Life sciences MES Engineer Job at Sopra Steria (Machelen)

Life sciences quality and compliance engineer

As a Quality & Compliance Engineer, you will ensure that products, processes, sy...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Graduate with a Master's degree in a scientific direction (Industrial Ir, Bio Ir, Chemie, Biotechnology, Pharmacy,...) or equivalent by experience
Experienced in working in a regulated environment, with developed document writing skills
You demonstrate the consultancy mindset by being pro-active, taking ownership and showing commitment
Problem solving mindset and eager to learn and evolve
You have a strong sense of responsibility and an eye for quality
You will contribute to projects for top companies, both nationally and internationally
Teamplayer with the ability to go in full focus-mode when independent work is required

Job Responsibility

Ensure that products, processes, systems and services in the world of Life Sciences meet regional and global quality regulations and standards
Active in various areas such as computer system validation (CSV), MES, lab qualification, Quality Assurance, Engineering

What we offer

Mobility options (including a company car)
Insurance coverage
Meal vouchers
Eco-cheques
Continuous learning opportunities through the Sopra Steria Academy
Opportunity to connect with fellow Sopra Steria colleagues at various team events

MES Designer

Are you a motivated Systems Engineer with Manufacturing Execution Systems (MES) ...

Location

Ireland , Cork; Dublin

Salary:

Not provided

Accenture

Expiration Date

Until further notice

Requirements

Motivated Systems Engineer with Manufacturing Execution Systems (MES) experience within the Life Science, Pharmaceutical or Biotech industry
Passionate about driving forward innovation in manufacturing excellence, and helping leading organizations to move towards Manufacturing and Factory Digitalization
Ambitious Manufacturing Execution Systems Engineers with hands-on MES design experience ready to take on new challenges

Job Responsibility

Partner with technical leads and clients to support the design, development, documentation, and implementation of Manufacturing Execution Systems (MES) for a growing client base
Collaborate with business clients and internal teams to determine appropriate solutions and deliver on multiple large-scale projects
Work collaboratively with business users to define the needs and design solutions that add value
Gather user requirements in relation to controlling and recording manufacturing activities
Design, author, develop and configure Electronic Batch Records (EBR)
Implement MES solutions and integrate with ERP and control equipment
Document MES configuration and validation of EBRs

Fulltime

Pharmaceutical Business Analyst

Are you a detail-oriented professional with strong analytical skills and a passi...

Location

Canada , Toronto

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business, Life Sciences, Engineering, or related field
Proven experience as a Business Analyst in the pharmaceutical or biotech industry
Strong understanding of GxP, regulatory compliance, and pharmaceutical manufacturing processes
Experience working with ERP, MES, LIMS, or other life sciences digital systems
Excellent communication, documentation, and stakeholder management skills
Ability to work independently and collaboratively in a fast-paced environment

Job Responsibility

Gather, analyze, and document business requirements from stakeholders across departments
Translate business needs into functional specifications and user stories
Collaborate with cross-functional teams including IT, QA, Manufacturing, and Regulatory Affairs
Support system implementation and process improvement initiatives
Perform gap analysis and recommend solutions to enhance operational efficiency
Assist in validation documentation and ensure compliance with industry regulations (GxP, FDA, EMA)

What we offer

An international community bringing together more than 110 different nationalities
An environment where trust is central: 70% of our leaders started their careers at the entry level
A strong training system with our internal Academy and more than 250 modules available
A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Fulltime

MES Consultant – AspenTech MES (Pharmaceutical Manufacturing)

Join our Life Sciences team as a MES Consultant specializing in AspenTech MES fo...

