#40 Eddie "Z" Luchs: Regulations and Guidelines

Speaker: Griffin Hamilton  

Welcome to another episode of the modern facilities management podcast today I've got Z with me who is based out of San Diego. Z, how are you doing man? 

Speaker: Eddie  

Doing great this morning. 

Speaker: Griffin Hamilton  

Well I appreciate you taking the time to come on I know we've gone back and forth a bit but it's an absolute pleasure to meet you and finally talk facilities, so before we dive into it, why don't you give the audience a little bit of a background on who you are and how you got to facilities management? 

Speaker: Eddie  

So, I've been in biotech in San Diego 21 years in April, and I transitioned there in 2001, from military, I had a full career 24 years in the Navy, doing maintenance management and on submarines, diving systems, that type of thing. And the facilities profession looked like a good fit for my background, so I rolled into little startup, La hoya pharmaceutical back in 2001, and started out as a mechanic too. And then now I'm a director at a biotech in San Diego Sorrento Valley. 

Speaker: Griffin Hamilton  

Pretty cool and so taken a couple steps back into your military career, how did you get involved in becoming you know, making your career path out of maintenance?

Speaker: Eddie  

Well, I don't want to talk too much military jargon for people but, I was what they called a machinist mate. And so I spent a good part of my first year going to training learning about how to use tools change oil, work on turbans, and all that type of stuff. So it was a big machinery, marine machinery, turbans, boilers, eventually went to a nuclear submarine not as a nuke, but as an auxiliary man. And that was all air compressors and vacuum systems, refrigeration, which fit perfectly right into the facilities realm.

Speaker: Griffin Hamilton  

Got it, so you made a career in the military kind of do Facilities Management just now you've made the transition outside into the civilian world and to officially Facilities Management. So walk me through what that transition look like? 

Speaker: Eddie  

Well, at first, I used to utilize the GI bill out of the gate in a couple years before I actually retired and got my general education degree. And then I saw a book and it had an author in there who went to Ferris State University and had a bachelor's degree in H fac design and controls. And I thought, wow, that'd be really great. So I contacted that school. And they had an online course that you could take in H fac design and controls. And so I pursued that career, all the while I was working full time. And so Community College online bachelor's degree, and on the job training, and that transitioned me into higher and higher positions, because now I have my degree, I have years of leadership training in the military, and also got a minor in Business Management. So that all led into where I'm at now as a director of facilities. 

Speaker: Griffin Hamilton  

Got it, and so how did you make that transition into biotech? Because that isn't just, a normal industry. I would imagine you're actually the first facilities manager that I've talked to that's been a biotech. So let's dive into that industry specific to facilities. What does that look like? What does that entail? How did you get into it? 

Speaker: Eddie  

That's an interesting question. I was taking refrigeration classes at a local community college in San Diego, and one owner of a refrigeration company, particularly ultra-cold freezers, which is kind of a different than a regular refrigerator. It's negative 80 degrees C refrigerators. He had a company that did maintenance on those particular pieces of equipment, and he was having a hard time finding good mechanics. So he went into the classroom one night and asked the teacher who's getting the best grade point average. And so that happened to be me. So we had a little impromptu interview about three months before I got to the Navy, in the in the during the instructors office, and he hired me on the spot. So three months before I got, I had a job as a Refrigeration Technician working in San Diego, which all biotech industry has a lot of negative 80 freezers because they have that type of product that needs to be refrigerated to that level. So I got out went to work as a service technician. So I got my keys, my van and I drove around to different companies and I was doing preventive maintenance on freezers. And as I was driving around, of course, San Diego is a really busy town so I wasn't too pleased with having to drive around all day in traffic and take an hour and a half to get home from some locations. But I did see that almost every biotech had a facilities manager who was ex-military, and I thought well that's what I want to do. I want to be in the facilities department in biotech, not saying all biotech, but a good portion of were ex-military guys, officers and senior enlisted, and so I thought I probably had a pretty good chance of getting on facilities team. So I started as I was doing maintenance I was also networking and dropping off my resume at different biotech companies here in San Diego and took about a month and then I got hired on at LA Hoya pharmaceutical. And that's how I got into that part of the industry but the thing I liked about biotech is the equipment were well funded, well supported, they had great equipment, they've got the best air handlers, the best water systems, the best of everything because they are FDA approved, and they're making manufacturing a drug that goes into human beings so they needed to have very tight regulations and I had a strong background in quality from the military. So it all tied together very well as it transitioned.

Speaker: Griffin Hamilton  

Yeah, you're just out there hustling, going from client to client and then pass the resume on. I love that. So do you make this transition, you're now at a single location you're not driving around and you're dedicated facilities manager. So what does that look like as you've gone from military to a specialized mechanic working on the minus 80 refrigeration systems and now you have a whole building if I'm understanding you correctly, so what did that jump look like and how did you make that sort of transition of being specialists to now you're looking at facilities management and being across the board you got to cover everything floor to ceiling or I guess Florida roof of that building? 

