Computerized System Validation Engineer I
Takeda
4 hours ago
On-site
Social Circle, GA
$58,400 - $91,740 USD yearly
IT
Computerized Systems Validation Engineer I
Responsibilities:
- Support site projects, technical transfers, and ongoing validation maintenance
- Design, author, and execute commissioning, qualification, and/or validation studies (e.g., FUE PCS qualification; unit operations automation qualification with Honeywell/DeltaV/PLC-based systems; computerized systems validation)
- Assist in testing equipment
- Ensure quality, cost, safety, reliability, and performance standards are met in production processes
- Interpret plans, drawings, and specifications
- Apply basic physics principles; perform systems engineering with foundational system integration knowledge
- Perform basic software engineering tasks by following predefined rules
- Provide technical support to change controls, investigations, deviations, and CAPAs
- Independently design, author, execute, and summarize validation studies; partner with SMEs
- Participate in risk/impact assessments; develop/review SOPs and validation assessments
- Interface with customers on technical issues, project timelines, and validation support
- Support root-cause and corrective actions for investigation issues; calculate/interprete data
- Participate in audits and regulatory inspections as needed; support development of validation best practices
- Support operations communications with Program Managers; serve on Tier 1 work stream teams
Qualifications (What you bring):
- Bachelor’s degree in Engineering (preferred) or related computerized systems fields
- Up to 2 years in CQV and/or CSV (recent graduates desired)
- Relevant experience in a GMP regulated environment (plus)
- Knowledge of Industry guidelines (ISPE, PDA) and US/international GMP regulations (FDA, ICH, ISO, EU) (plus)
- Strong organizational skills; excellent writing and communication skills
- Proficiency with Microsoft Office (Word, Excel, PowerPoint); Microsoft Project/Visio (plus)
- Paperless validation knowledge (plus)
- Plus: utility systems validation, temperature mapping, equipment commissioning/qualification, protein purification from mammalian plasma/blood, and automation platforms (DeltaV, Honeywell, Rockwell PLC, Siemens XFP); direct manufacturing operations/biotech process experience strongly desired
Important considerations:
- Controlled manufacturing environment (gowning/PPE); cold/wet conditions; possible weekends/shifts and extended hours; work around chemicals requiring respiratory protection; occasional lifting up to 50 lbs; up to 10% travel expected.
Responsibilities:
- Support site projects, technical transfers, and ongoing validation maintenance
- Design, author, and execute commissioning, qualification, and/or validation studies (e.g., FUE PCS qualification; unit operations automation qualification with Honeywell/DeltaV/PLC-based systems; computerized systems validation)
- Assist in testing equipment
- Ensure quality, cost, safety, reliability, and performance standards are met in production processes
- Interpret plans, drawings, and specifications
- Apply basic physics principles; perform systems engineering with foundational system integration knowledge
- Perform basic software engineering tasks by following predefined rules
- Provide technical support to change controls, investigations, deviations, and CAPAs
- Independently design, author, execute, and summarize validation studies; partner with SMEs
- Participate in risk/impact assessments; develop/review SOPs and validation assessments
- Interface with customers on technical issues, project timelines, and validation support
- Support root-cause and corrective actions for investigation issues; calculate/interprete data
- Participate in audits and regulatory inspections as needed; support development of validation best practices
- Support operations communications with Program Managers; serve on Tier 1 work stream teams
Qualifications (What you bring):
- Bachelor’s degree in Engineering (preferred) or related computerized systems fields
- Up to 2 years in CQV and/or CSV (recent graduates desired)
- Relevant experience in a GMP regulated environment (plus)
- Knowledge of Industry guidelines (ISPE, PDA) and US/international GMP regulations (FDA, ICH, ISO, EU) (plus)
- Strong organizational skills; excellent writing and communication skills
- Proficiency with Microsoft Office (Word, Excel, PowerPoint); Microsoft Project/Visio (plus)
- Paperless validation knowledge (plus)
- Plus: utility systems validation, temperature mapping, equipment commissioning/qualification, protein purification from mammalian plasma/blood, and automation platforms (DeltaV, Honeywell, Rockwell PLC, Siemens XFP); direct manufacturing operations/biotech process experience strongly desired
Important considerations:
- Controlled manufacturing environment (gowning/PPE); cold/wet conditions; possible weekends/shifts and extended hours; work around chemicals requiring respiratory protection; occasional lifting up to 50 lbs; up to 10% travel expected.