Our Story

While working at Baxter, a bright engineer’s idea would lead to lifelong friendships and the eventual founding of BioTeknica.

After a company buyout, Ruben Capo, one of the electrical engineers, started his own validation services firm in February 1996 named Controlled Concepts. Former Baxter engineer and friend, Jorge Rodriguez, would moonlight with Ruben on several projects and as business picked up, they approached close friend and colleague, Braulio Ortiz, to join them in this new venture and by June 1996, BioTeknica was born — literally created on a napkin!

With growth as a priority, the trio hired another former colleague and close friend, Steve Maltz, to head up the firm’s sales and marketing efforts.

From day one, they rolled up their sleeves, often working long 16-hour days and through their persistent work, nearly 20+ years later, now under the leadership of five Principals including Julie Larsen and Mike Neaves, BioTeknica continues to successfully serve the engineering and regulatory needs of medical device and pharmaceutical manufacturers.

Our Principals

Ruben Capo
Ruben CapoPrincipal & Co-Founder

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Co-Founder Ruben Capo brings 19 years of experience in engineering and manufacturing in the pharmaceutical/biomedical/ medical device industry to BioTeknica. His responsibilities have included design, development, installation, and validation of large-scale equipment and process validation. Ruben has designed and developed automated systems for in-line weight checks (including SPC monitoring), liquid level, and in-line sampling during filling/capping/labeling operations. Additionally, he is highly skilled with PLC systems (for example, Allen Bradley, Siemens, Modicon, etc.) design and troubleshooting.

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Jorge Rodriguez
Jorge RodriguezPrincipal & Co-Founder

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Jorge is a co-founder of BioTeknica. He has more than twenty years of experience in the pharmaceutical, medical device and diagnostics industry with experience in project management, hands-on validation of both medical device and pharmaceutical processes including computer systems validation. Jorge has led large scale remediation projects across multiple sites including all facets of project from assessments, planning, deployment and implementation which have resulted in successful FDA Inspections.

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Braulio Ortiz
Braulio OrtizPrincipal & Co-Founder, COO

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Co-Founder Braulio Ortiz brings more than twenty years of experience in quality assurance, engineering, and manufacturing in the biomedical, pharmaceutical, and medical device industries to BioTeknica. He has extensive experience in design, installation, and continuous improvement of 21 CFR and ISO 9001 compliant quality systems as well as successful outcomes with FDA inspections, Consent Decree and Warning Letter responses. He also has experience developing technical organizations, as well as designing and leading strategic business initiatives. Braulio’s expertise includes quality systems improvement strategies, Six Sigma, Business Process Re-Engineering, facilities commissioning, validation, and cost reduction initiatives.

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Mike Neaves
Mike NeavesPrincipal & Director, Regulatory Compliance Services

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As a Principal, Mike brings more than 19 years of medical device industry experience in the areas of engineering, manufacturing and quality assurance to BioTeknica. A former Quality Systems Director for a Fortune 500 company, Mike has specific expertise in design, installation, and continuous improvement of 21 CFR Part 820 and ISO 9001 compliant quality systems as well as dealing with FDA and third party inspections, Consent Decree and Warning Letter responses. Additional expertise includes device design, manufacturing engineering, re-engineering and validation and management experience in quality, manufacturing, distribution, and customer service. Mike is a certified quality auditor (ASQ) and is also registered through IRCA to conduct ISO 9001 quality system assessments.

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Julie Larsen
Julie LarsenPrincipal & Director, Inspection Readiness Services

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Julie has more than 20 years experience with quality assurance and compliance in manufacturing, division, and corporate roles in medical device and pharmaceutical industries (17 years leadership experience in Quality operations and compliance). She has extensive experience with strategy, coordination, and management of FDA inspections, remediation of quality systems for compliance improvement as well as successfully addressing Consent Decree, Warning Letter and 483 responses.