Speaker: Eddie  

Yeah. Well, I'm a big fan of lifelong learning. So after I completed all my classwork and my bachelor's degree, there is an organization, it is International is called ISP, International Society of pharmaceutical engineers. And they write a lot of guidelines for the GMP industry, in the pharmaceutical industry. And there are a lot of regulations you have to understand plus all the codes having to do with building management and that's very common theme for anyone who is a facilities manager, you have to understand basic electrical code, building codes, ADA requirements. There's a lot of codes, tons of code, so you got to read a lot. So, I came into it right out of the military and really just I studied for, I'd say about, four to six years just I was constantly in seminars, San Diego Gas and Electric seminars, on motors and pumps and I would just completely immerse myself in the industry and became a student of not only facilities management but biotech industry, and I took a lot of courses through ISPE and also, more senior I got the more exposure I had to the requirements that were needed and eventually being audited by the FDA I would be the guy in hotseat explaining why my maintenance program was the way it was and how we were maintaining it and showing proof. I will say that the military taught me the value of good documentation and that has really carried through with me and it's been really my golden ticket was understanding documentation very well and how to present that to auditors.

Speaker: Griffin Hamilton  

Yeah, and so taking a couple steps back, you've alluded to the FDA several times. And so the guidelines there. I mean, you alluded to it. So we've got so many different guidelines, we've got to follow on facilities, but you're kind of throwing another layer on top of that with the FDA. So what makes that unique other than it's the FDA, I mean, what specifically made that more challenging than the other codes and regulations that we've got to follow as FM's? 

Speaker: Eddie  

Well it's more than like thermostat wars where this person's hot that person's cold he adjusted thermostats up and down and a backed up water closet or something like that when you are in manufacturing products that will be used by or injected into a human being there's a level of safety that you have no other place, because that drug or that product that you manufacture will be affecting the quality of human life. So there's that as a different layer that just basically human comfort and in basic safety as in going into a building and make sure everything is electrically safe and air quality is good and all that so the manufacturing aspect of it makes it very unique and really critical. You got to think about what you're doing each and every day. 

Speaker: Griffin Hamilton  

Yeah, and so with that, I mean, how do you stay on top of those regulations? Because I imagine they're evolving rather frequently, right? I mean, we've alluded to this on the show before but COVID, there's been regulations that have changed on what seems like a daily basis, but that's kind of immersed in that type of change and then need to be able to adjust when you're working with the FDA. 

Speaker: Eddie  

Well, you never stop, it's not one and done, okay, I got my degree, I don't have to go to school anymore. You're constantly going to school, you're constantly learning so you can never take your foot off the pedal, I just finished two major certifications. Well, they call me the triple threat, I've got the facilities, the FMP, the CFM. And now the sustainability facilities professional. So I didn't come up with that term. But so I just finished those certifications in 2021. And I don't know yet what 2022 will bring but there'll be another certification, there'll be another opportunity for learning and increasing my knowledge in the industry but it's continually learning you can never stop. 

Speaker: Griffin Hamilton  

Yeah, and I mean with the industry evolving as quickly as it is, that puts that much more of an emphasis on constant learning, continual learning there. And you got to take the initiative there. I mean, you mentioned yourself where you get a full career in maintenance in the military, where you got that foundation of yes the hands on, getting your hands dirty fixing and repairing things, but also the documentation and following guidelines to the tee. And yet you still spent the first four to six years after that career, immersing yourself in different technologies and different I guess, tools that you'd be working on and you've just mentioned it, this past year you got another certification, you're going to get another one this year. So it's never good you got to keep going. 

Speaker: Eddie  

Right, not only just getting a certification, but applying the fundamentals of it. And I got some really great advice from a facilities manager one time, and I was super great at the technical aspect of things. But he said the farther up the chain you go, the less technical it becomes, and more human it becomes. So I would say at this point, my role is 80% people skills and about 20% documentation and technical knowledge, I hired the smart people that understand the technical part of things and they can execute, but I've got to be the guy that really is the coach and the cheerleader and the guy that's, developing my team. And it's really about the human aspect, I deal a lot with senior management, and it's sometimes getting the right things in place is you got to put your salesman hat on and talk to them in the language that they understand in the C suite. It's about dollars and cents and how it's going to move the company forward. And so that becomes a big part of it too. And there's not really a school for that. I am going to plug LinkedIn a little bit, but LinkedIn learning has some great just really quick 30 minute tips on how to deal with the C suite and being a good role model for your team and someone is respected by the C suite, very, very important at this particular level. 

