Analytical Methods Validation Bio

  • Location: Wavre
  • Type: Contracting
  • Job #7583

Analytical Methods Validation Bio

Brabant Wallon – contracting 

#Pharma #QC

Our partner is looking for an Analytical Methods Validation Bio to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

Within the Global Quality Control New Analytical Technology and Strategy department in close collaboration with local Quality Control sites around the world, you will participate to the identification, evaluation, and implementation of new or alternative analytical technologies to optimize Commercial Quality Control testing efficiency. Here are your mains tasks:

  • Organize benchmarking and technological watch to identify suitable analytical technologies focused on Automation.
  • Define plans for the evaluation of these new technologies and will lead the evaluation process by:

-Designing and organizing feasibility studies with the aim to confirm experimentally the expected theoretical benefit of the selected technology

-Designing and organizing proof of concept studies to confirm experimentally the suitability of the analytical method developed with the selected technology

  • Elaborate business case to demonstrate the economic benefits of investing and deploying this new analytical technology in the QC network.
  • Conduct experiments to support feasibility and proof of concepts studies to integrate new technologies on different QC sites
  • Closely interact with local QC sites across the network, quality, legal/IP and procurement partners

Who are you?

  • You hold a master’s degree in Biology/Biochemistry
  • You have a first experience in automation within the pharmaceutical industry
  • You have good knowledge in analytical techniques
  • You have good communication skills and are flexible
  • You are fluent (both written and spoken) in French and English

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Sophie Rolis: [email protected] or +32497/51.50.92

Laborant

  • Location: Dendermonde
  • Type: Temp
  • Job #13094

Laborant

Vast Contract – Regio Dendermonde
#chemie #qc #R&D

Beschik je minstens over een wetenschappelijke bachelor? Heb je werkervaring met analytische testen in de chemische sector? Heb je een oog voor detail en werk je resultaatsgericht? Lees dan jouw toekomstige jobomschrijving.

Onze partner is op zoek naar een Laborant om hun laboteam te versterken. Dit sterk groeiend productiebedrijf gelegen in de regio Dendermonde is internationaal actief binnen de chemische sector.

Jouw verantwoordelijkheden?

Als Laborant kom je terecht in een dynamische omgeving en krijg je de verantwoordelijkheid over het aanmaken en het uitvoerig testen van chemische verbindingen. Met behulp van een divers takenpakket, word je hierin bijgestaan:

  • Formules bijwerken en uittesten
  • Aanmaken van compounds en het uitvoeren van kwaliteitscontroles
  • Toepassen van de verbindingen op stoffen
  • Testen van nieuwe grondstoffen
  • Documentatie opstellen van uitgevoerde experimenten
  • Resultaten direct rapporteren aan de labo coördinator

Wie ben je?

Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Laborant over een wetenschappelijke bachelor aangevuld met een eerste relevante werkervaring. Ervaring binnen een chemisch labo is een pluspunt. Je bent communicatief vaardig in het Nederlands en Engels. Daarnaast heb je een ordelijke ingesteldheid en sta je organisatorisch sterk. Tot slot ben je ook een flexibel persoon die zowel zelfstandig als in teamverband logisch redeneert.

Wat kan je verwachten?

Als Laborant kom je terecht in een actieve en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen.

Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Matthias Kegels op het nummer +32 (0)4 76 35 74 35 of via matthias.kegels(@)jeffersonwells.be

Process Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #16621

Process Engineer

Brabant Walloon – contracting

Our partner is looking for a Process Engineer to join its team. This international company is well-known for its pharmaceuticals.

Your responsibilities?

In coordination with Engineering Office and Project Management, you will provide expertise in the implementation of good engineering & design practices and solutions to support design, execution and commissioning / qualification phases of CapEx Projects.

You will ensure correct design, construction, commissioning, and qualification in full compliance with internal requirements and authorities' requirement of Secondary equipment’s and Aseptic technologies package.

