validation consultant


Life sciences industries such as pharmaceutical and medical device manufacturing are some of the most highly regulated industries in the world. These companies rely on specialists to monitor, evaluate and implement validation activities to ensure that their processes are up to industry standards and that they are producing safe and effective products. Whether it’s measuring and analyzing processes, auditing and calibrating equipment, and/or creating a document trail to demonstrate that processes lead to a consistent, high-quality product, the use of multi-disciplinary teams to supplement Quality System activities have become a cGMP (Current Good Manufacturing Practice) expectation of the FDA and many other markets. 

As challenging as it is, having effective Validation strategies at each stage of the product lifecycle is crucial for success. While some Validation activities can be sourced via internal sources, due to the wide scope and complexity of Validation projects, each project should be evaluated to determine the best talent for its unique needs. This is why many of them require outside talent who can bring experience and specific expertise to ensure thoroughness and accuracy while saving time and money. 

Here are 5 key considerations when hiring the right validation consultant:

1. Unit Operations Expertise

Determine the level of skills and expertise you require from your validation consultant. While direct equipment experience could be concluded from a resume or CV, process experience has to be tested to see if a specialist fits the company and projects specific needs. Determine for what operations and at what level your organization needs the specialist to be, and prepare specific questioning for the interview process. 

One key question:

“What skills, capabilities, or experience are essential to ensuring those unit operations can be adequately supported?”

2. Specific Product Requirements

When looking for a specialist, it is important to be as detailed as possible about product requirements and to not overlook any steps no matter how trivial it may seem. Even though a candidate might seem a perfect fit otherwise, if they do not have experience with a specific part of the process, this might make them incompatible.

One key question:

“What are the specific requirements for the product, equipment, or project in question and what specific qualities, capabilities, or experience must a specialist have to satisfy these requirements?”

3. Environmental Requirements

Similar to “Specific Product Requirements,” determine whether the Validation team will be within a restricted environment, and if so, what requirements and expertise they need to comply with the working conditions. While experiences such as proper gowning might seem like over simplified bullet points, it is important to determine what experiences the work environment requires and to ask specific questions during the interview period accordingly. The best way to do so is by asking candidates how they would apply their experience to the project at hand to determine whether they are a good fit for the role. 

One key question:

“What specific environmental requirements apply for the product or project in question and what specific qualities, capabilities, or experience must a specialist have to satisfy these environmental requirements?”

4. Vision Inspection Systems

Some projects might require direct experience with vision inspection systems such as defect sets, defect logs, etc. These qualifications and expertise with specific equipment might be challenging to find depending on whether the project requires knowing the requirements of an area for highly specific validating camera systems. 

One key question:

“What are the specific equipment and their internal system requirements you are looking to validate and are there defect sets needed to validate such equipment?”

5. Strong Documentation Skills

While strong documentation skills might seem like an obvious requirement, it is important to make expectations abundantly clear. If the project requires drafting and producing documentation, the most compatible candidate should possess the skills to create an organized, coherent, and actionable protocol that complies with both internal SOPs and external regulations. 

One key question:

“What is the expectation for specialists in terms of protocol drafting and execution and what is the training process required prior to gaining access to the internal documentation control system?”

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