Life sciences quality and compliance engineer Jobs

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

New

Quality Assurance Engineer

Beacon Hill Life Sciences is looking for a Quality Assurance Engineer to conduct...

Location

United States , Noblesville

Salary:

35.00 - 37.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

Requirements

Bachelor of Science in Biology, Chemistry, or related field required
3 or more years of relevant experience required
Must be able to resolve problems, handle conflict, and make effective decisions under pressure
Ability to do simple to complex math calculations, input data into the computer, and analyze data as required
Must be proficient in the use of Microsoft Office suite products
Good computer skills, including utilizing personal computers and data entry programs
Good hands-on, analytical, problem-solving, and decision-making skills
Excellent writing and verbal communication skills
Ability to work independently and with others to accomplish goals and priorities
High energy level and regular, consistent attendance

Job Responsibility

Identify and implement Corrective Actions Investigate Exceptions (Deviations)
Generate or review Change Controls for Batch Records, Standard Operating Procedures, Standard Test Methods, Specifications, Data Sheets, etc.
Employ the use of quality tools (i.e., FMEA, Fishbone, 5 Whys, Risk Analysis, HFAT, etc.) in support investigations and special projects
Perform analysis of data in support of investigations, cost savings, and continuous improvement initiatives
Work with radioactive materials
Ensure a safe, high-quality working environment through training, awareness, and compliance with safety/Quality guidelines and SOPs
Maintain current knowledge of US and international quality regulations
Author or perform peer review of annual product quality reviews
Provide support for regulatory agency on-site audits (e.g., FDA, HC, TGA, EU, etc.), as required
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

Fulltime

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

Mechanical Engineer III

ATS Life Sciences Chicago, a leader in automation solutions for the life science...

Location

United States , Rolling Meadows

Salary:

90000.00 - 102000.00 USD / Year

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Mechanical Engineering, Engineering Technology, or related field
6+ years of experience in mechanical design for automation equipment
Advanced proficiency in 2D AutoCAD and 3D SolidWorks (or equivalent CAD platforms)
Skilled with Microsoft Office and general computer applications
Proficient with measuring tools such as calipers, micrometers, and other inspection equipment
Strong project management, organizational, and problem-solving skills
Ability to lift up to 50 lbs occasionally
up to 10 lbs frequently
May require standing, walking, bending, and reaching
Normal visual and auditory acuity required

Job Responsibility

Lead the design of cam, servo, and air-operated stations
modify and improve existing systems
Execute complex cam (drive) designs and ensure they meet performance, cost, and durability requirements
Research and specify appropriate materials, mechanical components, and vendors
Create and manage detail drawings, assembly drawings, BOMs, and release packages
Develop pneumatic and timing diagrams
select sensors and other components
Act as the Mechanical Engineering Lead on all project sizes, including multi-module, large-scale systems
Work closely with cross-functional teams and customers during all phases of design reviews
Ensure all designs comply with ATS Life Sciences Chicago standards, ISO 9001/13485, and applicable regulatory requirements

What we offer

Compensation for hours worked over 45
paid time off (PTO)
employee incentive bonus program
comprehensive benefits (including health, dental vision and employee assistance program)
a wellness reimbursement
tuition reimbursement
annual paid volunteer day off
401K with employer match
optional employee share purchase program

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

Vice President of Quality

The Vice President of Quality is a strategic and operational executive responsib...

Location

United States

Salary:

180000.00 - 200000.00 USD / Year

Strive Compounding Pharmacy

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, Biology, or related field
15+ years of progressively responsible Quality leadership experience
Demonstrated success scaling Quality systems in a highly regulated environment
Deep expertise in cGMP, FDA regulations, ISO or equivalent industry standards
Proven track record leading audit readiness, compliance, and continuous improvement programs
Executive presence with strong communication, influence, and stakeholder alignment capability

