CrawlJobs Logo
Amgen Logo Amgen · IT - Software Development

Specialist Manufacturing: Manufacturing Execution System (MES)

United States, Holly Springs Employment contract · Job Posted July 03, 2026
Apply Position
Job Link Share

Job Description

In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC's Manufacturing Support team, this position is responsible for ensuring all Electronic Batch Records accurately document the manufacturing process. It is a highly visible role across the site with the core responsibility of driving batch record optimization between the manufacturing floor and the global MES team. This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity on manufacturing floor.

Job Responsibility

  • Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
  • Ensure all Electronic Batch Records accurately document the manufacturing process
  • Drive batch record optimization between the manufacturing floor and the global MES team
  • Propose, participate, and lead team improvement initiatives to drive improved productivity on manufacturing floor
  • Coordinate with Global MES Team, Manufacturing, Process Development, Process Owner, and Quality to create and modify electronic batch records to support implementation of new products and/or technologies into the plant
  • Lead and/or participate in projects, ensuring electronic batch records accurately and effectively record all necessary process data for unit operations in Koerber PAS|X
  • Support Manufacturing in troubleshooting, problem solving and RCAs
  • Support CAPA development to prevent error recurrence
  • Own Generic Master Batch Record (GMBR) optimizations and function as primary liaison between site MES and global MES team to drive on time deliveries of GMBRs
  • Respond to regulatory questions and/or audit findings
  • Champion Lean Transformation and OE initiatives, facilitate drive towards continuous improvement in plant and track progress
  • Support batch record Standardization to enable network wide usage of generic batch records

Requirements

  • Doctorate degree OR Master's degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or Bachelor's degree and 5 years of biotechnology operations experience or Associate's degree & 10 years of biotechnology operations experience or High school diploma / GED & 12 years of biotechnology operations experience
  • Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
  • Excellent cross-functional project management, meeting facilitation, and technical writing skills
  • Experience in GMP manufacturing operations
  • Strong technical knowledge of drug substance processing (Inoculation, Bioreactors, Harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
  • Extensive experience with electronic batch record design in Koerber PAS|X or comparable software for electronic batch records with some understanding of editing and validation
  • Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
  • Ability to coach, mentor and/or cross train colleagues within core technical areas

Nice to have

  • Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
  • Excellent cross-functional project management, meeting facilitation, and technical writing skills
  • Experience in GMP manufacturing operations
  • Strong technical knowledge of drug substance processing (Inoculation, Bioreactors, Harvest, chromatography, filtration, buffer preparation)
  • Extensive experience with electronic batch record design in Koerber PAS|X or comparable software for electronic batch records with some understanding of editing and validation
  • Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
  • Ability to coach, mentor and/or cross train colleagues within core technical areas

What we offer

  • Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program or sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models including remote work arrangements where possible
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Specialist Manufacturing: Manufacturing Execution System (MES)

8 matching positions

Manufacturing Execution System (MES) Engineer / MES Software Specialist

We are seeking a skilled MES Engineer to bridge the gap between Manufacturing Op...
Location
Location
Switzerland , Hinwil
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
August 31, 2026
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Computer Science, Information Technology, Software Engineering, Industrial Engineering, Automation Engineering, or a related field
  • 3–8 years of experience in MES, Manufacturing IT, Industrial Software, or Digital Manufacturing environments
  • Experience supporting MES platforms such as Siemens Opcenter, Rockwell FactoryTalk ProductionCentre, AVEVA MES, Dassault DELMIA Apriso, SAP ME/MII, Critical Manufacturing MES, GE Proficy Plant Applications
  • Strong understanding of software development principles
  • Experience with SQL Server, Oracle, PostgreSQL, or similar databases
  • Knowledge of REST APIs, web services, and system integration technologies
  • Experience with C#, Java, .NET, JavaScript, Python, or similar programming languages
  • Familiarity with manufacturing communication protocols such as OPC UA, MQTT, and Modbus
  • Understanding of software testing, deployment, and version control processes
Job Responsibility
Job Responsibility
  • Design, configure, develop, and maintain MES applications to support manufacturing operations
  • Analyze business requirements and translate them into MES system solutions
  • Configure workflows, electronic work instructions, production routing, and quality processes within the MES platform
  • Provide ongoing application support, troubleshooting, and root-cause analysis
  • Develop and maintain integrations between MES and enterprise systems including ERP, PLM, WMS, LIMS, and SCADA
  • Collaborate with automation engineers to connect shop-floor equipment, PLCs, and IoT devices
  • Ensure reliable real-time data exchange between manufacturing and business systems
  • Support API, web services, and middleware-based integrations
  • Manage manufacturing master data, production data, and system configurations
  • Develop SQL queries, reports, dashboards, and KPIs for production monitoring
  • Fulltime
Read More
Arrow Right
New

