Quality Engineer CSV And Digital Systems

• The Quality Engineer CSV & Digital Systems is responsible for ensuring compliance, validation, and data integrity of computerized systems used in regulated manufacturing environments.
• This role focuses on Computer System Validation lifecycle oversight, digital manufacturing platforms, and cross-functional collaboration to enable compliant and efficient project execution.
• The position ensures alignment with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles while supporting inspection readiness and digital transformation initiatives.

Computer System Validation:

• Review and approve CSV lifecycle documents including VMP, URS, FRS, HDS, Risk Assessments, IQ, OQ, PQ, RTM, and Summary Reports.
• Ensure risk-based validation approaches align with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ principles.
• Evaluate system changes through change control processes and assess GxP impact and validation requirements.
• Support periodic reviews and revalidation activities for existing systems.

• Act as Quality reviewer and approver for MES and EBR platforms.
• Review and approve historians such as OSIsoft PI or equivalent systems.
• Provide oversight for advanced analytics tools used for GxP trending.
• Review and approve laboratory systems including Empower and similar platforms.
• Evaluate configurations related to data acquisition, timestamping, audit trails, access control, and electronic records and signatures.
• Ensure proper segregation between GxP and non-GxP analytics use cases.

• Assess and approve data flows, interfaces, and system integrations.
• Support regulatory inspections and internal audits related to computerized systems.

• Partner with Engineering, Automation, MS&T, IT, and Operations teams to enable compliant validation strategies.
• Provide Quality input during project design, FAT, SAT, commissioning, and implementation phases.
• Balance risk-based validation to avoid over-validation while maintaining compliance and inspection readiness.

• Master s degree in Engineering, Computer Science, Life Sciences, or related field.

• 3 to 5 years of experience in pharmaceutical or regulated manufacturing environments.
• Minimum of 2 years of experience within a Quality organization.
• 3 or more years of hands-on CSV experience reviewing and approving validation documentation.
• Direct experience supporting manufacturing or utilities systems.

• Strong knowledge of CSV lifecycle and GAMP 5.
• Strong knowledge of 21 CFR Part 11 and Annex 11 requirements.
• Strong understanding of Data Integrity principles including ALCOA+.
• Practical experience with MES and EBR systems.
• Experience with process historians such as PI systems.
• Experience with advanced analytics platforms in a GxP environment.
• Ability to evaluate risk-based validation approaches for dashboards, reports, and models.
• Familiarity with change control, deviation management, and CAPA systems.

• Experience with Werum PAS-X, Seeq, PI Vision, or Power BI for regulated trending.
• Experience with agile or lean validation approaches.
• Experience integrating Commissioning and Qualification activities with CSV.
• Prior involvement in regulatory inspections related to computerized systems.
• Experience supporting digital transformation or Industry 4.0 initiatives.

• Strong risk-based decision-making with a focus on quality and compliance.
• Excellent documentation review and technical writing skills.
• Ability to provide constructive challenge while remaining solution-oriented.
• Comfortable working across Quality, Engineering, and IT functions.
• Pragmatic mindset focused on compliance and business enablement.