CPV/MSAT Consultant

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

Now Hiring: CPV / MSAT Consultant – 2 Positions (Waterford, Ireland | Onsite)

Can a control chart tell you more about a process than a batch record does? EFOR Group, a trusted Life Sciences consulting partner, is looking for two CPV / MSAT Consultants to join a global pharmaceutical manufacturer’s MSAT team in Waterford. The work is part of a network-wide quality transformation to harmonise validation and Continued Process Verification (CPV) across its sites. You’ll sit at the very start of the CPV chain: the plans you write will define the data that QC, Manufacturing and Digital teams go on to deliver.

What you’ll do:

• Write and update product CPV plans in line with a new global CPV procedure and templates


• Identify the CQAs, CPPs and in-process controls to trend, and define data sources and data requirements


• Set the statistical approach: control charts, alert/action limits, trend rules and capability indices (Cpk/Ppk)


• Run a gap assessment between current site CPV practice and the new global standard


• Support the site roll‑out of the CPV process, including change management and user training


• Define data requirements for the site’s digital data-contextualisation and trending platforms with MSAT and Digital colleagues


• Write CPV reports and support related change controls and deviations

Your background:

• 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 experience writing or owning CPV/OPV plans or reports, including at least one CPV programme or remediation on commercial products


• Strong knowledge of the process validation lifecycle (Stages 1–3) and ICH Q9 risk management


• Statistical process control and trending with JMP, Minitab or equivalent


• Experience with a CPV or trending platform (e.g. Discoverant, Seeq, PI‑based tools), sterile or biologics drug‑product experience, or a Lean Six Sigma Green Belt is a plus


• Clear technical writer, structured and autonomous, and comfortable challenging data and processes across MSAT, QC, QA, Production and Digital teams

Why EFOR Group?

EFOR brings together more than 3,200 experts in 18 countries, delivering technical, quality and engineering excellence across the full Life Sciences product lifecycle. Join a team shaping how a global manufacturing network turns process data into product quality.

Location:

Waterford, Ireland (onsite)

Contract:

approx. 9.5 months, starting October 2026