Senior IT Specialist - Manufacturing Execution System (MES)

As the Senior IT Specialist supporting Manufacturing Execution Systems (MES), yo...
Location
Location
United States , Marion
Salary
Salary:
112000.00 - 154000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in computer science, information systems, or a related field preferred
  • 5+ years of software development experience, including hands‑on work with MES applications preferred
  • Proficiency in programming languages such as C++, C#, and Java, with strong SQL and database skills (IBM DB2 or Oracle) preferred
  • Experience installing, configuring, and maintaining MES platforms
  • familiarity with POMS, POMSnet, Siemens Opcenter Execution Medical Device (Camstar), or Opcenter Pharma (XFP) is a plus
  • Knowledge of agile and waterfall development methodologies and strong analytical and problem‑solving capabilities
  • Excellent communication and collaboration skills with experience working in manufacturing environments
  • Experience with cloud‑based MES solutions, IoT technologies, or regulated environments (FDA, ISO, GMP)
  • Proficiency in English
  • Spanish or Portuguese language skills are a plus
Job Responsibility
Job Responsibility
  • Design, develop, and maintain MES applications and supporting software systems to meet operational and compliance requirements
  • Analyze, troubleshoot, and resolve software issues to ensure optimal system performance and reliability
  • Collaborate with cross‑functional teams to deliver high‑quality MES solutions on time and in alignment with project objectives
  • Develop, maintain, and enforce coding standards and best practices, including naming conventions, documentation, error handling, and version control
  • Provide technical guidance, mentorship, and support to junior developers and team members
  • Partner with project management to define project plans, timelines, and development milestones
  • Conduct code reviews to ensure adherence to development standards and solution quality
  • Support manufacturing plants with technical expertise and issue resolution as needed
What we offer
What we offer
  • Paid Time Off
  • Employee Health & Well-Being Benefits
  • Continuing Education/ Professional Development
  • Support for Parents
  • Employee Assistance Program
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Manufacturing Execution Systems Specialist

This role is focused on design, development, validation, and continuous improvem...
Location
Location
United States , Thousand Oaks
Salary
Salary:
107545.40 - 145502.60 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree OR Master's degree and 2 years of Manufacturing Execution Systems experience OR Bachelor's degree and 4 years of Manufacturing Execution Systems experience OR Associate's degree and 8 years of Manufacturing Execution Systems experience OR High school diploma / GED and 10 years of Manufacturing Execution Systems experience
Job Responsibility
Job Responsibility
  • Design, develop, and maintain DP Manufacturing Electronic Batch Records (EBRs) using Körber PAS-X
  • Translate DP manufacturing processes / user requirement specifications into compliant MES templates, recipes, and workflows
  • Ensure EBRs and data reporting out of MES are robust, efficient, and aligned with GMP requirements
  • Support validation activities for MES / EBRs including testing and defect resolution
  • Provide day-to-day MES support to manufacturing operations, including troubleshooting and on-call support
  • Partner with NPI leads to enable MES readiness for New Product Introductions
  • Support deployment of new MES capabilities and system integrations (SAP, PI, DeltaV, Rockwell, Kepware)
  • Identify and implement improvements to MES design, usability, and performance
  • Contribute to MES standardization and best practices across the site and network
  • Support change control activities ensuring compliance with GMP procedures
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Manufacturing Specialist

