Life sciences quality and compliance engineer Job at Sopra Steria (Machelen)

Life sciences Computer System Validation Engineer

As a quality and compliance expert, you will be responsible for ensuring that Gx...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Proven CSV experience in multiple projects or strong interest in CSV
Strong affinity with IT
Analytical and pragmatic thinking skills
Strong prioritization and planning skills
Strong sense of responsibility and accountability
A positive, solution-driven mindset
Excellent written and oral communication skills in Dutch and English
Basic knowledge of IT infrastructure qualification
A team player, but also able to work independently
Familiar with applicable regulatory standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,...

Job Responsibility

Ensure that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle
Stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO
Provide Quality & Compliance support during audits and inspections
Join a Sopra Steria validation service team
Ensure the quality and regulatory compliance of GxP systems throughout their entire life cycle and across all GxP areas (GLP, GCP, GMP, GDP, GPvP)

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

Young Professional Life Sciences

Sopra Steria offers tailored, end-to-end corporate technology and software solut...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Educational Background: A degree in Life Sciences, Engineering, Pharmacy, or a related field
Knowledge of Validation and Qualification: Basic understanding of validation and qualification processes in the pharmaceutical industry is a plus
Technical Skills: Familiarity with Good Manufacturing Practices (GMP), regulatory guidelines, and industry standards
Analytical Skills: Ability to analyze data, identify trends, and draw meaningful conclusions
Problem-Solving: Skill in quickly resolving technical issues
Flexibility: Ability to adapt to changing environments and handle multiple tasks simultaneously
Stress Management: Capable of maintaining composure and effectiveness under pressure
Professionalism: Demonstrates a high level of professionalism in all interactions and tasks
Social Skills: Strong interpersonal skills, able to build and maintain positive relationships with colleagues and clients
Communication Skills: Excellent verbal and written communication skills, able to convey complex information clearly and concisely

Job Responsibility

Audits are conducted regularly to keep our standards high while adhering to strict quality control guidelines.

What we offer

Mobility options (including a company car)
insurance coverage
meal vouchers
eco-cheques
continuous learning opportunities through the Sopra Steria Academy
the opportunity to connect with colleagues at team events.

New

GMP Engineering Compliance Specialist

We are seeking an Engineering Compliance Specialist to support engineering syste...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Life Sciences, or related field
Experience in pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments
Hands-on or review experience in engineering system checks, asset review, maintenance risk assessments, or calibration activities
Good understanding of GMP documentation practices and engineering compliance requirements
Ability to review engineering records, maintenance records, calibration documentation, and related technical documents
Strong attention to detail, structured working approach, and ability to coordinate effectively with cross-functional stakeholders
Experience in pharmaceutical manufacturing, biologics, sterile manufacturing, or API production is an advantage
Exposure to validation, qualification, CQV, or GMP project support activities is preferred
Familiarity with equipment lifecycle management, preventive maintenance, calibration programs, or asset management systems is an advantage
Experience supporting audit readiness or GMP documentation remediation activities is preferred

Job Responsibility

Support engineering system checks within a GMP manufacturing environment
Review asset records and equipment status to ensure proper documentation and compliance
Conduct or support maintenance risk assessments for manufacturing and engineering systems
Review calibration status, calibration records, and related documentation
Assess whether engineering activities may impact GMP compliance, product quality, or equipment readiness
Collaborate closely with Engineering, Quality, Maintenance, Validation, and Manufacturing teams
Review and support preparation of GMP documentation, reports, checklists, and compliance records
Identify documentation gaps and support follow-up actions or remediation activities
Ensure all work is performed in line with GMP, GDP, and site quality requirements

What we offer

An international community, bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact
Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support

Fulltime

Product Specialist

Product Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline, preferably Biomedical Engineering, Life Sciences, or a related field
At least 3 years of experience as a Product Specialist or similar role in the medical device industry
Strong knowledge of the medical device sector, including regulatory requirements and compliance standards
Excellent communication and presentation skills, with the ability to convey technical knowledge to non-technical audiences
Analytical skills to assess market data and develop effective sales strategies
Willingness to travel frequently to meet clients and attend industry events
Fluency in English, both written and spoken

Job Responsibility

Build and maintain strong relationships with existing customers by planning and organizing regular visits to ensure continuous support and identify new sales opportunities
Develop new business opportunities and convert them into long-term partnerships, contributing to sales success
Provide technical support and clinical training to customers on the effective use of medical devices, ensuring a high level of customer satisfaction
Coordinate and organize hands-on demonstrations, presentations, and educational programs for healthcare professionals, representing the company at congresses and symposiums
Actively collaborate with internal departments, including R&D, marketing, and quality assurance, to ensure effective product strategy alignment

Quality and Compliance Manager

The Quality and Compliance Manager (EMEA Sub-Regional lead) provides quality sup...

