Vakula Connect, Q3 2022: CSA draft guidance and the shift to risk-based validation

Our Q3 2022 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.

Vakula Connect, Q3 2022: CSA draft guidance and the shift to risk-based validation

Vakula Connect is our regular update for consultants deciding where to take their next assignment and for clients planning their next programme. This edition covers Q3 2022.

Market signals

  • FDA's draft Computer Software Assurance guidance in September gave validation teams permission to focus testing on risk; clients began asking for engineers who could write the risk rationale, not only execute scripts.
  • Biotech funding tightened and some smaller sponsors slowed hiring, while large pharma and CDMOs kept recruiting for quality and manufacturing roles.
  • Pharmacovigilance case volumes stayed high, keeping drug safety associates in demand.

Roles in demand this quarter

Titles that recurred in client requisitions: Validation Engineer (CSA), Drug Safety Associate, Manufacturing Quality Engineer, QA Automation Engineer. Current openings are always on our careers page.

Signal to leaders

The disciplines that were hardest to fill were the ones where clients needed judgement as well as capacity; briefing for the judgement shortened time-to-fill.

At Vakula

Our validation consultants started building CSA-style packages for new systems. We also formalised the intake call: a consultant from the discipline takes every brief, so the shortlist reflects the work rather than the keywords.

For consultants

Rate, duration, location and client are disclosed before you decide to interview; you get feedback after every submission; there are no fees to candidates at any stage. Send your resume.

For clients

Send one requisition and judge the shortlist. Start here.

Join the conversation

Tell us what you are working through at info@vakulatech.com; we may feature the question in a future edition.

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