Job Responsibility

Develop and lead a comprehensive Quality strategy aligned with organizational priorities and growth objectives
Build and scale world-class Quality Management Systems (QMS) that support operational reliability, regulatory excellence, and continuous improvement
Act as a key advisor to the Executive team on quality related risk, compliance health, and improvement opportunities
Champion a culture of quality, accountability, and proactive problem-solving across all levels of the organization
Ensure full compliance with applicable regulations such as FDA, cGMP, 21 CFR, USP, ISO standards, state board regulations, and other governing bodies relevant to the business
Lead preparation for and responses to regulatory inspections, customer audits, and certification activities
Oversee internal audit programs, CAPA management, risk assessments, product release processes, and validation activities
Lead Quality Assurance, Quality Control, training, and documentation teams to achieve performance, throughput, and reliability expectations
Establish and track Quality KPIs and dashboards (such as, complaint trends, deviation rates, batch failure rates, inspection outcomes)
Collaborate with Operations and Supply Chain to drive defect reduction, process optimization, and preventive quality initiatives

What we offer

employer paid healthcare coverage available after 30 days of employment
choice of an FSA/HSA
voucher for new hire scrubs (if applicable)
parental leave
401(k) plan with matching contributions
weekends and holidays off
FREE COMPOUNDED MEDS to employees and immediate family members

Fulltime

Group Leader, Formulation Development & Manufacturing

This role is pivotal for delivering high-quality formulation and manufacturing s...

Location

Belgium

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

MSc or PhD in Pharmaceutical Sciences, Chemical Engineering, or a related discipline
significant hands-on experience in formulation development and GMP manufacturing
At least 8-10 years in the pharmaceutical industry, including experience working with oral and/or injectable dosage forms in GMP production settings
Proven leadership experience managing and mentoring scientific teams in both R&D and GMP production environments
In-depth knowledge of GMP regulations, drug product formulation, process optimization, tech transfer and regulatory documentation practices
Strong organizational, communication, and scientific reporting skills
capable of driving technical excellence in a growing team
Fluent in English

Job Responsibility

Lead, plan and oversee GMP production projects from formulation development through clinical batch manufacturing – ensuring deliverables are on time, within budget, and compliant with GMP standards
Translate project specs from Project Managers into actionable tasks for Development & GMP teams
supervise Associate Scientists in formulating and manufacturing oral and injectable dosage forms
Develop and refine formulation strategies, select excipients and delivery formats, and guide tech transfers from R&D to GMP production
Ensure documentation quality: master batch records, batch records, technical reports, GMP manufacturing reports
coach the team to maintain standards in non-conformance management and quality assurance alignment
Coordinate with QA / QP and supply chain to ensure availability of starting materials, manage deviations, and resolve GMP / compliance issues swiftly and effectively
Act as scientific & technical problem-solver: troubleshoot formulation, process, equipment, and compliance challenges when they arise
Represent the Formulation & GMP Manufacturing team in project core meetings
provide scientific input to clients and internal cross-functional teams

Fulltime

Director, Cold Chain Management & GDP Compliance

The Director, Cold Chain Management & Supply Chain GDP is a key role as part of ...

Location

United States

Salary:

169300.00 - 253900.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Engineering, Supply Chain, Life Sciences, or related field
10+ years of experience in pharmaceutical supply chain, with significant expertise in cold chain and GDP compliance
Proven leadership experience in a global, matrixed organization
Strong knowledge of regulatory requirements (EU GDP, FDA, WHO, etc.)
Excellent communication, stakeholder management, and problem-solving skills
Bachelor’s degree in related curriculum with a minimum of 10-12 years of experience in global trade compliance
Previous experience leading a global team
Thorough understanding of technology tools, cold chain related systems and ERP systems, with a proven record of implementing scalable compliance solutions (systems, procedures, and processes)
Strong analytical and organizational skills with the ability to anticipate problems and take proactive actions
Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk

Job Responsibility

Lead the design, qualification, and continuous improvement of cold chain systems and packaging solutions for temperature-sensitive products
Oversee monitoring of temperature-controlled logistics, including refrigerated transport, passive packaging, and storage facilities
Collaborate with internal and external stakeholders to ensure robust cold chain solutions across global markets
Drive innovation in cold chain technologies and the streamlined management and quality of associated data
Ensure global compliance with GDP regulations and internal quality standards across all distribution channels
Develop and maintain policies, procedures, and training programs related to GDP and supply chain integrity
Primary point of contact in Supply Chain for audits and inspections related to distribution and cold chain operations
Partner with Quality, Regulatory, and Logistics teams to proactively identify and mitigate compliance risks and bridge operational gaps
Direct management of a team of individual contributors across global regions
Provide strategic direction and leadership to cross-functional teams involved in cold chain and compliance activities

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

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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