Location

Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Computer Science, Engineering, Information Systems, Life Sciences, or related disciplines
5+ years of experience in MES implementations, preferably with AspenTech MES or similar platforms (e.g., Rockwell PharmaSuite, Werum PAS-X, Siemens Opcenter)
Solid experience with Aspen MES configuration and integration
Familiarity with pharmaceutical batch process automation and data integrity requirements
Knowledge of industry regulations and practices: GxP, 21 CFR Part 11, Annex 11
Strong analytical and problem-solving capabilities
Effective communication with both technical and non-technical stakeholders
Proactive, self-driven, and able to work in a fast-paced, client-facing environment
Team-oriented, with a commitment to quality and continuous improvement

Job Responsibility

Support the deployment, configuration, and optimization of AspenTech MES in pharmaceutical manufacturing settings
Collaborate with clients to translate operational needs and regulatory requirements into AspenTech MES solutions
Design, configure, and test Aspen MES components to align with GxP compliance and manufacturing workflows
Provide input on system architecture, batch execution models, and integration requirements
Troubleshoot Aspen MES application and integration issues
support root cause analysis and system improvements
Participate in the design and development of electronic batch records (EBRs) within Aspen MES
Support validation lifecycle activities (IQ, OQ, PQ) in compliance with FDA 21 CFR Part 11 and GMP
Deliver on-site and remote support during MES deployment, commissioning, and post-Go Live optimization

What we offer

Global Diversity: Be part of an international team of 110+ nationalities
Trust and Growth: 70% of our leaders starting at entry-level
Continuous Learning: internal Academy and over 250 training modules
Vibrant Culture: afterworks, networking events
Meaningful Impact: CSR initiatives, including the WeCare Together program

Fulltime

Senior MES Engineer

We are seeking a Senior MES Engineer to support the expansion of our Manufacturi...

Location

United States , Raleigh

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, Information Systems, or a related technical discipline
7+ years of experience supporting or implementing MES solutions in pharmaceutical, biotech, or life sciences manufacturing environments
Strong knowledge of GMP regulations, data integrity principles, and validated systems
Hands-on experience with one or more MES platforms (e.g., Emerson Syncade, Rockwell PharmaSuite, Körber PAS-X, or similar)
Experience with MES configuration, integration, and support across manufacturing operations
Strong troubleshooting, analytical, and problem-solving skills
Ability to work effectively in an on-site, client-facing role
Excellent written and verbal communication skills

Job Responsibility

Provide on-site and remote MES engineering support for pharmaceutical manufacturing operations
Lead the design, configuration, and deployment of MES solutions in GMP-regulated environments
Serve as a technical subject matter expert for MES platforms, supporting production, quality, and IT stakeholders
Support MES lifecycle activities including requirements gathering, system configuration, testing, validation, deployment, and operational support
Lead or contribute to change management, impact assessments, and controlled system updates
Support investigations, root cause analysis, and issue resolution related to MES applications
Lead, mentor, and grow a team of MES engineers, providing hands-on technical guidance, career development support, and day-to-day leadership to build a strong and scalable MES practice
Drive the continued growth of the MES practice by defining standards, establishing best practices, and providing technical leadership to ensure consistent, high-quality MES solution delivery
Contribute to the growth of the MES practice through standardization, best practices, and technical leadership
Collaborate closely with Sales and Business Development to support pre-sales activities, shape MES solutions, and identify new opportunities that expand the MES practice and overall business

New

Senior Automation Engineer

The Senior Automation Engineer provides subject matter expertise in the design, ...

Location

United States , Springfield; Atlanta; Austin; Boston; Columbus; Denver; Harrisburg; Indianapolis; Jefferson City; Raleigh; Richmond

Salary:

130000.00 - 165000.00 USD / Year

PerkinElmer

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related)
Minimum 9-12+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP)
Expert-level experience with DeltaV DCS and/or Rockwell / Allen Bradley PLC/SCADA platforms
Proven ability to author, interpret, and own URS/FRS/DS documentation
Experience designing system architectures across DCS, PLCs, SCADA, MES, OSI-PI and/or other historians and data systems
Strong understanding of ISA‑88 batch control, ISA‑95 manufacturing hierarchy, and GAMP 5
Hands‑on experience supporting biologics and sterile/aseptic manufacturing environments
Understanding multisite standards for global manufacturers
Applicants must be authorized to work in the United States on a full-time basis
We cannot employ anyone with an invalid driver's license

