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

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

Specialist, GxP Compliance & Data Integrity

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Qua...

Location

United States , RTP, North Carolina

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience
or Master’s degree in the same fields with 8+ years of relevant experience
Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred
Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
Experience with supplier management program for computerized system suppliers
Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred
Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance

Job Responsibility

Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance

Fulltime

Business Development Manager Pharma & Biotech

Are you a sales person with passion, do you inspire customers for our innovative...

Location

Belgium , Antwerp

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Min. Bachelor’s degree in engineering, sales, marketing or related field
Experience and (basic) understanding of life sciences manufacturing practices (Automation, GAMP, CSV) would be an asset
Working experience of at least 5 years in Sales Operations or as a project engineer, lead engineer or specialist and ready for the next step
Basic understanding of Automation and/or MES PA portfolio of solutions and services
Ability to develop effective customer relationship to generate sales opportunities
Experience in customer relation management
Demonstrate a passion and genuine desire to draw insights that will lead to the development of effective sales strategies
Good communication skills with an ability to tailor messages for any audience on technical and business side
French and Dutch are required

Job Responsibility

Defining the individual approach to specific customers in order to create strong and lasting relationships and to achieve designated sales targets
Creates opportunities for the business by gathering information and keeping the business up to date
Planning and executing effective sales activities in line with the business strategy that are focused on customer satisfaction and revenue generation
Analyse the business’s sales operations information and leverages important information in the development of sales operations approaches
Develops an in-depth knowledge of the business’s core solutions through the completion of training programs and the conversion in sales activities
Works closely with operation departments, the marketing department, digital solution architects and the product development department to optimize the value selling towards the customer
Work closely with your global sales colleagues to create a growth strategy for your customers

What we offer

Exclusive compensation package: We offer a competitive salary, complemented by additional benefits
Flexible working hours: We provide flexible working hours and the option to work remotely, tailored to your professional lifestyle
Sustainable mobility solutions: You will receive a fully electric company car, including a charging card and the option for a home charging station. Additionally, charging facilities are available at our offices
Continuous professional development: Broaden your horizons with ongoing personal and professional growth opportunities, both horizontally and vertically
Fun team environment: We regularly organize team events such as Christmas parties, social quarterly drinks, sports tournaments, and more

Fulltime

New

Install Engineer, Internet Services

Internet Services (IS) is a service provider organization delivering network ser...

Location

United States , Schiller Park

Salary:

85310.00 - 110902.00 USD / Year

Encore Global

Expiration Date

Until further notice

Requirements

Bachelor of Computer Science or equivalent job experience
Preferred Certifications: Cisco CCNA/CCDA/CCNP with Wireless specialties, and other equivalent network and wireless vendors
At least 3 years of experience within the last 10 years working in a multi-network, multi-protocol Enterprise environment
3+ years of Cisco IOS and hardware experience
3 + years of experience implementing Wireless (WiFi) 802.11a/b/g/n technologies with vendors such as Cisco/Meraki, Ruckus, HP/Aruba, and Extreme Networks
Experience with Cisco ACS, Prime/WCS, Solarwinds products, or other network monitoring tools preferred
Demonstrated proficiency and experience in one or more of the following areas: Routing and Switching, Security, Wireless, Video/Voice
Strong verbal and written communication skills
Ability to analyze network performance data to identify trends and potential problems
Excellent interpersonal skills with a focus on listening and questioning

Job Responsibility

Coordinate IS project responsibilities including project organization, technical design, logistics communication, and execution
Follow and maintain design and wireless best practices and methodologies
Conduct onsite and remote technical projects such as network infrastructure surveys, designs, installations, and event engineering
Provide technical training for internal and external users
Act as technical design lead and level three support
Consult with internal and external end users on event and network requirements
Develop and implement network best-practices management and maintenance procedures
Prepare proposals for hardware, software, and professional services
Responsible for monitoring and analyzing network performance
Proactively identify and lead remediation efforts of potential network issues

What we offer

comprehensive insurance options
generous PTO
company-matching 401(k)

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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