Dirk Westra
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Dirk Westra Email & Phone Number

Senior Validation Specialist at Grand River Aseptic Manufacturing
Location: Grand Rapids Metropolitan Area, United States 6 work roles 2 schools
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Role
Senior Validation Specialist
Location
Grand Rapids Metropolitan Area, United States
Company size

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Dirk Westra is listed as Senior Validation Specialist at Grand River Aseptic Manufacturing, a with 382 employees, based in Grand Rapids Metropolitan Area, United States. AeroLeads shows a matched LinkedIn profile for Dirk Westra.

Dirk Westra previously worked as CQV Engineer at Veqtor Solutions, Llc and Senior Validation Engineer at Corium Innovations. Dirk Westra holds Bachelor Of Arts - Ba, English Language And Literature, General from Calvin University.

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Grand River Aseptic Manufacturing

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Profile bio

About Dirk Westra

Organizing engineering data and solving problems with it.Highly organized validation engineer with a collaborative approach. Significant experience in all phases of equipment qualification. Known for organizing large amounts of technical data to tell the right story.CORE COMPETENCIES• Commissioning, Qualification, and Validation (CQV)• PLC Input-Output Testing• Periodic Review• Change Control • Electrical Schematics

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Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing
Senior Validation Specialist
Grand Rapids, MI, US
Employees
382
AeroLeads page
6 roles · 30 years

Dirk Westra work experience

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Cqv Engineer

Grand Rapids, Michigan, United States

Working onsite at Grand River Aseptic Manufacturing (GRAM). Commissioning and qualifying utilities: water for injection (WFI), pure steam, chilled water, heating hot water, and utility steam. Includes writing, review, and execution of risk analysis, FAT, SAT, IQ, OQ, and PQ.

Senior Validation Engineer

Grand Rapids Metropolitan Area

Wrote, reviewed, executed, and approved all phases of qualification (URS, FDS, change control, FAT, SAT, IQ, OQ, PQ, and periodic review) for GMP equipment, utilities, and facilities. Administered and monitored an environmental monitoring system (EMS). Coordinated annual calibration of 140 EMS loggers to ensure ongoing accuracy and minimal disruption of manufacturing processes.• Designed and implemented a simplified periodic review program for qualified equipment to comply with customer and regulatory requirements for qualification life cycle.• Coordinated the validation of an environmental monitoring system (EMS) software upgrade, resulting in additional user functionality and elimination of server security vulnerability.• Reduced EMS nuisance alarms by 90% by deactivating unneeded warning thresholds.• Brought fragmented calibration & PM procedures into unified format to support implementation of new calibration / PM management system.

2017 - 2023 ~6 yrs

Validation Specialist

Allegan, Michigan, United States

Performed all phases of equipment qualification for automated pharmaceutical manufacturing and packaging equipment.• Assisted in the implementation of a periodic review program for qualified equipment to comply with regulatory requirements for qualification life cycle.

2009 - 2017 ~8 yrs

Validation Engineer

Corium, International
2008 - 2009 ~1 yr

Technical Writer / Validation Engineer

Served clients in the pharmaceutical, chemical, and machine-building industries.

1997 - 2008 ~11 yrs
Team & coworkers

Colleagues at Grand River Aseptic Manufacturing

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2 education records

Dirk Westra education

Bachelor Of Arts - Ba, English Language And Literature, General

Activities and Societies: CHOIR

FAQ

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What company does Dirk Westra work for?

Dirk Westra works for Grand River Aseptic Manufacturing.

What is Dirk Westra's role at Grand River Aseptic Manufacturing?

Dirk Westra is listed as Senior Validation Specialist at Grand River Aseptic Manufacturing.

Where is Dirk Westra based?

Dirk Westra is based in Grand Rapids Metropolitan Area, United States while working with Grand River Aseptic Manufacturing.

What companies has Dirk Westra worked for?

Dirk Westra has worked for Grand River Aseptic Manufacturing, Veqtor Solutions, Llc, Corium Innovations, L Perrigo Co., and Corium, International.

Who are Dirk Westra's colleagues at Grand River Aseptic Manufacturing?

Dirk Westra's colleagues at Grand River Aseptic Manufacturing include Reese Caudy, Carrie Fortuna, Derrick Kim, Deseree Eudave, and Niyati Jackson.

How can I contact Dirk Westra?

You can use AeroLeads to view verified contact signals for Dirk Westra at Grand River Aseptic Manufacturing, including work email, phone, and LinkedIn data when available.

What schools did Dirk Westra attend?

Dirk Westra holds Bachelor Of Arts - Ba, English Language And Literature, General from Calvin University.

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