Case Study: Addressing Validation Skills Shortages for a Start-Up Biologics Facility
Executive Summary:
In 2018, a Biologics start-up facility reached out to us as they faced a critical shortage of trained validation staff, threatening its operational capabilities and project timelines. Innopharma Technical Services partnered with the facility to design a comprehensive talent acquisition and training strategy to meet both their short term and longer-term needs.
Since then, our partnership continues to successfully deliver a pipeline of highly skilled validation professionals across key areas such as Cleaning Validation, Equipment Qualification, AIQ, CTU, and Compliance. This tailored partnership approach addressed their immediate skills gap but also established the sustainable workforce model that continues to deliver on their ongoing needs.
Background:
In 2018, our client, a Biologics start-up facility, faced significant challenges in hiring trained validation staff due to a widespread talent shortage in the region. The lack of skilled professionals hindered essential validation processes critical to the facility’s operations. Compounding this issue, the existing contracting model proved to be unreliable, with low staff retention rates further exacerbating the problem.
Challenges:
- Severe skills shortages across all validation areas.
- High dependency on a contracting model that suffered from instability and low retention, making long-term planning difficult.
Scope of Work:
Innopharma Technical Services partnered with the facility to tackle the issue by designing and implementing a structured program to:
- Identify, select, and train validation resources tailored to the facility’s needs.
- Cover critical validation and compliance domains, including:
- Cleaning Validation
- Equipment Qualification
- Automation and Instrument Qualification (AIQ)
- Computer System Validation (CSV)
- Quality Assurance (QA)
- Compliance and Technical Writing.
Key Successes:
This collaboration resulted in a successful six-year partnership, ensuring a consistent supply of trained validation staff with the right cultural and attitudinal fit for the organization. The key deliverables included:
- Deployment of trained resources in the following:
- Cleaning Validation
- Equipment Qualification including AIQ, and CTU
- CSV
- Compliance Experts.
Our tailored training and robust staffing strategy led to a sustainable resolution of the skills shortage issue, strengthening the facility’s operational stability.
