5 Questions with Sainath Reddy Sanikommu, CQV CSV/CSA, Data Integrity and Automation Expert, PQE Group

Sainath Reddy Sanikommu serves as a CQV CSV/CSA, Data Integrity and Automation Expert for PQE Group in the US.  We spoke with Sainath to learn more about his background, current responsibilities, goals and interests as he works with clients to help solve their challenges and operate more efficiently on their journey to bring their products to market. 

1) Please introduce yourself to our audience by looking back at your education, training, and career path.

My name is Sainath Reddy Sanikommu. I have a Mechanical Engineering Bachelor’s Degree specialized in Automobile Manufacturing Engineering and a Master’s Degree in Industrial Engineering specialized in Quality, Lean Six Sigma and Supply Chain. Beyond my academic studies, I pursued specialized training in Lean techniques, Six Sigma techniques, GMP Regulations, validation principles, regulatory affairs and project management, all of which prepared me for real-world challenges in highly regulated environments. Today, I am excited to bring the combination of technical expertise, regulatory understanding and project management to consulting roles, where I can help companies solve challenges and stay at the forefront of innovation in the life sciences industry.

2) 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?

At PQE Group, I work as a CQV/CSV, Data Integrity and Automation consultant, focusing on validation and compliance projects across manufacturing and laboratory environments. My responsibilities include system validation, automation verification, and process optimization, ensuring regulatory compliance for our clients in the Biotech, Pharma and Medical Device sectors. I am also a part of the US subsidiary operations team. My main goals in this role are to deliver high-quality, tailored solutions that meet client needs, maintain compliance with evolving regulations like FDA, ISO and EMA standards, and help clients operate more efficiently and successfully bring products to market. I also strive to build strong client relationships by being a trusted and a proactive partner. What I enjoy most about my job is the diversity of challenges and the real-world impact. Every project is different, which keeps the work dynamic and interesting, and I find it very rewarding that our efforts directly support companies that are improving patient outcomes around the world.

3) Can you tell us more about why companies should consider partnering with PQE Group and what type of services you offer to your clients?

In the present day scenario of the life sciences industry, companies are facing incredible pressures – tighter regulatory scrutiny, faster innovation cycles, complex supply chains and increasing cost pressures. Partnering with PQE Group allows companies to navigate this complexity efficiently and with confidence. PQE Group offers a combination of deep scientific expertise, industry best practices and an external objective perspective. We are able to bring insights from multiple clients, industries and global markets, giving us options to not just solve the existing problem but also anticipate future challenges as well. Our services are special because we tailor our solutions to each client’s unique situation. We don’t offer ‘one-size-fits-all’ answers. Whether it’s helping a biotech firm accelerate clinical development, supporting a pharmaceutical company through digital transformation, or ensuring regulatory compliance for a medical device firm, we combine technical depth, business strategy, and hands-on execution to deliver lasting impact. Our teams stay embedded with our clients, acting as true partners rather than just external advisors. Ultimately, partnering with PQE Group empowers companies to innovate faster, manage risk more effectively and maintain a competitive edge ensuring scientific and regulatory excellence.

4) 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?

Yes, consulting is booming in life sciences as the professionals tend to realize that they can leverage their deep expertise and build new skills to have huge impact across pharma, biotech, medtech and healthcare industries. In my opinion, the following are the top skills a person would need to thrive as a life science consultant:

1. Scientific and technical expertise: Deep knowledge of GMP regulations, regulatory affairs and drug development pathways.

2. Problem-solving skills: Ability to breakdown issues, analyze them logically, and recommend practical solutions.

3. Business Acumen: Ability to understand business drivers and frame solutions that make business sense.

4. Communication skills: Ability to translate complex science into clear, actionable insights for both technical and non-technical stakeholders including report writing, presentations, and executive summary generation.

5. Project management: Ability to plan, execute, and deliver projects on time and within budget including task prioritization, timeline management and resource co-ordination.

6. Adaptability and learning agility: Ability to learn quickly, adapt, and stay ahead of trends.

7. Relationship building and emotional intelligence: Ability to build trust, credibility, and rapport with clients and internal teams and be able to incorporating listening skills, empathy, and influencing without authority.

5) Now for the fun question – what is the best piece of advice that you’ve ever been given?

The best piece of advice I have ever been given is: ‘Listen to understand, not to respond’. The real value, especially in the Life science industry, comes from truly listening to the client’s needs, asking the right questions, understanding their challenges deeply, and then crafting thoughtful, tailored recommendations. That advice helped me become a better consultant, a better teammate and someone clients trust because they know I am focused on their goals, and not just on having the quickest answer.