Location

Belgium , Antwerp

Salary:

Not provided

JLL

Expiration Date

Until further notice

Requirements

BSc degree in life science, engineering or equivalent
Minimum of five (5) years of experience in quality and/or compliance in engineering, facilities management, production, operations, lab operations or equivalent
Prior experience working in a GMP environment preferably in pharmaceutical and/or biotechnology
Experience leading investigations, change control, root cause analysis (RCAs) and CAPAs in a regulated environment
Experience in supplier management in GxP environment
Strong leadership experience and experience interacting at all levels
Strong knowledge and understanding of Quality Management Systems (ISO 9001, ISO 13485 and/or GMP) and EMEA cGxP standards and regulations in Pharmaceuticals and/or MedTech
Ability to communicate effectively in oral and written reports
Good customer service skills and relationship building skills
Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision

Job Responsibility

Support the implementation and maintenance of the JLL ISO 9001 QMS and cGxP requirements on the account
Support the implementation and maintenance of the account Quality Management Plan (QMP)
Serve as the account quality contact and subject matter expert (SME) in the sub-region
Support the implementation and maintenance of the Quality Agreement between JLL and the client for sub-region and/or sites in their scope
Ensure training compliance in sub-region or sites in scope, through document reviews, self-assessments, audits, etc.
Support the implement Quality and Compliance programs on the account, to ensure sustainability of service quality
Prepare and manage quality documentation e.g. SOPs, change control documentation, quality agreements, training materials, investigations, CAPA, etc.
Lead and support JLL quality related complaints, change controls, deviations, investigations, root cause analysis (RCAs) and CAPAs in sub-region or sites in their scope
Perform qualification of cGxP impacting vendors, establish quality agreements, conduct vendor quality performance reviews and maintain the account approved supplier list (ASL)
Interface and represent JLL with the client FM teams and reporting of regional KPIs on a monthly basis

Fulltime

Senior Specialist, Quality Assurance

Serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Suppl...

Location

United States

Salary:

149651.00 - 168146.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of Quality Compliance experience
Master’s degree & 4 years of Quality Compliance experience
Bachelor’s degree & 6 years of Quality Compliance experience
Associate’s degree & 10 years of Quality Compliance experience
High school diploma / GED & 12 years of Quality Compliance experience
Bachelor’s degree in Life Sciences or Engineering
Experience leading or participating in key roles for Regulatory/Health Authority inspections
Experience auditing and defending processes/procedures during inspections
7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management

Job Responsibility

Own and lead the SQM/GSQ inspection readiness processes
Provide strategic and tactical leadership for inspection and audit preparation, execution, and response
Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites
Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates
Maintain and continuously improve inspection readiness processes
Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and internal audits
Drive proactive identification, communication, and resolution of site and cross-functional compliance risks
Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation
Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation

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
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Quality Assurance

Location

Ireland , Dublin

Salary:

Not provided

Executive Talent

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or Life Science related discipline
2+ years of Quality Assurance experience in a Life Sciences environment
Manage internal ISO quality process
Understanding of principles of Validation and New Product Introduction
Experience in change control, non-conformance, corrective and preventative actions, and validation practices
Proven experience participating in or leading audits and inspections

Job Responsibility

Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations
Quality review and approval of Validation documentation and SOPs to support site validation activities: Review of DS & QRAES documents
Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
Review of executed validation documents and reports
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records
ensuring scope of record is clear and implementation activities are robust and timely
Perform all activities in compliance with company safety standards and SOPs

Fulltime

Quality Director

As the Quality Director Duncan you will collaborate closely with cross-functiona...

Location

United States of America , Duncan

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

Hold a Bachelor’s degree, preferably in Science, Business, or Engineering
Have at least 7 years of experience in Quality Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA/EPA-regulated manufacturing environments
Possess 5+ years of leadership experience, with senior leadership roles in QA, Operations, or Quality Engineering preferred
Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR requirements, and quality management practices, including operational controls, CAPA, complaints, audits, and risk management
Proficiency in quality statistical methods, Lean Manufacturing principles, Six Sigma methodologies, and Root Cause Analysis tools to drive data-driven decisions and resource optimization
Proven ability to lead, coach, and mentor teams
manage performance
plan succession
and effectively communicate at all organizational levels, both written and verbal
Skilled in managing budgets, assessing opportunity costs, and fostering innovative problem-solving, while maintaining exceptional organizational and time management capabilities

Job Responsibility

Serve as the Duncan site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals
Implement, maintain, and optimize the Cytiva QMS, ensuring procedures, work instructions, and IT systems
Support site operations and customer expectations
Drive continuous improvement with DBS mindset and in line with the global standards and customer expectations
Collaborate with site and global leadership to advocate for site-specific needs, drive customer-centric solutions, support change management and change control initiatives
Build a high-performing quality department, fostering a safe, transparent and empowering environment that encourages skill development, psychological safety, and continuous improvement
Drive efficiency in site specific quality processes
Lead Quality Management Reviews for the site, define and monitor KPIs in line with the global guidelines, host audits, and represent the site in executive discussions and global best practice initiatives

What we offer

health care program
paid time off

Fulltime

Life sciences quality and compliance engineer

Sopra Steria

Location:
Belgium , Machelen

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 25, 2025

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