LL01-250919 Manufacturing Execution Systems Validation Specialist
3 weeks ago
Career Opportunities with Validation & Engineering Group
A great place to work.
Current job opportunities are posted here as they become available.
LL01-250919 Manufacturing Execution Systems Validation Specialist (NC)
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Senior Computer System Validation (CSV) Specialist - with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle.
Key Responsibilities
- Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment.
- Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports.
- Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant.
- Perform impact assessments and change control for system upgrades, patches, and enhancements.
- Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations.
- Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian).
- Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits.
- Mentor junior validation engineers and support knowledge transfer on CSV best practices.
- Contribute to continuous improvement of MES validation strategies, procedures, and templates.
Qualifications
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred.
- 7–10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing.
- Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records).
- Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5.
- Experience in biologics manufacturing processes (cell culture, purification, fill/finish).
- Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians).
- Excellent technical writing and documentation skills.
- Strong communication, leadership, and problem-solving abilities.
Preferred Skills
- Experience in large-scale biotech/biologics start-up or tech transfer projects.
- Knowledge of data integrity principles and ALCOA+ requirements.
- Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat).
- Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches.
#J-18808-Ljbffr
-
Morrisville, Canada Veg Group Full timeCareer Opportunities with Validation & Engineering GroupA great place to work.Current job opportunities are posted here as they become available.LL01-250919 Manufacturing Execution Systems Validation Specialist (NC)Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology,...
-
Regulatory Specialist
3 weeks ago
Morrisville, Canada Nufarm Limited Full timeCareer Opportunities: Regulatory Specialist (9860) Are you passionate about regulatory affairs and compliance? Do you thrive in a collaborative environment where precision, purpose, and innovation come together to support growers? This opportunity at Nufarm could be your perfect fit. Regulatory Specialist Morrisville, NC | Full-time | Nufarm Americas...
-
Senior Outside Sales Account Executive
1 week ago
Morrisville, Canada Toshiba America Business Solutions Full timeFirst year potential total compensation is $75,000.00. Base: $38,000.00 to $40,000.00 depending on experience First-year on-track earnings at 100%, including base, commission, bonus, and expense allowance of $75,000 (approximate). Toshiba America Business Solutions, a leader in digital technology. Our people bring creative, real-world solutions for our...
-
Senior Outside Sales Account Executive
5 days ago
Morrisville, Canada Toshiba America Business Solutions Full timeFirst year potential total compensation is $75,000.00. - Base: $38,000.00 to $40,000.00 depending on experience - First-year on-track earnings at 100%, including base, commission, bonus, and expense allowance of $75,000 (approximate). Toshiba America Business Solutions, a leader in digital technology. Our people bring creative, real-world solutions for our...
-
Contract Facilities Manager
1 week ago
Morrisville, Canada Encoded Therapeutics Full timeThe Facilities Manager is an organized, flexible, and detail-oriented person who is enthusiastic for both the practical and creative elements of facilities management. Our North Carolina operations are growing rapidly, and we’ll need our Facilities Manager for scaling programs, strengthening vendor relationships, and helping to keep our operations...
-
Contract Facilities Manager
1 week ago
Morrisville, Canada Encoded Therapeutics Full timeThe Facilities Manager is an organized, flexible, and detail-oriented person who is enthusiastic for both the practical and creative elements of facilities management. Our North Carolina operations are growing rapidly, and we’ll need our Facilities Manager for scaling programs, strengthening vendor relationships, and helping to keep our operations...
-
Digital Transformation Process Design Analyst
4 weeks ago
Morrisville, Canada Lenovo Full timeUnited States of America - North Carolina - Morrisville Why Work at Lenovo We are Lenovo. We do what we say. We own what we do. We WOW our customers. Lenovo is a US$69 billion revenue global technology powerhouse, ranked #196 in the Fortune Global 500, and serving millions of customers every day in 180 markets. Focused on a bold vision to deliver Smarter...
-
Remote IT Operations Engineer
4 weeks ago
Morrisville, Canada Lenovo Full time* United States of America - North Carolina - Morrisville Why Work at Lenovo We are Lenovo. We do what we say. We own what we do. We WOW our customers. Lenovo is a US$69 billion revenue global technology powerhouse, ranked #196 in the Fortune Global 500, and serving millions of customers every day in 180 markets. Focused on a bold vision to deliver...
-
Remote IT Operations Engineer
4 weeks ago
Morrisville, Canada Lenovo Full time* United States of America - North Carolina - Morrisville Why Work at Lenovo We are Lenovo. We do what we say. We own what we do. We WOW our customers. Lenovo is a US$69 billion revenue global technology powerhouse, ranked #196 in the Fortune Global 500, and serving millions of customers every day in 180 markets. Focused on a bold vision to deliver Smarter...
-
Morrisville, Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Halton Hills, Victoria, Surrey, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southweste, Canada Lenovo Full time* United States of America - North Carolina - Morrisville Why Work at Lenovo We are Lenovo. We do what we say. We own what we do. We WOW our customers. Lenovo is a US$69 billion revenue global technology powerhouse, ranked #196 in the Fortune Global 500, and serving millions of customers every day in 180 markets. Focused on a bold vision to deliver Smarter...