Location
Location
United States , Shawnee
Salary
Salary:
Not provided
argentaglobal.com Logo
Argenta
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous experience using automated inventory system is required (i.e., SAP, MES, etc.)
  • Previous experience using motorized & non-motorized material handling equipment required
  • SAP or other Enterprise Resource Planning (ERP) experience highly desired
  • Demonstrated ability to successfully changeover/set up multiple pieces of packaging/manufacturing equipment and strong troubleshooting skills required
  • Good written and verbal communication skills in English required
  • Good PC Skills, including use of e-mail, attaching documents to e-mail required
  • Previous experience using electronic databases and on-line tools required (i.e., but not limited to, Lotus Notes database, Employee Self-Services on-line tools, etc.)
  • Experience in a government regulated, Good Manufacturing Practices (GMP) or Standard Operating Procedures (SOP) environment preferred
Job Responsibility
Job Responsibility
  • Comply with all workplace standards and safety procedures, including Lockout Tagout, Current Good Manufacturing Practices (cGMPs), Occupational Safety Health Administration requirements (OSHA), Standard Operating Procedures (SOPs), and Company Guidelines
  • Perform equipment setup and changeover activities
  • Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications
  • Perform the daily setup and routine operation of the packaging line, including, but not limited to: bottle in-feed, unscrambler, filler, bottle capper, torquer, labeler, vision systems, weighing systems, bar coding systems, sealers, disassembly/assembly, cleaning, resolving equipment stoppages and jams, and all material handling as trained
  • Perform preventive maintenance tasks as needed and trained
  • Troubleshoot Variable Frequency Drives and Servo Drive systems as trained
  • Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions
  • Palletize both finished and unfinished products and operate motorized and non-motorized material handling equipment
  • Complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), etc.
  • Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented culture
  • Fulltime
Read More
Arrow Right

QA MES Specialist

Site Name: USA - Pennsylvania - Marietta Posted Date: Apr 20 2026 Business Intr...
Location
Location
United States , Marietta
Salary
Salary:
Not provided
us.gsk.com Logo
GSK
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors degree in a technical, scientific, or quality-related field, or equivalent experience
  • 2+ years experience in quality, manufacturing, or digital systems within a regulated life sciences environment
  • Experience with MES, electronic batch records, or other manufacturing execution or electronic quality systems
  • Experience supporting change control, deviations, CAPA, or document management in a regulated environment
Job Responsibility
Job Responsibility
  • Lead MES quality activities including system configuration reviews, electronic batch record checks, and system change control support
  • Review MES-generated records and reports to confirm completeness, data integrity, and compliance with procedures
  • Support investigations of deviations linked to MES or digital systems. Perform root cause analysis and track corrective actions
  • Partner with validation and IT to ensure MES changes link to DQ/IQ/OQ/PQ or equivalent validation steps and documentation
  • Coach manufacturing and lab teams on good documentation practices, electronic record keeping, and system use on the shop floor
  • Maintain inspection-ready MES records and contribute to quality KPI trending and continuous improvement initiatives
  • Support readiness for internal and external audits, provide clear documentation and act as a subject matter contributor during inspections
  • Manage supplier and third-party quality expectations for MES vendors and integrators, ensuring timely resolution of issues
What we offer
What we offer
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Fulltime
Read More
Arrow Right

