Validation Positions with PPD® Laboratories

Vincent Pernice

Vincent Pernice, associate director of lab operations at PPD® Laboratories, is a four-year veteran of life at PPD. He manages a dedicated group of employees who are embedded with several clients to provide on-site expertise.

Interviewer: Can you provide a brief overview of the client staffing group within PPD Laboratories, as well as your role?

Pernice: The idea of the on-site full-time employee (FTE) model is to create a sustained group of talent within a client organization that can provide long-term support and work at the same level as the client, typically for more than two years at a time. The FTEs in this group are considered to be permanent full-time PPD employees, and receive full benefits from PPD including training and career advancement opportunities. The program is not designed for short-term needs, as in the case of a temporary agency.

My role is to manage this FTE group and ensure that clients’ needs are met. I believe that constant communication is an integral part of any working relationship, as is routine feedback.

Interviewer: How would you define “success” in the GMP Laboratory client staffing group?

Pernice: There are many roads to success within the on-site FTE group, with feedback from the client being the most critical. Success can be defined as hitting the ground running and taking on enough workload that the client sees immediate improvements in efficiency. Success can also be achieved through innovative thinking. Identifying areas for improvement and implementing strategies to address and correct those issues can truly bring beneficial results for the client.

Another way to succeed in this role is to apply a synergistic approach to achieve an overall efficiency or improve the status quo. The bottom line is that we all succeed when we exceed our clients’ expectations by building the value of our service and maintaining our reputation for quality.

Interviewer: What does a typical day look like for a lab support engineer working on-site with a key client?

Pernice: This lab support engineer’s responsibilities start with reviewing the client’s weekly priorities to ensure that all tasks are aligned and executed with other key members of the validation team. In this dynamic environment, the priorities are constantly changing.

This individual also prepares a daily list of tasks to be done, and adjusts the meeting schedule as necessary to meet the clients’ changing needs. The role is responsible for initiating deviations as well as corrective and preventative actions (CAPAs), and performs weekly laboratory walk-throughs to inspect the validated state of all instruments and equipment. The lab support engineer is responsible for updating the master list of current instrument and equipment status, and for providing uptime for the instruments’ validated state to be approved by the quality assurance (QA) team.

Our lab support engineers are charged with drafting the client’s master validation plans, computer software validation (CSV) protocols for new instruments and equipment IQ/OQ and PQ protocols. For each qualification or validation deliverable, the engineer provides a status update to the client’s end users. Maintaining a single point of contact for validation updates is imperative for this client.

Interviewer: What do you enjoy the most about working for PPD?

Pernice: My years of working at PPD have refined my perspective on what good customer service means. I feel flattered to work with a large CRO so well-known for quality service throughout the Pharma industry, as PPD routinely earns “Best in class” or “Best CRO” awards in various venues. This is largely due to management that understands and prioritizes our clients’ needs, even through periods of rapid growth.

Having worked in both Pharma and academia for a number of years, I’ve found management at PPD to be understanding of employees’ personal and professional needs, particularly the desire to develop in their roles. We have employees in FTE roles that have been with the FTE organization for more than 10 years.

Interviewer: Finally, what advice would you give to someone looking to develop a career with expertise in laboratory validations?

Pernice: As with anything else, start with the basics and go from there. If an opportunity to learn something new appears, you should take advantage of it. Take a training course. If your current employer has in-house training or allows you to cross-train, then benefit from that. It is really up to you to define your own path.

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