GMP IT CSV Specialist: ERP & Electronic Systems Validation

Run my Accounts AG; Edmonton; On-site; CAD 90,000 - 130,000; Full time

Benefits offered by this job

Health Coverage

RRSP Matching

Professional Development

PTO

Green Transit Allowance

Work From Home

Job summary

Applied Pharmaceutical Innovation (API) seeks a hands-on CSV validation professional to lead the validation lifecycle for software systems in GMP environments at our Edmonton-based operations. You will collaborate with Quality, Engineering and IT to develop IQ/OQ/PQ protocols, manage change control, and ensure compliance with Health Canada and FDA guidelines, including 21 CFR11 and GAMP5.

This on-site role requires 3–5 years of experience, a Canadian degree, and a proactive, results-driven

Qualifications

• Bachelor’s degree in engineering, IT, CS or related field from Canada.
• 3–5 years of applied CSV experience in pharma/medical devices.
• Experience with Health Canada and FDA GMP incl. 21 CFR11 and GAMP5.
• Experience with electronic quality management systems (QMS) and ALCOA+ data integrity.
• Strong analytical and communication skills; cross-functional collaboration.

Responsibilities

• Lead validation lifecycle for software systems in GMP environments.
• Develop IQ/OQ/PQ protocols, risk assessments, and test documentation.
• Collaborate with Quality and Engineering for CSV deliverables and audits.
• Ensure ERP and other electronic systems comply with regulatory requirements.
• Support IT qualification, change control, and audit readiness.

Skills

CSV validation

GMP knowledge

21 CFR 11

QMS expertise

Data integrity ALCOA+

Relational databases

SDLC understanding

Analytical skills

Communication skills

Education

Bachelor’s degree in engineering/IT/CS

Tools

ERP systems

HPLC

Job description

Applied Pharmaceutical Innovation (API) seeks a hands-on CSV validation professional to lead the validation lifecycle for software systems in GMP environments at our Edmonton-based operations. You will collaborate with Quality, Engineering and IT to develop IQ/OQ/PQ protocols, manage change control, and ensure compliance with Health Canada and FDA guidelines, including 21 CFR11 and GAMP5.

This on-site role requires 3–5 years of experience, a Canadian degree, and a proactive, results-driven