Lidia Cecilia Cadena Casas, CQV & CSV/CSA & Data Integrity Manager, shares her 20-year career journey through the pharmaceutical and medical device industries, highlighting her roles in equipment validation, global auditing, and her fulfilling consulting work at PQE Group.
Please introduce yourself to our audience by looking back at your education, training, and career path.
My name is Lidia Cecilia Cadena Casas. I received a degree in Pharmaceutical and Biological Chemistry at La Salle University in Mexico City, and I am currently studying for a Master’s Degree in Operations Engineering at Anahuac University. While I was studying for my undergraduate degree, I did a short internship for Procter & Gamble in their Investigation and Technical Center in Newcastle, UK, and worked on Qualifying a Gas Chromatograph for perfumes’ analysis. My full career path, which now represents the past 20 years, started at Eli Lilly Laboratories in Mexico City in Equipment Qualification and Process Validation, as well as process trouble shooting and optimization. During this time, I supported the equipment maintenance technicians from Germany, Italy, and the US, each of whom travelled every year to Mexico. I thought they were very fortunate, being able to travel around the globe – I found it so exciting! At that time, I also met the Global Process specialists that had worked on the development of some of the most important products for the company, including Cialis ® and Prozac®, and I referred to them as the “Rescue-Rangers” because every time we had technical problems, they helped us, either in person or remotely. I admired them so much; they were inspirational to me, and I wanted to be that person, the one who is consulted with to solve problems and to provide technical advice to others based on deep knowledge. That was a dream role for me, and one which I aspired to have some day.
I had spent five years at the Eli Lilly Mexico plant when it was closed. I then did an eight-month technical internship at Kanazawa University in Japan related to Drug Management and Disease Control Policies. This internship was sponsored by JICA (Japan International Council Association) and CONACYT, and it was my first approach to Medicines’ Quality Control outside of Mexico. We performed quality analytical tests for medicines sold in street markets in Cambodia and shared the results with the Cambodian Government and the medicines’ manufacturers. Living in Japan taught me a great deal about discipline and was an amazing multicultural working experience as I collaborated with Japanese, Saudi Arabian, Nepalese, Indonesian, and Vietnam colleagues and professors.
After returning from Japan, I gave Japanese lessons at Language School ACIA in CDMX, and at the same time, I joined Becton Dickinson (BD), a large Medical Device company. There, I was involved in the Compliance department and was trained by BSI as a GMP Auditor oriented in Risk Management; I was then given the opportunity to join a Validation Area for Ethylene Oxide Sterilization Processes for plastic and glass syringes. I was also in charge of the Biological Indicators Laboratory and I had my first position managing a team of 10 lab technicians. During my last stage with BD, I was also involved in the development of Sterilization processes for Culture Media using Gamma Rays.
I can share that moving from a Pharmaceutical Company to a Medical Device Company was a big shock since the Good Manufacturing Practices, although similarly oriented to build and keep the quality of the products, are specific to the type of industry and must be carefully handled. Pharma and MD cannot be treated equally and sometimes this is a big challenge to the people in leading roles, and even for GMP auditors.
Regarding additional education, my job experiences and interests have led me to a Project Management Diploma course at ITESM and a Soft Skills course at Anahuac University. I also love learning languages and I have studied Italian, some French, and currently I am learning Chinese because one of my goals is to work in Singapore, some day.
Can you share more about your specific role at PQE Group? What are your main goals in this role, and what’s your favorite part about your job?
I joined PQE at its Mexico City Office in 2016. At that time the Team consisted of less than 20 people. I was a Commissioning, Qualification and Validation (CQV) (formerly TQ) Senior Consultant and was in charge of performing equipment qualification projects for Pharma, MD and even for Cosmetics and Body Care Customers, working along with Italian PMs at this early stage. I also joined the Third Party Audit (TPA) Team as CQV oriented auditor and a technical trainer for CQV topics. From time to time, I also collaborated in CSV projects.
