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Head of Software
Tacit
San Francisco, CA
- $200,000 to $300,000 USD / year
We are hiring a Head of Software Engineering to lead and scale a highly technical software organization spanning consumer applications, real-time inference systems, cloud infrastructure,…
Added 6 mins ago
Chief Expert Robotics
Bosch Group
Sunnyvale, CA
Drive End-to-End Robotics Deployment: As a Chief Expert Robotics, you will lead the technical implementation and architecture of advanced robotic systems by translating complex algorithms…
Added 6 mins ago
Chief Expert Robotics
Bosch Group
Pittsburgh, PA
Drive End-to-End Robotics Deployment: As a Chief Expert Robotics, you will lead the technical implementation and architecture of advanced robotic systems by translating complex algorithms…
Added 6 mins ago
Data Center Specialist (Xin001_HW2T)
Xinnovit
San Jose, CA
5 years of experience, working in Data Center Operations with one or more of the following: network, distributed systems, mainframe, midrange, batch.
Added 7 mins ago
Senior Software Engineer
Workila
Washington, DC
…the application and mapping client business requirements to systems/technical…
Added 7 mins ago
Jr and Sr Java Developers
Veredus - DC
Alexandria, VA
EXPERIENCE REQUIRED: • Must be a US Citizen and capable of obtaining an IT-II clearance. • Bachelors Degree (computer science, information systems major preferred). • 6+ years of hands-on…
Added 7 mins ago
Web Developer
Veredus - DC
Vienna, VA
…demand now and who will be next. Your Veredus Recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and desires. They also…
Added 7 mins ago
V-
SQL DBA
Veredus - DC
Alexandria, VA
- $45 USD / hour
…demand now and who will be next. Your Veredus Recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and desires. They also…
Added 7 mins ago
Senior Project Manager - Demandware
Workila
Phoenix, AZ
Is your passion to lead technical programs that deliver customer-focused solutions that are the engine of merchandising, finance, CRM or Online/Mobile experiences? Do you love pets and want…
Added 7 mins ago
Instrumentation Engineer
WinMax Systems Corporation
Santa Clara, CA
Understanding of computer architecture, hardware, firmware, operating systems, and user applications, and the interactions between them
Added 7 mins ago
GOT JAVA OPENINGS FOR Jr. and Sr. Java Developers supporting a DoD contract
Veredus - DC
Alexandria, VA
EXPERIENCE REQUIRED: • Must be a US Citizen and capable of obtaining an IT-II clearance. • Bachelors Degree (computer science, information systems major preferred). • 6+ years of hands-on…
Added 7 mins ago
Sr. SalesForce Project Manager
Veredus - DC
Alexandria, VA
…limitations and can clearly communicate those to customers. Lead discovery workshops, which includes the facilitation of large audiences, solution presentations, and prototype…
Added 7 mins ago
Intermediate/Senior/Lead Business Systems Analyst (EBS)-150001TS
Right Talent Right Now
San Antonio, TX
Intermediate/Senior/Lead Business Systems Analyst
Added 7 mins ago
Quality Control Microbiologist
Us tech Solutions
Myerstown, PA
This position is in the Quality Assurance department and the incumbent will be expected to continuously learn Quality Assurance systems, manufacturing, and effectively engage in…
Added 7 mins ago
Senior Manager Quality Engineer (Medical Devices and Pharma Experience required)
Validation & Engineering Group
Rhode Island, RI
Accountable to provide Quality oversight of FP Technologies method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality…
Added 7 mins ago
MES Engineer
Validation & Engineering Group
Morrisville, NC
Senior Computer System Validation (CSV) Specialist - with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. The role…
Added 7 mins ago
Quality control chemist
Us tech Solutions
Myerstown, PA
…previous analytical experience, as well as continuously learn Quality Control systems and effectively engage in relationships with peers in the laboratories, Manufacturing/Production, and…
Added 7 mins ago
Software Engineer
Trialon Corporation
Auburn Hills, MI
Lead the development, integration, testing and maintenance high quality automotive software for a power systems ECU including hybrid and electric vehicle products.
Added 8 mins ago
Software Engineer
Transactive
Philadelphia, PA
Perform tests on software modules and complete systems. Develop Regression and Acceptance tests plans and generates bug reports. Provide software quality assurance (QA) function.
Added 8 mins ago
SG
Pre-Analytical Assistant I
Synergy Global Systems
10200 Commerce Pkwy, FL
- $15 USD / hour
…together and how they impact Technical departments and result…
Added 8 mins ago
Intermediate/Senior/Lead Business Systems Analyst (EBS)-150001TS
Right Talent Right Now
Memphis, TN
Intermediate/Senior/Lead Business Systems Analyst
Added 8 mins ago
Intermediate/Senior/Lead Business Systems Analyst (EBS)-150001TS
Right Talent Right Now
Raleigh, NC
Intermediate/Senior/Lead Business Systems Analyst
Added 8 mins ago
Intermediate/Senior/Lead Business Systems Analyst (EBS)-150001TS
Right Talent Right Now
Baltimore, MD
Intermediate/Senior/Lead Business Systems Analyst
Added 8 mins ago
Intermediate/Senior/Lead Business Systems Analyst (EBS)-150001TS
Right Talent Right Now
Atlanta, GA
Intermediate/Senior/Lead Business Systems Analyst
Added 8 mins ago
Intermediate/Senior/Lead Business Systems Analyst (EBS)-150001TS
Right Talent Right Now
Cleveland, OH
Intermediate/Senior/Lead Business Systems Analyst

Validation & Engineering Group

MES Engineer

Morrisville, NC, United States

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Job details

Experience: 7–10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing.
Posting language: English
Posted: Sep 30, 2025

Original job description

Company Description 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.

Job Description

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.

Additional Information All your information will be kept confidential according to EEO guidelines.

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More about this job

Skills

MES
Regulatory compliance
Good manufacturing practices
Documentation
ICT system integration
LIMS
ERP
SAP
Inspection
Process improvement
Computer science
Pharmaceutical processes
Manufacturing processes
DCS
Technical writing
Communication skills
Leadership
Problem solving
Quality assurance procedures

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