Senior Process Engineer, Purification
Jul 2020 - Jul 2024
AeroLeads people directory · profile
Stephen Winstead, Cssgb Email & Phone Number
Sr. Process Engineer at Merck Specializing Lean manufacturing, Pharmaceutical Manufacturing, and Fermentation Plant Startups
1 work email found
@alfalaval.com
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 86%
Role
Sr. Process Engineer at Merck Specializing Lean manufacturing, Pharmaceutical Manufacturing, and Fermentation Plant Startups
Location
Stem, North Carolina, United States
Who is Stephen Winstead, Cssgb? Overview
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Quick answer
Stephen Winstead, Cssgb is listed as Sr. Process Engineer at Merck Specializing Lean manufacturing, Pharmaceutical Manufacturing, and Fermentation Plant Startups based in Stem, North Carolina, United States. AeroLeads shows a work email signal at alfalaval.com and a matched LinkedIn profile for Stephen Winstead, Cssgb.
Stephen Winstead, Cssgb previously worked as Senior Process Engineer, Purification at Merck and Manufacturing Engineer at Alfa Laval. Stephen Winstead, Cssgb holds B.S., Biology from University Of Massachusetts Lowell.
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Email format at alfalaval.com
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*@alfalaval.com
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Profile bio
About Stephen Winstead, Cssgb
• Six Sigma Green Belt Certified with 10 years of process optimization, TQM, SPC experience.• >10 years of intensive compliance, quality, and manufacturing program design including extensive SOP, SPC, and other document authoring.• SAP super user (manufacturing execution).• >10 years of process optimization, validation, and process engineering experience.• 10 years of industrial and pharmaceutical microbiology experience• 10 years of experience in quality department and production operations and optimization.• 4 years of production management in pharmaceutical plants overseeing manufacturing, purification, and sterile filling (bulk and retail packages) of drug products.• 6 years experience in fermentation (bacterial & yeast)• 7 years of management experience as a lab supervisor and quality department manager with up to 8 direct reports and 40 indirect reports.• Ground-up 3D design and construction using Solidworks.Specialties: Championing safety in all formsCertified Six Sigma Green BeltProcess Optimization, TQM, Management of aseptic drug manufacturing and sterile fillingEquipment and process validation and implementation.Fermentation plant startupMicrobiology lab construction and validation, Microbiology R&D, cGMP compliance (21 CFR 210, 211), Environmental monitoring, Pharmaceutical microbiology, Industrial microbiology, Ethanol fermentation, Bacterial fermentation & cell culture, SPC, TQM,MS Access, Excel, Word, SAP, LIMSWet Chemistry (HPLC, GC, KF, IC, etc.)Technical writingAseptic design
Listed skills include Validation, Gmp, Hplc, Lims, and 14 others.
10 roles
Stephen Winstead, Cssgb work experience
A career timeline built from the work history available for this profile.
Manufacturing Engineer
Jan 2019 - Jul 2020
Process Engineer
Nov 2015 - Jan 2019
Quality Engineer Then Production Supervisor
Pfizer / Zoetis
I was hired by Pfizer as a quality engineer to assist with the optimization of the manufacturing process for their Prevnar vaccine line in anticipation of the technology transfer to their production facility in Grange Castle, Ireland at the end of FY2012.In October, 2012 I was promoted to production supervisor for Shift-B of the Prevnar division.
Oct 2011 - Nov 2015
Quality Manager (Out Of Business)
Clean Burn Fuels, Llc
- I was the quality manager at Clean Burn Fuels, in Raeford, NC. CBF is North Carolina's first corn to ethanol plant and is a 60M gal/yr Katzen designed plant that began operation in September, 2010 but idled operations.
- Spec'd, ordered, setup, and validated all of the lab equipment
- Wrote and validated all SOP's and quality programs
- Built the quality department within the corporate structure
- Hired, trained and managed all laboratory technicians on an ongoing basis.
- Trained and supervised 40 process operators in quality operations and the use of the lab equipment
Nov 2009 - May 2011
Microbiology Lab Supervisor
I was the microbiology lab supervisor for ADM Polymer in Clinton, IA. I was responsible for starting up the micro lab, validating all of the equipment, designing plant sterility validations, starting fermentations, aseptic training of all personnel, lab technician management, designing and implementing lab management programs for regulatory compliance.
Jul 2008 - Nov 2009
Quality Manager
Ohio Ethanol, Llc (Out Of Business)
Plant Startup #2 - Out of business; I was employed by Greater Ohio Ethanol to create and manage the quality department and quality control lab, including all associated procedures, policies, budgets, and structure within the corporation. Greater Ohio Ethanol was a startup 54 MM gallon/yr dry-mill ethanol plant. The plant began manufacturing operations in.
Jan 2008 - Jul 2008
Microbiology & Phage Lab Supervisor, Fermentation Microbiologist
Dupont, Tate & Lyle Bioproducts
Aug 2005 - Dec 2007
Quality Control Microbiologist Ii
Millipore, Inc
Apr 2003 - May 2005
Contract Lab Technician
Staffing Agencies Around Boston, Ma
After graduating from college in 2001 I started my career as a contract lab technician working in microbiology and quality laboratories in cGMP compliant pharmaceutical manufacturing and research companies around the greater-Boston area. The companies I was a contractor at included Bristol Myers Squibb, Charles River Labs, Macrochem, and Eisai Research.
May 2001 - Apr 2003
3 education records
Stephen Winstead, Cssgb education
B.S., Biology
University Of Massachusetts Lowell
Lean Manufacturing Certification
University Of Michigan
Six Sigma Green Belt Certification
Zoetis / Univ. Of Ne
FAQ
Frequently asked questions about Stephen Winstead, Cssgb
Quick answers generated from the profile data available on this page.
What is Stephen Winstead, Cssgb's role at their current company?
Stephen Winstead, Cssgb is listed as Sr. Process Engineer at Merck Specializing Lean manufacturing, Pharmaceutical Manufacturing, and Fermentation Plant Startups.
What is Stephen Winstead, Cssgb's email address?
AeroLeads has found 1 work email signal at @alfalaval.com for Stephen Winstead, Cssgb.
Where is Stephen Winstead, Cssgb based?
Stephen Winstead, Cssgb is based in Stem, North Carolina, United States.
What companies has Stephen Winstead, Cssgb worked for?
Stephen Winstead, Cssgb has worked for Merck, Alfa Laval, Novipax, Pfizer / Zoetis, and Clean Burn Fuels, Llc.
How can I contact Stephen Winstead, Cssgb?
You can use AeroLeads to view verified contact signals for Stephen Winstead, Cssgb, including work email, phone, and LinkedIn data when available.
What schools did Stephen Winstead, Cssgb attend?
Stephen Winstead, Cssgb holds B.S., Biology from University Of Massachusetts Lowell.
What skills is Stephen Winstead, Cssgb known for?
Stephen Winstead, Cssgb is listed with skills including Validation, Gmp, Hplc, Lims, Microbiology, V&V, Gas Chromatography, and Technology Transfer.
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