Related to these packages, it includes:

  • Being the internal representative for all Secondary equipment’s and Aseptic technologies-related activities and installations
  • Supporting the E.O in management of activities related to this package
  • Ensure regular technical contact with MPU representative (User, QA, Validation, Maintenance,…)
  • Ensuring alignment between E.O and the company Specification and Guidance
  • Reviewing design and technical documentation
  • Following-up construction & all testing activities falling under the package’ scope
  • Ensure systems start-up and punch list solving
  • Writing and executing commissioning and qualification protocols/reports
  • Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
  • Facilitating handover process towards the end user

Your profile?

  • Engineering degree with 7 years’ experience as Process Engineer in Secondary Equipment’s and Aseptic Technologies domains.
  • Strong Experience in the Pharmaceutical industry and cGMP environment.
  • BA4 BT electrical certification.  
  • Definition of functional, technical and quality requirements.
  • Realization of reviews of process studies, P&ID’s and layouts
  • Oversight contractor's performance.
  • Integration of operability and EHS requirements at all design steps.
  • Preparation of the project testing, commissioning and inspection requirements
  • Organize legal conformity visits
  • On-site verification of execution according to good practices
  • Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…),..
  • Team working & Communication, Autonomy, Contractors' management.
  • Good project integration experience: organization, schedule, qualification, validation, technologies.

Our offer?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact beatrice.stroobants@jeffersonwells.be 

QA Validation

  • Location: RIXENSART
  • Type: Contracting
  • Job #16671

QA Validation

Walloon Brabant – Contracting

#qa #validation #oversight #validationplan #changecontrol #pharma #gmp

You have experience in quality assurance? You are quality oriented? Keep reading your future job description. 

Our partner is looking for a QA Validation to join its team. This international company is well-known for its pharmaceuticals and vaccines.

What are your responsibilities?

As a QA Validation, you will ensure the QA oversight of the continuous validation activities for one or several production units. To be successful in your role, here are your tasks:

  • Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the standards and procedures.
  • Write some validation (VP, PQ, PV, VSR, PVR) documentation according to the standards and procedures.
  • Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA).
  • Maintain a capacity management of the resources needed to implement the quality commitment within the CVP and manages the potential lack or tradeoff with the support of its management.
  • Support from a compliance point of view the MPU Product&Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders.
  • Support the validation approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product&Process, Production and QA Operations.

Who are you?

You have a degree in a scientific domain. You have experience in quality assurance and/or validation. You speak fluently French and you have an intermediate level in English.

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Béatrice Stroobants: [email protected]

Analytical Methods Validation

  • Location: RIXENSART
  • Type: Contracting
  • Job #16670

Analytical Methods Validation Specialist

Contracting – Walloon Brabant

#analyticalmethods #validation #immunoassays #qc #gmp #pharma

Our partner is looking for an Analytical Methods Validation Specialist to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?

As an Analytical Methods Validation Specialist, you will manage the feasibility & fit-for-purpose of new immunoassays. To be successful in your role, here are your tasks:

  • Feasibility, fit-for-purpose and method development design
  • Project management (stakeholder maping, planification)
  • Perform experimental plan, analyze the results, manage the troubleshooting
  • Manage lab work (training, stock management, data integrity)
  • Work in GMP lab environment
  • Protocol & report writing
  • Communication of the results

Who are you?

You hold a master’s degree or a phd in biochemistry or in immunology. You have a good knowledge of immunoassays development. You have experience in project management. You speak fluently French and English. You are autonomous and you have an analytical and synthetic mind.

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Béatrice Stroobants: [email protected]

Proces Manufacturing Engineer

  • Location: Bornem
  • Type: Contracting
  • Job #16770

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

We are looking for a Process Engineer Manufacturing to join our Engineering team. The Process Engineer supports site Operations, R&D and Quality to execute improvement plans utilizing Six Sigma, Lean and other approaches to improve the overall performance of the business.

 

Key responsibilities:

  • Adjust process parameters in consultation with production management (instructions, use of follow-up tools)
  • Organize the activities for production machine changes and special productions (size/bar changes, supros, special lengths)
  • Discuss shift report of production shift supervisor and start actions where appropriate. Conduct shift meeting together with production departments and M&E departments
  • Daily inspection and follow-up of the hard gelatine capsule machines for quality and quantity (scrap/losses). Accordingly, implement and delegate to day workers the actions to be taken (dimensional control, parameters humidity, weights, HCM set point changes, etc.)
  • Maintain close contacts with production operators, mechanics and QA engineers, explain procedures and motivate production personnel
  • Supervise the cleanliness and hygiene status (GMP) of the production room and correct where necessary
  • Guard process capabilities and take appropriate actions where needed (standardization of process)
  • Train new operators and colleagues in capsule production and in procedures, as well as in capsule quantity importance
  • Propose and implement process changes and programs also according quality plan, capital plan, Hfc program, HCM speed program and other programs
  • Participate in quality teams and RFT projects
  • Perform other duties as assigned.

