- Have a knowledge of current Industry standards, regulatory requirements and Authority expectations regarding CSV
- Develop project specific CSV approach and methodology
- Prepare project CSV deliverables:
- User Requirement Specifications
- Risk and Impact Analysis/Assessment (Process, Business, EHS, Regulatory)
- Validation Master Plan (VMP)
- Design Review/Qualification
- Test Matrices
- FAT, SAT, Commissioning, IQ, OQ, PQ protocols and reports
- Support in project schedule for CSV activities
- Organise, execute and document CSV testing
- Support during system/installation start-up in function of CSV test activities
- Set up and follow up of Project documentation System and Management
- Work in close collaboration with Project, Engineering and CQV Management
- You hold a (Professional) Bachelor or a Master's degree (or equivalent by experience), ideally in automation-regulation, Robotics, IT or relevant other expertise
- You have a significant (or a first) experience in Life Sciences industries and industrial automation processes, ideally min. 3 years in CSV
- You have excellent communication skills in English and French OR in English and Dutch (written and spoken)
- You have an enhanced knowledge of current Industry Standards, Regulatory requirements and Authority expectations (Eudralex, FDA, PICS, ICH, ISO, ASTME
- You have a good Comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry
- You know the latest developments in the C&Q field and relevant legislation and industry standards (cGMP).
- Technical expertise in engineering, electricity or automation
- You have a field experience with:
- Scada, supervision and computerized system
- Experience in IT regulation
- Experience in Computerised System Validation
- Familiar with IT/IS systems
- You are structured, conscientious and a precise fast-learner
- You are a real team player who can also work independently
- You are ready to travel and you are flexible on schedules and duties
- You are resourceful with a CAN DO mentality who can think proactively
- A challenging position: Freelance or Employee
- A full time contract 40hr/week
- Location: Flexible depending to clients' locations
- A challenging job in a dynamic and knowledge-sharing network company
- The freedom to develop yourself in line with your ambition
- A great autonomy in your role, an excellent working atmosphere within a great team of Experts in their domain
- For employees: a competitive salary, 32 annual days off and other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription
-
Pharmaceutical Project Manager F/m/x
1 week geleden
Amaris Consulting Brussels, België**Who are we?**: · **Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an ...
-
Pharmaceutical Project Manager F/m/x
6 uur geleden
Amaris Consulting Brussels, België**Who are we?**: · **Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by a ...
-
CQV Engineer for pharmaceutical projects
6 dagen geleden
3HR Wallonia, België CDIThe Scope · Our client is a new Engineering office active in various Life Science Industries like Pharmaceutical, Biotechnology, Medical Devices, with expertise in Qualification & Validation, Quality Assurance, Consulting, Engineering and Construction Management. · With a consta ...
-
Network Capacity Planning
6 dagen geleden
Keyrus Life Science Belgium Waterloo, België**Job Purpose** · The PLDC NCP Lead will ensure that PLDC's manufacturing capabilities are aligned with its business requirements and strategic objectives. This will be done by analysis of the current capacity, forecasting future capacity requirements, identifying potential const ...
-
Clinical Project Expert
1 week geleden
Keyrus Life Science Belgium Waterloo, BelgiëKeyrus Life Science is looking for a Clinical Process Expert to **join our team based in Waterloo, Belgium** · The **Clinical Project Expert **is accountable for the design and implementation of systems and processes within the **R&D manufacturing and Clinical Supply activities** ...
-
Senior Medical Writer
1 week geleden
Keyrus Life Science Belgium Waterloo, BelgiëKeyrus Life Science is looking for a Senior Medical Writer to join their team based in Waterloo. · Your challenges will be: · - Synthesize literature review findings into reports in various therapeutic area; · - Write, edit and update clinical development related documents with t ...
-
Project Manager/scientist in Organic Chemistry
2 dagen geleden
NovAliX Braine-l'Alleud, BelgiëWithin a NovAliX insourcing team based in a pharmaceutical company, under the responsibility of a team leader or a senior project manager, your mission will mainly consist in: · - Elaborating and conducting syntheses to deliver new chemical entities for pharmaceutical research pr ...
-
Project Manager/scientist
2 dagen geleden
NovAliX Braine-l'Alleud, BelgiëWithin a NovAliX insourcing team based in a pharmaceutical company, your mission will mainly consist in: · - Conducting large scale syntheses (up to several hundred grams) to deliver new chemical entities and key building blocks for pharmaceutical research programs. · - Ensuring ...
-
Project Manager/scientist in Organic Chemistry
1 week geleden
NovAliX Braine-l'Alleud, BelgiëStarting date: ASAP · Type of contract: Permanent · Location: Braine l'Alleud, BELGIUM · Job offer: Project Manager/Scientist in Organic chemistry (M/F) · Job description · Within a NovAliX insourcing team based in a pharmaceutical company, under the responsibility of a team lead ...
