QA Operations Engineer (1 HC)

SGI; Oberwallis; On-site; CHF 110,000 - 150,000; Full time

Job summary

SGI in Visp, Switzerland seeks an experienced QA Operations professional to embed onsite QA support into GMP Biopharma shop-floor operations. The role focuses on automation-related batch quality oversight, batch record review, deviations, CAPA and change control to ensure compliant manufacturing.

You will collaborate with automation/DI SMEs, review exceptions, support inspections, and maintain contemporaneous documentation. Fluent English required; German nice-to-have.

Qualifications

• 8+ years in QA Operations within GMP biopharmaceutical manufacturing.
• Hands-on deviation, CAPA and batch record review experience.
• Eligible to work in Switzerland and onsite in Visp.
• Fluent in English; German is a plus.

Responsibilities

• Review batch records and automation-generated batch exceptions; escalate gaps.
• Support deviations, CAPA, change control and effectiveness checks.
• Conduct GMP walkdowns and assess temporary manual workarounds.
• Collaborate with automation SMEs on recipe changes and batch reconciliation.
• Support inspection readiness and disposition documentation without batch release authority.

Skills

Batch record review

Deviation investigations

CAPA

Operational change control

GMP biopharma

Tools

DeltaV/MES

eBR

TrackWise

Veeva

Job description

• Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.

Purpose

• Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.

Revised responsibilities

• Review batch records and automation-generated batch exceptions, escalating unexplained gaps or discrepancies.
• Support deviations, root cause, CAPAs, change control and effectiveness checks.
• Conduct GMP walkdowns and assess temporary manual workarounds and contemporaneous documentation.
• Work with automation/DI SMEs on recipe changes, alarm/event histories, historian evidence and batch record reconciliation.
• Support inspection walkthroughs and disposition documentation without assuming batch release authority.

Must-have requirements (recruitment)

• 8+ years (or 5+ with strong biologics floor experience, flagged for D09) in QA Operations within GMP biopharmaceutical manufacturing.
• Working knowledge of 21 CFR 210/211 and EU GMP; hands-on deviation, CAPA and batch record review.
• Eligible to work in Switzerland and able to work full time on site in Visp. Fluent English.
• Nice-to-have: German, mammalian cell-culture drug substance, DeltaV/MES eBR review, FDA inspection experience, Lean/Six Sigma, Veeva or TrackWise.
• CV keywords: batch record review, eBR, deviation, CAPA, biologics, 21 CFR 210/211, EU GMP, TrackWise, Veeva.

Critical competencies

• Direct QA Operations experience in GMP biologics manufacturing; 8+ years or equivalent depth (thresholds under D09).
• Batch record/eBR review, deviation investigations, CAPA and operational change control.
• Ability to interpret DeltaV/MES-generated batch exceptions with qualified SMEs; onsite work eligibility in Switzerland.

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

• No QA Operations experience in GMP biologics manufacturing.
• Not eligible to work in Switzerland, or unable to work full time on site.
• Not available on any of the listed start dates.

Minimum deliverables

• Reviewed batch records/exception logs and documented escalations.
• Deviation/CAPA reviews, floor-readiness observations and closure evidence.
• Inspection walkthrough readiness and prioritized open-quality issues.

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