QA CSV Engineer

SGI; Oberwallis; On-site; CHF 150,000 - 190,000; Full time

Job summary

SGI is seeking an experienced QA/CSV professional to provide independent GMP QA oversight of computerized systems and prepare inspection narratives. The role requires direct FDA inspection exposure, strong knowledge of Part 11, Annex 11, and DI guidance, with DeltaV familiarity and travel to Visp (2 days/month).

The successful candidate will challenge risk justifications, validate CAPA evidence, and sign decisions only when appropriately delegated, ensuring readiness for regulatory inspections

Qualifications

• Substantial independent QA oversight of computerized systems in GMP (15+ years preferred; 10+ with strong oversight record flagged for D09).
• Direct FDA inspection experience (front room or back room) on computerized system or data integrity topics.
• Expert knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (Second Edition) and data integrity guidance (FDA, MHRA, PIC/S); QA experience on OT/automation systems, preferably DeltaV.
• Willing and able to travel to Visp 2 days per month. Fluent English.
• Nice-to-have: FDA 483/warning-letter remediation, biologics manufacturing, qualified GMP auditor, German.
• CV keywords: independent QA review, FDA inspection, 483, warning letter, Part 11, Annex 11, PIC/S, MHRA DI, DeltaV, CAPA.

Responsibilities

• Review/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence.
• Verify independence from authors/executors and identify unresolved GMP risks.
• Review DI controls and critical electronic-record lifecycle evidence with the DI specialists.
• Prepare QA-approved inspection narratives and coach technical SMEs; escape critical deficiencies.
• Recommend acceptance/rejection; sign as approver only if documented Lonza delegation permits (decision D05).
• Minimum deliverables: QA review log, challenge register and disposition decisions; review of critical validation/DI packages; escalation log and risk statements.

Skills

QA oversight

FDA inspection

Part 11 expertise

Annex 11

GAMP 5

DeltaV familiarity

Tools

DeltaV

Job description

• Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation.

Purpose

• Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation.

Revised responsibilities

• Review/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence.
• Verify independence from authors/executors and identify unresolved GMP risks.
• Review DI controls and critical electronic-record lifecycle evidence with the DI specialists.
• Prepare QA-approved inspection narratives and coach technical SMEs; escape critical deficiencies.
• Recommend acceptance/rejection; sign as approver only if documented Lonza delegation permits (decision D05).

Must-have requirements (recruitment)

• Substantial independent QA oversight of computerized systems in GMP (15+ years preferred; 10+ with strong oversight record flagged for D09).
• Direct FDA inspection experience (front room or back room) on computerized system or data integrity topics.
• Expert knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (Second Edition) and data integrity guidance (FDA, MHRA, PIC/S); QA experience on OT/automation systems, preferably DeltaV.
• Willing and able to travel to Visp 2 days per month. Fluent English.
• Nice-to-have: FDA 483/warning-letter remediation, biologics manufacturing, qualified GMP auditor, German.
• CV keywords: independent QA review, FDA inspection, 483, warning letter, Part 11, Annex 11, PIC/S, MHRA DI, DeltaV, CAPA.

Critical competencies

• Independent GMP QA CSV oversight and direct FDA inspection exposure; senior profile (15+ years preferred, D09 pending).
• Expert OT computerized systems, DeltaV/batch/historian control risks, Part 11, Annex 11, GAMP 5 and DI guidance.
• Ability to challenge weak risk justifications, insufficient evidence and ineffective CAPAs.

CV screening knock-out criteria (screening w/c 19-Oct-2026)

• No direct FDA inspection exposure.
• Execution-only CSV background without an independent QA oversight role.
• Not available to start between 2-Nov-2026 and 1-Dec-2026.

Minimum deliverables

• QA review log, challenge register and disposition decisions.
• Documented review of critical validation/DI packages and inspection readiness evidence.
• Escalation log and recommended acceptance/residual-risk statements.

We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.