Validation Lead
Current
Mar 2020 - Present
AeroLeads people directory · profile
Greg Holzer Email & Phone Number
Validation Lead
at
Novo Nordisk
1 work email found
@novonordisk.com
2 phones found area 919
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Who is Greg Holzer? Overview
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Quick answer
Greg Holzer is listed as Validation Lead at Novo Nordisk, based in Raleigh, North Carolina, United States. AeroLeads shows a work email signal at novonordisk.com, phone signal with area code 919, and a matched LinkedIn profile for Greg Holzer.
Greg Holzer previously worked as Project Quality Manager at Nne and Lead Quality Engineer at Nne. Greg Holzer holds Bachelors, Mechanical Engineering from Virginia Tech.
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Email format at Novo Nordisk
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{first_initial}{last}@novonordisk.com
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AeroLeads found 1 current-domain work email signal for Greg Holzer. Compare company email patterns before reaching out.
Profile bio
About Greg Holzer
Gregory Holzer, who goes by Greg, is a Project Quality Manager and CQV Team Lead with more than 14 years of experience in the Biotech and Pharmaceutical industries. With a background in Quality Assurance and Project Management, he has contributed as a team leader and quality lead on both large and small scale projects. His most recent project achievements involved him supporting a major restructuring of a client’s global validation strategy to align with ASTM E-2500 industry standards. Specifically, as an author and contributor to multiple project instructions and as a lead instructor supporting the training of over 200+ project team members, Greg has supported efforts to set direction for successfully carrying out commissioning and qualification activities. Prior successes involved him providing quality oversight and project tracking for a large scale automation services project encompassing the design and commissioning of a process control system, environment monitoring system, Building Management System (BMS), and Historian data collection server. Serving as QA Lead on a variety of automation and validation projects, Greg is adept at managing and coordinating multi-disciplined teams of professionals. His understanding of Good Automation Manufacturing Practices (GAMP) stems from extensive experience writing and reviewing quality engineering deliverables from commissioning, qualification, and validation protocols/plans to detailed user, functional, and design requirement specifications. Prior to his involvement in Quality Assurance, Greg managed projects involving turn-key filtration and chromatography systems. His role as a project manager included a full range of responsibilities from project estimation, procurement, design management of internal and contract resources, review and approval of project documentation, creation of testing protocols and reports, and oversight of all related factory acceptance testing and shipping activities.
Listed skills include Validation, V&V, Gmp, 21 Cfr Part 11, and 4 others.
Current workplace
Greg Holzer's current company
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10 roles
Greg Holzer work experience
A career timeline built from the work history available for this profile.
Project Quality Manager
Responsible for reviewing client requirements and operating procedures against general contractor/supplier testing documentation to ensure testing completeness and compliance. Supporting project quality leadership on $2 Billion + project by generating and reviewing project instruction guidelines intended for use by all work package owners and field testing.
May 2017 - Mar 2020
Lead Quality Engineer
Greenfield Project - Automation Network, SCADA, & PCS Systems for Fill/Finish FacilityResponsible for providing quality oversight and project tracking for a greenfield multi-building project encompassing the design and commissioning of a full SCADA application suite, process formulation systems, process clean utility systems, GMP HVAC, and equipment.
Jun 2015 - Apr 2017
Lead Quality Engineer
Greenfield PCS/BMS/Environmental Monitoring Systems Automation Project at a Fill/Finish FacilityResponsible for providing quality oversight and project tracking for a greenfield project encompassing the design and commissioning of a process control system, environment monitoring system, Building Management System (BMS), and Historian data collection.
Aug 2014 - Feb 2015
Lead Quality Engineer
PLC5 Upgrade Project at a Pharmaceutical Manufacturing FacilityResponsible for the generation of the project’s commissioning, qualification, and trace matrix documents. Performed quality reviews and oversaw the progress of all lifecycle design documents, validation protocols, reports, and all other supporting documents within the scope of the installation.