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Our Story

While working at Baxter, a bright engineer’s idea would lead to lifelong friendships and the eventual founding of BioTeknica.

After a company buyout, Ruben Capo, one of the electrical engineers, started his own validation services firm in February 1996 named Controlled Concepts. Former Baxter engineer and friend, Jorge Rodriguez, would moonlight with Ruben on several projects and as business picked up, they approached close friend and colleague, Braulio Ortiz, to join them in this new venture and by June 1996, BioTeknica was born — literally created on a napkin!

With growth as a priority, the trio hired another former colleague and close friend, Steve Maltz, to head up the firm’s sales and marketing efforts.

From day one, they rolled up their sleeves, often working long 16-hour days and through their persistent work, nearly 20+ years later, now under the leadership of five Principals including Julie Larsen and Mike Neaves, BioTeknica continues to successfully serve the engineering and regulatory needs of medical device and pharmaceutical manufacturers.

Our Principals

Ruben Capo
Ruben CapoPrincipal & Co-Founder

READ BIO

Co-Founder Ruben Capo brings 19 years of experience in engineering and manufacturing in the pharmaceutical/biomedical//medical device industry to BioTeknica. His responsibilities have included design, development, installation, and validation of large-scale equipment and process validation. Ruben has designed and developed automated systems for in-line weight checks (including SPC monitoring), liquid level, and in-line sampling during filling/capping/labeling operations. Additionally, he is highly skilled with PLC systems (for example, Allen Bradley, Siemens, Modicon, etc.) design and troubleshooting.

HIDE

Jorge Rodriguez
Jorge RodriguezPrincipal & Co-Founder

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Jorge is a co-founder of BioTeknica. He has more than twenty years of experience in the pharmaceutical, medical device and diagnostics industry with experience in project management, hands-on validation of both medical device and pharmaceutical processes including computer systems validation. Jorge has led large scale remediation projects across multiple sites including all facets of project from assessments, planning, deployment and implementation which have resulted in successful FDA Inspections.

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Braulio Ortiz
Braulio OrtizPrincipal & Co-Founder, COO

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Co-Founder Braulio Ortiz brings more than twenty years of experience in quality assurance, engineering, and manufacturing in the biomedical, pharmaceutical, and medical device industries to BioTeknica. He has extensive experience in design, installation, and continuous improvement of 21 CFR and ISO 9001 compliant quality systems as well as successful outcomes with FDA inspections, Consent Decree and Warning Letter responses. He also has experience developing technical organizations, as well as designing and leading strategic business initiatives. Braulio’s expertise includes quality systems improvement strategies, Six Sigma, Business Process Re-Engineering, facilities commissioning, validation, and cost reduction initiatives.

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Mike Neaves
Mike NeavesPrincipal & Director, Regulatory Compliance Services

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As a Principal, Mike brings more than 19 years of medical device industry experience in the areas of engineering, manufacturing and quality assurance to BioTeknica. A former Quality Systems Director for a Fortune 500 company, Mike has specific expertise in design, installation, and continuous improvement of 21 CFR Part 820 and ISO 9001 compliant quality systems as well as dealing with FDA and third party inspections, Consent Decree and Warning Letter responses. Additional expertise includes device design, manufacturing engineering, re-engineering and validation and management experience in quality, manufacturing, distribution, and customer service. Mike is a certified quality auditor (ASQ) and is also registered through IRCA to conduct ISO 9001 quality system assessments.

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Julie Larsen
Julie LarsenPrincipal & Director, Inspection Readiness Services

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Julie has more than 20 years experience with quality assurance and compliance in manufacturing, division, and corporate roles in medical device and pharmaceutical industries (17 years leadership experience in Quality operations and compliance). She has extensive experience with strategy, coordination, and management of FDA inspections, remediation of quality systems for compliance improvement as well as successfully addressing Consent Decree, Warning Letter and 483 responses.

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medical device and pharmaceutical manufacturers served thus far
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