Job Responsibility

Develop full automation system architectures for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers, field instrumentation)
Create ISA‑88/ISA‑95‑aligned architecture diagrams, I/O strategies, network topologies, and interface specifications
Ensure architecture supports scalability, cybersecurity, data integrity, and multi‑product flexibility
Lead the creation, review, and approval of: URS (User Requirements Specifications), FRS (Functional Requirements Specifications), DS / DDS (Design Specifications), Functional & Control Narratives, Recipe Design Documentation (ISA‑88 compliant), Automation Standards & Engineering Guidelines
Work cross functionally to translate process requirements into robust automation design documents
Configure, program, and deploy DeltaV DCS (modules, phases, recipes, batch strategies, graphics, alarms)
Develop, modify, and test Rockwell PLCs (ControlLogix, CompactLogix), FactoryTalk, PlantPAx, and SCADA/HMI applications
Support integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment
Detailed knowledge of FAT, SAT, IQ/OQ, and PQ protocols in alignment with GAMP 5 and 21 CFR Part 11
Ensure automation changes meet data integrity requirements, change control processes, and validation lifecycle rules

Fulltime

Senior Automation Engineer

The Senior Automation Engineer provides subject matter expertise in the design, ...

Location

United States , Springfield; Atlanta; Austin; Boston; Columbus; Denver; Harrisburg; Indianapolis; Jefferson City; Raleigh; Richmond

Salary:

130000.00 - 165000.00 USD / Year

PerkinElmer

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related)
Minimum 9-12+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP)
Expert-level experience with DeltaV DCS and/or Rockwell / Allen Bradley PLC/SCADA platforms
Proven ability to author, interpret, and own URS/FRS/DS documentation
Experience designing system architectures across DCS, PLCs, SCADA, MES, OSI-PI and/or other historians and data systems
Strong understanding of ISA‑88 batch control, ISA‑95 manufacturing hierarchy, and GAMP 5
Hands‑on experience supporting biologics and sterile/aseptic manufacturing environments
Understanding multisite standards for global manufacturers
Applicants must be authorized to work in the United States on a full-time basis
We cannot employ anyone with an invalid driver's license

Job Responsibility

Develop full automation system architectures for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers, field instrumentation)
Create ISA‑88/ISA‑95‑aligned architecture diagrams, I/O strategies, network topologies, and interface specifications
Ensure architecture supports scalability, cybersecurity, data integrity, and multi‑product flexibility
Lead the creation, review, and approval of: URS (User Requirements Specifications), FRS (Functional Requirements Specifications), DS / DDS (Design Specifications), Functional & Control Narratives, Recipe Design Documentation (ISA‑88 compliant), Automation Standards & Engineering Guidelines
Work cross functionally to translate process requirements into robust automation design documents
Configure, program, and deploy DeltaV DCS (modules, phases, recipes, batch strategies, graphics, alarms)
Develop, modify, and test Rockwell PLCs (ControlLogix, CompactLogix), FactoryTalk, PlantPAx, and SCADA/HMI applications
Support integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment
Detailed knowledge of FAT, SAT, IQ/OQ, and PQ protocols in alignment with GAMP 5 and 21 CFR Part 11
Ensure automation changes meet data integrity requirements, change control processes, and validation lifecycle rules

Fulltime

CSA & Quality Compliance Expert

The CSA & Quality Compliance Expert will support compliance and validation proje...

Location

Italy , Milan

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry, etc.)
At least 3-5 years of experience in CSA activities within Life Science
Solid understanding of regulatory guidelines: GAMP 5, FDA 21 CFR Part 11, EU Annex 11
Experience with risk-based validation approaches and familiarity with software validation in GxP contexts
Ability to manage complex projects and effectively collaborate with clients across multiple industries
Excellent analytical, planning, and problem-solving skills
Proficiency in English, both written and spoken

Job Responsibility

Draft and review validation documentation in compliance with industry regulations
Participate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA, and Data Integrity solutions
Support compliance projects in the Medical Device sector, ensuring adherence to ISO 13485, EU MDR, and other relevant regulations
Perform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments
Collaborate with cross-functional teams, including IT, QA, and operations, to ensure compliance with standards and regulations
Provide support during client and regulatory audits (FDA, EMA, ISO, etc.), supplying evidence and required documentation
Deliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors

Fulltime

Life sciences MES Engineer

Sopra Steria

Location:
Belgium , Machelen

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 25, 2025

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