CPV/MSAT Consultant — Pharma QC Transformation (Onsite Waterford)

EFOR; Waterford; On-site; EUR 65,000 - 90,000; Full time

Job summary

EFOR Group, a Life Sciences consulting partner, seeks two CPV / MSAT Consultants for Waterford, onsite engagement. You will write CPV plans, identify CQAs/CPPs, and define data for trend analysis across QC, Manufacturing and Digital teams.

Applicants should have 3–7 years in GMP pharma or CDMO environments, CPV experience, and familiarity with statistical tools and CPV platforms. The role supports a global CPV rollout and includes change management responsibilities.

Qualifications

• Degree in Chemical, Biochemical or Process Engineering, Pharmacy, Chemistry, Biotechnology or similar.
• 3–7 years in GMP pharma, biopharma or CDMO manufacturing, in MSAT, process engineering or validation.
• Hands-on CPV/OPV plans or reports experience, with at least one CPV programme or remediation.

Responsibilities

• Write and update CPV plans in line with global CPV procedure and templates.
• Identify CQAs, CPPs and in-process controls to trend; define data sources.
• Set the statistical approach: control charts, alert/action limits, trend rules, CpK/CpK.
• Run gap assessment between current CPV practice and new standard.
• Support site rollout of CPV, including change management and user training.
• Define data requirements for digital data-contextualisation and trending platforms.
• Write CPV reports and support related change controls and deviations.

Education

Degree in Chemical, Biochemical or Process Engineering, Pharmacy, Chemistry, Biotechnology or similar

Tools

JMP

Minitab

Discoverant

Seeq

PI-based tools

Job description

EFOR Group, a Life Sciences consulting partner, seeks two CPV / MSAT Consultants for Waterford, onsite engagement. You will write CPV plans, identify CQAs/CPPs, and define data for trend analysis across QC, Manufacturing and Digital teams.

Applicants should have 3–7 years in GMP pharma or CDMO environments, CPV experience, and familiarity with statistical tools and CPV platforms. The role supports a global CPV rollout and includes change management responsibilities.