Feb 2014 - Jul 2014
Quality Engineer
Building Management System (BMS) upgrade at a Therapeutic Biological Manufacturing FacilityAs the Commissioning & Qualification (C&Q) representative on the Building Management System Upgrade project, responsible for ensuring all commissioning protocols were generated and executed per customer requirements. Also created the project traceability matrix.
Sep 2013 - Mar 2014
Quality Engineer
Automation Upgrade Project at a OSD Manufacturing FacilityResponsible for the generation of the project’s documentation workflow strategy, qualification, reporting, and trace matrix documents. Performed quality reviews and oversaw the progress of all V-model design documents, validation protocols, reports, and all other supporting documents within the.
Nov 2012 - Dec 2013
Process Engineer (Team Lead)
- Mixing and Filling Homogeneity Validation Project (Implementation of FDA Commitment) at a Large Manufacturer of Generic Injectables
- Co-managed a team of twenty people in the preparation of information, materials, and documentation required to complete mixing formulation validation packages for small volume and large volume injectable drugs produced.
- Responsible for technical review of validation protocols, reports, in-process data sheets, training presentations, executive summaries, and all supporting documents for multiple products within the scope of validation
- Accountable for monitoring the status of overall project progress and reporting progress updates to internal and customer management
- Responsible for overseeing the successful execution of mixing validations based on pre-approved mixing validation protocolsNNE Pharmaplan, Morrisville, NC – (Jan.’12 - Present)
- Mixing and Filling Homogeneity Validation Project (Implementation of FDA Commitment)- Validation Support (Process Engineer) (Manufacturer of Generic Injectables – Rocky Mount, NC)
Sep 2010 - Dec 2012
Project Manager
Smartflow Technologies
Responsible for managing filtration and chromatography system related projects for Biopharm and Non-regulated industriesReviewed customer submitted bid proposals to ensure project scope was properly identified, assumptions and exclusions documented, and all project system and facility related requirements were metResponsible for generating all company.
Jun 2008 - Sep 2010
Purchasing Agent
Ncsrt, Inc.
Produced and issued purchase orders for filtration system related projects, filter shop inventory, and general company needsInspected incoming quotations for compliancy with project requirements and/or specificationsScheduled and conducted vendor qualifications with new suppliersMaintained and fostered positive relationships with vendors and customers
Feb 2007 - Jun 2008
2 education records
Greg Holzer education
Bachelors, Mechanical Engineering
Virginia Tech
Bs, Mechanical Engineering
Virginia Tech
FAQ
Frequently asked questions about Greg Holzer
Quick answers generated from the profile data available on this page.
What company does Greg Holzer work for?
Greg Holzer works for Novo Nordisk.
What is Greg Holzer's role at Novo Nordisk?
Greg Holzer is listed as Validation Lead at Novo Nordisk.
What is Greg Holzer's email address?
AeroLeads has found 1 work email signal at @novonordisk.com for Greg Holzer at Novo Nordisk.
What is Greg Holzer's phone number?
AeroLeads has found 2 phone signal(s) with area code 919 for Greg Holzer at Novo Nordisk.
Where is Greg Holzer based?
Greg Holzer is based in Raleigh, North Carolina, United States while working with Novo Nordisk.
What companies has Greg Holzer worked for?
Greg Holzer has worked for Novo Nordisk, Nne, Nne Pharmaplan, Smartflow Technologies, and Ncsrt, Inc..
How can I contact Greg Holzer?
You can use AeroLeads to view verified contact signals for Greg Holzer at Novo Nordisk, including work email, phone, and LinkedIn data when available.
What schools did Greg Holzer attend?
Greg Holzer holds Bachelors, Mechanical Engineering from Virginia Tech.
What skills is Greg Holzer known for?
Greg Holzer is listed with skills including Validation, V&V, Gmp, 21 Cfr Part 11, Biotechnology, Software Documentation, Gamp, and Computer System Validation.
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