Senior CSV Systems Engineer — GMP Lab Expert

Curia Aalborg ApS; Albuquerque (NM); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Generous benefit options

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching

Learning platform

And more!

Job summary

Curia Albuquerque is seeking a Validation Engineer III, CSV to lead and enhance our computerized systems validation programs. You will help ensure laboratory systems are compliant, validated, and aligned with GMP operations, supporting Quality Management Systems and CSV initiatives.

Relocation reimbursement is available for qualified candidates. You will mentor teams, generate validation documents, perform risk assessments, and participate in site audits and regulatory inspections.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum of five years’ experience in computer systems validation in a cGMP setting.
• Experience with SDLC documents and regulatory expectations.

Responsibilities

• Validate electronic systems and applications per procedures and health authority regulations.
• Generate and execute validation documents to maintain current validated state.
• Collaborate across functions to define validation deliverables for new or changed systems.
• Provide guidance duringURS/FS/DDS/CS review and develop lifecycle documents.
• Support site CSV actions from audits and participate in site inspections.

Skills

CSV

GMP

FDA regs

Validation

Education

Bachelor’s degree in engineering

5+ years cGMP validation

Tools

SDLC documents

Job description

Curia Albuquerque is seeking a Validation Engineer III, CSV to lead and enhance our computerized systems validation programs. You will help ensure laboratory systems are compliant, validated, and aligned with GMP operations, supporting Quality Management Systems and CSV initiatives.

Relocation reimbursement is available for qualified candidates. You will mentor teams, generate validation documents, perform risk assessments, and participate in site audits and regulatory inspections.