Manufacturing Specialist Sterile Fill

Perform operations in a line team environment to provide high quality pharmaceut...
Location
Location
United States , Shawnee, Kansas
Salary
Salary:
Not provided
argentaglobal.com Logo
Argenta
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma or GED
  • 2 years manufacturing experience
  • Previous experience using automated inventory systems
  • Previous experience using motorized & non-motorized material handling equipment
  • Demonstrated ability to successfully changeover/set up multiple pieces of packaging/manufacturing equipment and strong troubleshooting skills
  • Good written and verbal communication skills in English
  • Good PC Skills, including use of e-mail, attaching documents to e-mail
  • Previous experience using electronic databases and on-line tools
  • Demonstrate ability to work safely in a production environment
  • Ability to read/interpret/follow instructions regarding workplace documentation
Job Responsibility
Job Responsibility
  • Comply with all workplace standards and safety procedures, including Lockout Tagout, Current Good Manufacturing Practices (cGMPs), Occupational Safety and Health Administration requirements (OSHA), Standard Operating Procedures (SOPs), and Company Guidelines
  • Perform equipment setup and changeover activities
  • Act to safely reduce equipment setup and changeover times
  • Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications
  • Meet line Operational Asset Effectiveness requirements per area targets
  • Escalate downtime properly
  • Perform the daily setup and routine operation of the packaging line, including but not limited to bottle in-feed, unscrambler, filler, bottle capper, torquer, labeler, vision systems, weighing systems, bar coding systems, sealers, disassembly/assembly, cleaning, resolving equipment stoppages and jams, and all material handling as trained
  • Perform preventive maintenance tasks as needed and trained
  • Troubleshoot Variable Frequency Drives and Servo Drive systems as trained
  • Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions
  • Fulltime
Read More
Arrow Right

Manufacturing Systems Specialist

We're looking for people who embody our values who aren't afraid to challenge, i...
Location
Location
Mexico , Ecatepec
Salary
Salary:
Not provided
essity.it Logo
ESSITY ITALY S.P.A.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Electrical, Control, Robotic, Mechanical, Electronics Engineering, or related field
  • Minimum 2 years of experience in manufacturing environments / manufacturing systems
  • Change‑management capability
  • Manufacturing Execution Systems (MES - ERP) ISA 95 Level3
  • OPC Server/Client / TSDB
  • PLC and SQL
  • Strong accountability, ownership and collaboration skills
  • Analytical mindset and problem‑solving
  • Effective communication with multidisciplinary teams
  • English C1
Job Responsibility
Job Responsibility
  • Ensure the reliability, performance, and continuous improvement of manufacturing digital systems across the mill
  • Serve as the primary bridge between IT-OT, and Operations
  • Ensure accurate delivery of OEE
  • Serve as a key connection point between IT and mill operations
  • Collaborate with cross functional teams (Operations - IT - Quality - Finance - Planning)
  • Deliver timely assistance to internal users through incident resolution, requirement management, and clear communication
  • Bridge theory and technology with on‑the‑floor execution to deliver measurable value in the mill
What we offer
What we offer
  • People-first approach
  • Collaborative and open atmosphere
  • Opportunity to innovate for good
  • Empowered to grow
  • Sustainable work-life based on flexibility
  • Commitment to Diversity, Equity, and Inclusion
  • Fulltime
Read More
Arrow Right

Csv Specialist / Csv Consultant - Mes Validation

Location
Location
India , Hyderabad
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience in Computer System Validation (CSV)
  • 3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
  • 3+ years of hands-on experience with MES validation and GxP validation lifecycle
  • Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
  • Experience in validation document preparation, review, execution, and approval workflows
  • Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
  • Strong documentation discipline and attention to detail
Job Responsibility
Job Responsibility
  • Validation Plan and Validation Risk Assessment
  • Requirement Traceability Matrix
  • IQ, OQ, and PQ protocols
  • Executed test scripts with objective evidence
  • Deviation, defect, and issue logs with closure evidence
  • Validation Summary Report
  • Approved validation package supporting MES go-live readiness
  • Fulltime
Read More
Arrow Right