Speaker: Griffin Hamilton  

Yeah, and especially with facilities where it's oftentimes looked as, as a cost center, and at the end of the day, you're the one that's to go in and talk to the C suite and tell them this is an area where there's an opportunity to invest. And it's not just money going out, there's countless things that we could be doing to improve the processes that we already have in place. And yes it could be expenses going out, but we could reduce set expenses. And so putting that in a way that they can comprehend and it not getting too technical in the weeds from a facility standpoint, is extremely important. And so I guess with that, how have you gone about doing that? You mentioned LinkedIn and once again, constantly improving your skill set in from that standpoint, but how do you manage those type of expectations and then set expectations with the C suite on budget and investments surrounding your organization? 

Speaker: Eddie  

Well it’s part of the certification process through EFMA. There's also classes part of the certification process, there's 11 competencies in CFM. And one of them is financing and budgeting. Another one is leadership and also real estate. So understanding how that's all ties together for the business, those tools are presented to you in the EFMA certifications. And then, of course, the networking with other facilities managers. Sherry Perkins in the San Diego chapter president has done a phenomenal job of bringing us all together back in 2022. We've had a couple of in person meetings and she is just the most motivated person I think I've ever met and she motivates everyone else just by her being in the room. But she's done a fantastic job of getting everybody back together in person, the Zoom meetings and all that are okay the virtual stuff, but man being able to shake hands with people look them in a course from a distance with your mask on, but doing all the right things and talking to the other good people in the industry is how you learn these skills, and they're out there to support you, if you hit a bump in the road you go God, how would someone I respect, how would they deal with that. You have a phone call with them and you go wow, that's really a good point of view that I didn't think about. So it is a big network, being a facilities manager, tons of support, it's a tough job, it's 24/7 job, because buildings never sleep. And they get feisty in the middle of the night they decide to shut down and quit working and, your phone's got to be on all the time because we've got security and, and janitorial and all those other things that people never see. They're the little gnomes in the background that make the building shiny and work well. When they come back in in the morning, it just looks beautiful and they just assume that just happens. 

Speaker: Griffin Hamilton  

And it certainly doesn't, it certainly doesn't. It's great to recognize the people that do put in that hard work. And facilities, like you mentioned, buildings ever sleep, and they oftentimes probably more often than not, something breaks down or goes wrong whenever it's the most inconvenient time. So he got to be prepared at all times. Yeah, absolutely. So switching gears here a little bit, I know you've been in the biotech space for quite some time, but you made some comparisons. We've talked previously, to just how it's kind of in the manufacturing space more than anything, right, just how that is, I guess a unique component of it and there's nuances to facilities management in a manufacturing type facility. So I guess what does that look like and how does that compare to the traditional manufacturing facility people may be thinking of? 

Speaker: Eddie  

Yep, so you got to have a good plan in place, a good team and a good plan.

Speaker: Griffin Hamilton  

Yeah, so from my perspective, you're looking at what you guys are doing and the in product that you guys are creating, right? So FDA guidelines, it's going to be ingested by somebody versus cars, great example, it's just a physical product right? So I guess differences in similarities between the two, they're beyond the FDA regulations and guidelines there. 

Speaker: Eddie  

Well, you're talking about like putting together cars versus putting together bio reactors something or? 

Speaker: Eddie  

Well, first off, you got to remember that each person in manufacturing, and this is outside the facilities part of it, I can talk to that as well. But also, the people that are coming in each day to do the manufacturing to put the magic sauce together that's going to be bottled and set out, from the time that they step into their work environment, they're working in a bunny suit, sometimes double layers, triple layers of gloves, mask, just to get into the space to start their job is quite a feat in itself. And they have to be qualified and the room that they're in is constantly monitored for air quality and any type of impurities and so someone that's working in that space, they have to be very astute into how they move in the space, how they work in the space, and follow all the regulations, every single thing that could possibly compromise the product that they're working on. So that's something that's a little different. And you've got to have all the systems in place that can support that environment being how many air changes per hour and the quality of the air and HEPA filters purify the air and the water that goes into the product, there's several different layers of that, that's way too deep to talk about here. But every everything is of the highest purity and the highest standard. And it can never be an interruption of the airflow or the water flow at any time during the process. And so it's very stringent environment and latest constantly monitored, and then should something happen. That's where the paper meets the road there. The slightest deviation or non-compliance results in, it could be a couple a couple of days where the paperwork to explain why it happened. And then you have to put together a plan why it will never happen again. So I mean the documentation piece is the big difference between putting together a Chevy widget or an automobile widget or putting together a drug that's going to be bottled up and eventually injected into a human being. 

Speaker: Griffin Hamilton  

And I mean, I would imagine that those best practices can be translated as well right where just because the I guess the end result and repercussions of quote unquote failure aren't as severe in the car manufacturing facility down the road. That process and that strategy could still be implemented, right, it's maintaining and establishing what this looks like and making sure that you're following those processes and procedures to the tee. 

