production processes\n\nInterpret plans, drawings, and specifications\n\nApply basic physics principles in routine situations\n\nEngage in systems engineering with a foundational understanding of system integration\n\nPerform basic software engineering tasks by following predefined rules\n\nFacilities, Utilities, and Equipment (FUE) PCS qualification\n\nUnit operations automation qualification with Honeywell, Delta V, and PLC- based systems\n\nComputerized systems validation\n\nProvide 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.\n\nIndependently designs, authors, executes and summarizes commissioning, qualification and/or validation studies. Partners with SMEs to ensure smooth and efficient execution of testing strategies.\n\nCollaboratively participates in risk and impact assessments.\n\nSupports development and review of standard operating procedures (SOP) and validation assessments.\n\nInterfaces with customers on technical issues, project timelines and validation support.\n\nActively participates in cross functional teams to determine the root cause and corrective actions for problems associated with investigations.\n\nCalculation and interpretation of data for commissioning, qualification and/or validation studies.\n\nParticipates in audits and regulatory agency inspections as a representative of the Engineering Validation team, as required.\n\nSupports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.\n\nProvides support for operations and communications with Program Managers.\n\nExercise 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.\n\nDemonstrates 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.\n\nParticipates in several small projects with simple to medium complexity features.\n\nServes on Tier 1 work stream teams.\n\nWhat you bring to Takeda: Bachelor’s degree in an Engineering discipline, preferred, or related computerized systems fields.\n\nRelevant experience in a GMP regulated environment is a plus.\n\nKnowledge of basic principles in various engineering disciplines.\n\nMinimum experience requirements of recently graduated up to 2 years in CQV and / or CSV desired.\n\nKnowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments is a plus.\n\nStrong organizational skills, excellent writing and communication skills.\n\nKnowledge with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio are a plus.\n\nKnowledge of paperless validation is a plus.\n\nValidation 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.\n\nImportant Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:\nWork in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.\n\nNeed to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.\n\nWork in a cold, wet environment.\n\nWork multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.\n\nWork around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.\n\nMay be required to work weekends, evenings, off-hours, extended periods of time.\n\nOccasionally, it may be required to lift items weighting up to 50 pounds, and be able to walk, stand, reach and stoop.\n\nNeeds to be able to gown and operate in an environment requiring gowning.\n\nUp to 10% of travel expected.\n\nMore about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.\nCertified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.\n#GMSGQ #ZR1 #LI-MA1\nTakeda Compensation and Benefits Summary\nWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.\nFor Location:\nUSA - GA - Social Circle - Hwy 278 U.S. Base Salary Range:\n$58,400.00 - $91,740.00\nThe estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.\nU.S. based employees may be eligible for short-term and/ or long-term incentives. 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.\nEEO Statement\nTakeda 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.\nLocations USA - GA - Social Circle - Hwy 278 Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt\nYes\n#J-18808-Ljbffr","company":"Initial Therapeutics","rawCompany":"initial therapeutics","city":"Social Circle","state":"GA","isRemote":false,"isActive":false,"createdAt":"2026-06-20T04:55:43.499Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computerized System Validation Engineer I","description":"By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.\nJob Description About the role: 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.\nHow you will contribute: 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:\n\nAssist in testing equipment\n\nEnsure standards of quality, cost, safety, reliability, and performance are met in production processes\n\nInterpret plans, drawings, and specifications\n\nApply basic physics principles in routine situations\n\nEngage in systems engineering with a foundational understanding of system integration\n\nPerform basic software engineering tasks by following predefined rules\n\nFacilities, Utilities, and Equipment (FUE) PCS qualification\n\nUnit operations automation qualification with Honeywell, Delta V, and PLC- based systems\n\nComputerized systems validation\n\nProvide 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.\n\nIndependently designs, authors, executes and summarizes commissioning, qualification and/or validation studies. Partners with SMEs to ensure smooth and efficient execution of testing strategies.\n\nCollaboratively participates in risk and impact assessments.\n\nSupports development and review of standard operating procedures (SOP) and validation assessments.\n\nInterfaces with customers on technical issues, project timelines and validation support.\n\nActively participates in cross functional teams to determine the root cause and corrective actions for problems associated with investigations.\n\nCalculation and interpretation of data for commissioning, qualification and/or validation studies.\n\nParticipates in audits and regulatory agency inspections as a representative of the Engineering Validation team, as required.\n\nSupports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.\n\nProvides support for operations and communications with Program Managers.\n\nExercise 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.\n\nDemonstrates 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.\n\nParticipates in several small projects with simple to medium complexity features.\n\nServes on Tier 1 work stream teams.\n\nWhat you bring to Takeda: Bachelor’s degree in an Engineering discipline, preferred, or related computerized systems fields.\n\nRelevant experience in a GMP regulated environment is a plus.\n\nKnowledge of basic principles in various engineering disciplines.\n\nMinimum experience requirements of recently graduated up to 2 years in CQV and / or CSV desired.\n\nKnowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments is a plus.\n\nStrong organizational skills, excellent writing and communication skills.\n\nKnowledge with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio are a plus.\n\nKnowledge of paperless validation is a plus.\n\nValidation 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.\n\nImportant Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:\nWork in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.\n\nNeed to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.\n\nWork in a cold, wet environment.\n\nWork multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.\n\nWork around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.\n\nMay be required to work weekends, evenings, off-hours, extended periods of time.\n\nOccasionally, it may be required to lift items weighting up to 50 pounds, and be able to walk, stand, reach and stoop.\n\nNeeds to be able to gown and operate in an environment requiring gowning.\n\nUp to 10% of travel expected.\n\nMore about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.\nCertified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.\n#GMSGQ #ZR1 #LI-MA1\nTakeda Compensation and Benefits Summary\nWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.\nFor Location:\nUSA - GA - Social Circle - Hwy 278 U.S. Base Salary Range:\n$58,400.00 - $91,740.00\nThe estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.\nU.S. based employees may be eligible for short-term and/ or long-term incentives. 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.\nEEO Statement\nTakeda 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.\nLocations USA - GA - Social Circle - Hwy 278 Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt\nYes\n#J-18808-Ljbffr","datePosted":"2026-06-20T04:55:43.499Z","dateModified":"2026-06-20T04:55:43.499Z","hiringOrganization":{"@type":"Organization","name":"Initial Therapeutics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Social Circle","addressRegion":"GA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"fcea95bf350ed3746ee683a5"},"url":"https://jobsearcher.com/jobs/fcea95bf350ed3746ee683a5"}}