-
Project Manager/scientist
1 week geleden
NovAliX Braine-l'Alleud, BelgiëStarting date: ASAP · Type of contract: Permanent · Location: Braine l'Alleud, BELGIUM · Job offer: Project Manager/Scientist - Scale-up chemist (M/F) · Job description · Within a NovAliX insourcing team based in a pharmaceutical company, your mission will mainly consist in: · - ...
-
Software Development Intern
2 dagen geleden
BAXTER Braine-l'Alleud, België**This is where you save and sustain lives** · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves ...
-
Engineering Specialist
2 dagen geleden
Jefferson Wells Braine-l'Alleud, BelgiëLocation: · **Braine L'Alleud** · - Type: · **Contracting** · **#20719** · **Project Engineering Leader** · Brabant Wallon - contracting · Our partner is looking for a **Project Engineering Leader and a Construction Manager** to join its team. This international company is well-k ...
-
Global Infrastructure and Facility Expert
4 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · To strengthen our Asset Management Department, we are looking for a talented individual and self-motivated to fill the position of Global Infrastructure and Facility Expert based in Braine l'Alleud (Belgium) or Bulle (Switzerland). · In this posi ...
-
Quality Partner Biotech Sciences Ops&qp
4 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · To strengthen our **Quality Assurance team, **we are looking for a high caliber, self-motivated**, **Quality Partner Biotech Science Ops & QP** based in **Braine l'Alleud, Belgium**. · **At UCB everything we do starts with a simple question: "How ...
-
Sme E&i
4 dagen geleden
Jefferson Wells Braine-l'Alleud, BelgiëLocation: · **Braine-l'Alleud** · **#24210** · **SME E&I**: · Brabant Wallon - contracting · Our partner is looking for a **SME E&I** to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. · ** ...
-
Quality Partner Biotech Sciences Ops&qp
3 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · To strengthen our **Quality Assurance team, **we are looking for a high caliber, self-motivated**, **Quality Partner Biotech Science Ops & QP** based in **Braine l'Alleud, Belgium**. · **At UCB everything we do starts with a simple question: "How ...
-
Industrial Lead Analytical Associate
2 dagen geleden
UCB Braine-l'Alleud, België**Make your mark for patients** · To strengthen our **Product Strategy and Industrial Impl. team, **we are looking for a high caliber, self-motivated**, Analytical Project Lead **based in **Braine l'Alleud, Belgium.** · **At UCB everything we do starts with a simple question: "Ho ...
-
QA Officer
1 week geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · We are looking for a self-motivated **QA Officer - Analytical Services / Quality Control **who is enthusiastic to join us in our **Quality Assurance, Braine Technical Ops** team, based in our UCB Campus located in **Braine-l'Alleud** in **Walloon ...
-
Head of Analytical Sciences Portfolio
1 week geleden
UCB Braine-l'Alleud, België**Make your mark for patients** · We are looking for a **Head of Analytical Sciences Portfolio** with good ability to collaborate and influence in a multidisciplinary team to join us in our Development Science organization based in Braine-l'Alleud, Belgium. · **About the role**: ...
-
Cmc Product Portfolio Manager
2 dagen geleden
UCB S.A. Braine-l'Alleud, België**Make your mark for patients** · To strengthen our Product Strategy & Industrial Implementation department, based in our hub in Braine-l'Alleud, Belgium, we are looking to fill the position of**:CMC Product** **Portfolio Manager** · **As a UCB CMC Product Portfolio Manager, you ...
CSV Engineer for pharmaceutical projects - Walloon Brabant, België - 3HR
4 dagen geleden
Beschrijving
Our client is a fast growing company active in various Life Science Industries like Pharmaceutical, Biotechnology, Medical Devices, with expertise in Qualification & Validation, Quality Assurance, Consulting, Design Engineering and Construction Management.
With 20 employees/freelances and many clients in Belgium, the company is now looking for an experienced Computerised System Validation Engineer (Freelance or Employee) for pharmaceutical projects in Belgium with very occasional travels abroad (mainly in BeNeLux and France, Germany and Switzerland). This position is also open to high potential graduated and Junior Engineers.
Do you like working in a small business with a family ambiance?
Are you ready to contribute to their continued growth?
Do you have an entrepreneurial mindset and are you passionate about working in Life Science industries?
We love meeting smart and forward-thinking talents, so don't hold back
Your next challenge and responsibilities
As one of our CSV Engineers, you will
You could be our ideal colleague if
REM: Only short-listed and Europe-based candidates will be invited for an interview, thanks for your understanding.
We offer you
Besides an exciting flexible environment, a unique chance to participate in challenging and innovative projects and interaction with inspiring colleagues who have a professional attitude and attach considerable importance to teamwork; we stand for
Would you like to work for a small company with a top level service?
We are looking forward to meeting you soon.
Your application
We're looking for motivated and passionate individuals who love to build things and solve problems.
If this is you, please apply here or address your application, CV and a short motivation text, to us:
Mrs. Gwendoline de Robiano with Reference « Permanent/Freelance CSV Engineer »
REM: Only short-listed and Europe-based candidates will be invited for an interview, thanks for your understanding.