Speaker: Eddie  

That's true. And there's a big quality philosophy that Deming put together years and years and years ago, like in the 50s, or actually, maybe even the 40s. But it's the manufacturing things build quality into every step that you do. And I know, they're doing that in Detroit, they're doing it in all car manufacturers, because, they don't want to build cars that are going to fail, they want cars are going to last 200 or 300,000 miles. And people have a good experience and no failures along the way. So all those things all do play into that. The biggest thing is they don't have to put on three layers of clothing and be in bunny suits and, be tested and swabbed as they walk into the department to put together the radiator. 

Speaker: Griffin Hamilton  

And so as far as going in and establishing what those best practices are, because people that are listening, they may not be, you know, working at one larger facilities out there, and they could be working for a startup. And, this is one of their projects, right? Their initiatives of establishing these guidelines. And so how can one go about and either from scratch establishes best practices and these guidelines that you're going to be following or two, kind of take a step back and look at okay, here's what we're doing right now. And to your point of having qualitative every single step of the way. Let's improve that quality. Let's make adjustments, let's evolve over time and not just say it's done and it's good forever. So what are some best practices or some good takeaways that people could have that are listening that can kind of get started in the right direction there? 

Speaker: Eddie  

So as far as if you're on a team, let's say you're a director of facilities, and you've got half a dozen, maybe 10 people in a company that are experienced in this environment, which you need to do. And there's lots of great companies out there, that that consult. They've, they've been through it, they've got 20 years experience they got validation engineers, they have experienced writing SOPs, they have experience training, I mean, there was a company that came in and one of the biotech’s I was in and teach you how to work in a cleanroom. The methodologies and all the things that you do to prevent deviations and noncompliance issues when you're in there working. So there's a whole host of consulting thought firms out there that will help you with that. And you have to get those folks in there to help you out. Because you can't do it by yourself, there's just too much. And it's too big a nut to crack by yourself with just a few really motivated senior management folks, you got to get a team on board to help you get there. And where I'm currently at, we're going to have a product launch. At some point in the year, maybe the next year. But in in that process, all that aside, we have to become ISO 9001 certified. And so for that to happen, we need to bring in consultants to help us figure out which rooms that need to be validated, do our freezers need to be validated and all the mapping and things that go with that. But that will all be done by consultants and helping us write to standard operating procedures or SOPs and work instructions that we need. So you've got to reach out and you've got to build your team. Again, it's all about teamwork. And you're not going to hire all those folks as full time employees or FTEs. You've got to get those folks in as a temporary basis for six months, maybe 18 months to help you get from point A to point B in the process.

Speaker: Griffin Hamilton   

Yeah, and that is, like I said, it's about building the network and actually having those resources. And again, that goes back. It costs money at the end of the day to have a consultant come in and help out. Going back to having that conversation with the C suite and explaining why here's exactly why we need x, y & z to occur, and how it's going to have an impact on the business and the game with the end in mind, right? So wanting to have the big picture, here’s the results that we get expect, here's the investment but here's, like I said, the improvement in quality or just the overall process that we have as we move forward that just laying the foundation for a better future for the organization as a whole. 

Speaker: Eddie  

Right, yeah, it's a gamble. You can go to too big, too fast, add too many employees. There's, 1000 ways to do it wrong. And is only a couple of good ways to do it right. And some of it has to do with luck. Some of it has to do with good leadership and planning. But yeah, you just never know. 

Speaker: Griffin Hamilton  

Yep, absolutely. That's, again, relying on your network and the experts at your fingertips and making the best decision for you, your team and the organization as a whole. But Z I do have one last question as we're wrapping up here and I asked this to everybody that comes on and I never prep anyone so don't feel bad that it didn't let you know ahead of time but, who or what has had the biggest impact on you and your career? 

Speaker: Eddie  

I'm going to give that shout out to my wife. Yeah, so she has always been my rock and she is, you know... it's not easy to you know.., I'll say I've been at 10 biotechs in 20 years and you have to take some risks and she's always been my co pilot and she said well, if you think you got to the right stuff to make that work go for it. And so far it's worked out well because she's always been there and been supportive. So I've given her the number one kudos for why I've been successful in my career 

Speaker: Griffin Hamilton  

Smart man. 

Speaker: Eddie  

She's just in the next room, so she probably heard that I'm not sure if she did or not. 

Speaker: Griffin Hamilton  

Love that and you got to take the snippet. Maybe I'll add it for you and send it on over have that in your back pocket whenever you need it. That's great. Well, Z certainly appreciate you coming on. It's been a pleasure talking with you here, this afternoon for me. But yeah, absolute pleasure. I appreciate the insight and look forward to staying in touch. 

Speaker: Eddie  

It was really great talking with you. Alright, take care.

Speaker: Griffin Hamilton  

Alright take care Z.