As the Mexico office matured and grew, I became a Project Manager and then Executive Consultant and the local reference person for the CQV for talented younger team members that joined the CQV team in Mexico and LatAm. I also learned a lot from them and their fresh ideas and served as a bridge between the local office and our CQV Global Managers based in Italy. I was also included as part of the C&Q Operations Team, now CQV Center of Excellence and was named to the L5 level. In addition, I supported the Sales Team, visiting customers with them and preparing technical offers for CQV projects.
During my first seven years with PQE I supported numerous projects in the USA, sometimes as an individual resource and others as a team member. As a TPA Auditor, I also performed numerous audits in USA and Canada on behalf of Mexican and European Customers. I love auditing since it makes you learn a lot, keeps you “updated” on the industry trends, and helps you to understand Quality Management Systems and how they meet Regulatory expectations. I have audited many different manufacturers — not only for traditional Medical Device and Pharmaceutical products – but I also audited a Cheese Factory where they produced lactose, excipient grade, and a Medical Device manufacturer of Injection Devices for horses and a Salt Manufacturer.
One of my most meaningful US projects was at Pfizer in Kalamazoo, Michigan during the pandemic. Here, along with five other colleagues I was a Project Manager for a team of almost 100 people of 15 different nationalities! The most profound aspect of this project was the complexity of coordinating such a big team, working seven days a week in three shifts. Working in this team taught me so much regarding human resources management; I became more aware of the most major challenges and at the same time, the exciting and interesting efforts required in dealing with multicultural teams that had very different beliefs but also completely common goals.
In 2024, I relocated to the Chicago office and since then, I have continued working on projects within the US as a local resource; I also have supported projects in Ireland and I am currently in Iceland, maximizing the opportunity that PQE provides to its employees by giving them the ability to collaborate on international projects around the world.
Can you tell us more about why companies should consider partnering with PQE Group and what type of services you offer to your clients?
As I mentioned before, meeting my own expectations from my younger days, we, the Consultants, are the “Rescue-Rangers.” PQE offers the best option for solving problems in those times of need. We are highly capable of providing the most specialized technical advice for developing work strategies in pretty much every area covering the product lifecycle, including CQV, Computer System Validation (CSV), and Compliance. We can develop full projects from start-to-finish in those – and numerous additional – areas and we have the best mixture of personnel support, with Technical Experts working in their respective fields, Project Managers to maintain the pace and tracking of the activities, as well as the work force to support the completion of tasks, always meeting the expected time and budget requirements.
Consulting is becoming a popular career path, particularly for scientists and medical professionals. What, in your opinion, are the top skills needed to be successful in a life science-focused consulting role?
Consulting is a great responsibility. We are hired to provide technical advice to solve problems and/or to define strategies. To me, Consultants must be eternal learners; we must learn and maintain ongoing industry knowledge, and must often be self-trained in order to fully understand new industry trends and the social and political contexts of it all. The good consultant is not the one that talks the most, but the one that listens, truly understanding the need of their Customers. In addition, a high degree of ethical responsibility is fundamental.
Now for the fun question – what is the best piece of advice that you’ve ever been given?
The best advice has come from my PQE mentors. My first Italian Project Manager once told me that “If what you are doing is too difficult, for sure you are doing something wrong.” It sounds trivial, but it is not. Instead, it is an invitation to avoid overthinking, to not waste energy on lost battles, but, overall, to always reflect, to stop and be self-critical, and, if needed, to redirect the course of our actions, often thinking out of the box when solving problems. A complementary idea to this is always to follow the KISS rule (Keep It Short and Simple).
In my time with PQE, I have had other great mentors; the first one taught me so many phrases and oriented me in so many different situations, and another mentor for me, technically speaking, is like a full book of responses and always offers great support when difficult situations on projects and with Customers have been faced.
My list of technical support colleagues, contacts, and friends in PQE is so long that I could fill this page naming every one of them. All of them are so talented and I am so grateful for all of their technical and life advices.
Now, when I look back and think about the dreams I had in my early career, I find myself doing my dream job, but even better.
