Planning a CQV team for a pharmaceutical facility expansion

For a pharmaceutical facility expansion, start CQV workforce planning with the systems, evidence and decisions the project needs to deliver. A request for a number of engineers is only one part of that plan.

Commissioning, qualification and validation bring together engineering activity, documented evidence and quality oversight. For an Irish pharmaceutical employer, a useful team brief should connect specialist responsibilities to the site’s approved approach and the actual readiness of the work.

The following planning questions are intended to support that brief. The site’s pharmaceutical quality system and approved procedures should govern the technical work.

Establish the qualification and validation framework

The European Commission’s EU GMP Annex 15 sets out qualification and validation principles. Sections 1.1–1.5 address lifecycle planning, suitably trained personnel, quality oversight and a validation master plan or equivalent, including roles and responsibilities.

The Commission’s current EudraLex Volume 4 index lists this Annex as operational from 1 October 2015. Its original publication date should not be confused with a new requirement introduced in 2026.

For workforce planning, turn the site’s framework into an explicit responsibility map. Identify who prepares documents, who executes work, who reviews evidence and who has authority to approve progression. Use the site’s actual approval structure rather than assuming those responsibilities from job titles.

Scope the work by system and deliverable

Create a working inventory of the systems and packages within the expansion. For each one, record the intended deliverables, current status, dependencies and accountable lead.

A practical planning record could include:

• The system or equipment package and its agreed boundary.
• The required technical knowledge and relevant project experience.
• The documentation available and any information still outstanding.
• The expected execution activities and review requirements.
• Dependencies on construction, vendors, utilities or automation.
• The point at which the work will be handed to the receiving team.

Use this inventory to develop the workforce requirement. It gives a prospective specialist a clearer description of the assignment and gives the programme team a basis for testing whether the proposed resource fits.

Avoid presenting this inventory as a substitute for the qualification strategy. Its purpose is to translate approved work into a manageable resource brief.

Separate execution capacity from review capacity

When estimating the team, allocate time to document preparation, execution, review, issue resolution and completion. Record the internal contribution as well as the external resource requirement.

Annex 15 section 2.2 states that qualification and validation documents should be approved and authorised by appropriate personnel defined within the pharmaceutical quality system. Bringing in additional specialists does not, by itself, establish those approval arrangements.

Ask each workstream lead to confirm the expected review workload and availability of the relevant reviewers. Where the same person covers several packages, show that shared demand in the plan.

This makes the capacity discussion specific. It also gives the programme a place to record what should change if execution progresses faster or slower than expected.

Build the mobilisation plan around readiness

Before agreeing a start date, check what the specialist needs in order to carry out the first assignment. Suggested checks include site induction, required training, access permissions, approved procedures, document access and the readiness of the relevant system.

Assign an owner to unresolved dependencies. Distinguish “the person can start” from “the planned work is ready to start”. If those dates differ, agree what useful preparatory work can be undertaken and how the arrangement will be reviewed.

For a phased expansion, maintain a short forward look at upcoming packages. Record likely mobilisation dates, confirmed dates and the decisions required to move from one to the other. Do not present a provisional date as a commitment to either the specialist or the project team.

Assess experience against the assignment

A CQV title should be the beginning of the assessment. Ask for relevant experience with the type of system, documentation environment and responsibilities involved in the proposed assignment.

Useful discussion prompts include:

• Which comparable systems has the person worked on, and in what capacity?
• Which documents did they prepare, execute or review?
• How did they work with engineering, automation and quality colleagues?
• What site-specific training or familiarisation would this assignment require?
• What would they need clarified before accepting responsibility for the work?

Keep this assessment proportionate to the role. An execution specialist, a workstream lead and a programme coordinator should not receive an identical brief simply because they work within the same CQV programme.

Plan for completion and handover

Include the final evidence and handover activities in the resource plan. Agree who will collate records, resolve outstanding items and explain the status of the work to the receiving team.

Where an assignment is approaching its end, review open responsibilities before deciding whether to extend, reduce or release the resource. Record what has been completed and what remains with a named owner.

Ask the receiving team what it needs to take over the package. That conversation should happen while the people who performed the work are still available to explain it.

Define the engagement before building the team

Discuss whether the requirement is for individual specialists working within the existing site structure or a defined professional service engagement. In either case, document interfaces, responsibilities and the site’s retained oversight.

Berkley’s Life Science practice supports specialist workforce requirements across pharmaceutical and life science organisations. Share the system scope, programme phase, responsibilities and likely mobilisation dates when briefing the team.

Talk to Berkley about CQV workforce planning for your next programme.