 

Key requirements:

  • Master degree in Engineering in Elektromechanica, Chemistry, Bio-engineering or equivalent
  • Experienced in working in a manufacturing environment
  • Strong project development, implementation, and communication skills
  • Ability to work independently, with guidance in only complex situations
  • Knowledge of continuous improvement (greenbelt is a plus)
  • Highly organized and detail oriented
  • Fluent in English and Dutch

 

Every day, Our products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come  for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Are you interested? Apply now with your cv!

Project Lead – clinical study

  • Location: charleroi
  • Type: Perm
  • Job #16045

Project Lead – clinical study

Hainaut – CDI

#project #clinicalstudy #GLP #method #validation #assay #training

Are you interested in the biotechnology and putting your knowledge of clinical study to good use?

Our client is actively looking for a Project Leader to strengthen its activities. Our partner is active in the pharmaceutical sector.

What are your responsibilities?

As Project Leader – clinical study, you are in charge to

  • Management of method validation, assay transfer and sample analysis studies;
  • Prepares and/or reviews worksheets related to studies;
  • Ensures personnel are trained and training appropriately documented;
  • Ensures high level documents are signed and acknowledged by personnel involved in the study;
  • Ensures study binders are up to date;
  • Follows up on assigned study inventory and sample manifest;
  • Follows up on deviations ;
  • Follows up on QC review and ensures it is performed in a timely fashion;
  • Prepares and/or reviews of data tabulation and study related documents;
  • Works in collaboration with the Principal Scientists, the Research Assistants and the Research Associates; coordinates with the relevant transversal units (e.g. Data Analysis, QC, Sample Management, QA) to deliver quality data on time;
  • Submits studies to QA and answers to QA reports;
  • Schedules experiments based on the timelines, priorities and requirements;
  • Writes and reviews method SOP/CSP;
  • Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures;
  • Performs other duties as assigned;
  • Responsible for coaching, mentoring, training and day to day interaction with the Research Assistants and the Research Associates for assigned studies.

Who are you?

You are graduated as a Master degree in Life Sciences, preferably in Immunology. You have a minimum of 2 years of experience in similar position, in biotechnology. You have a good knowledge of clinical study conduct, a good knowledge and understanding of bioanalytical method validation guidelines and requirements. Also, you have knowledge and understanding of GLP, GCLP regulations to carry out GLP studies. You demonstrate knowledge of procedures and protocols for containment of biohazardous material, safety procedures and guidelines. You fluently speak English. Your soft skills are Strong quality mindset, strong cross-functional communication skills, capable of producing document of high quality, rigorous and autonomous in the conduct of their work, effective organizational skills and flexibility and ability to lead a study.

Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;

Employee is personally responsible for following Health and Safety guidelines/instructions. This position can involve evening and/or week-end work.

What can you expect?

A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.

You’re interested in this job? We kindly invite you to apply directly on our website experis.be. Do you have questions? You can contact Dimitri Soupart : [email protected]

Project Lead – clinical study

  • Location: charleroi
  • Type: Perm
  • Job #14687

Project Lead – clinical study

Hainaut – CDI

#project #clinicalstudy #GLP #method #validation #assay #training

Are you interested in the biotechnology and putting your knowledge of clinical study to good use?

Our client is actively looking for a Project Leader to strengthen its activities. Our partner is active in the pharmaceutical sector.

What are your responsibilities?

As Project Leader – clinical study, you are in charge to

  • Management of method validation, assay transfer and sample analysis studies;
  • Prepares and/or reviews worksheets related to studies;
  • Ensures personnel are trained and training appropriately documented;
  • Ensures high level documents are signed and acknowledged by personnel involved in the study;
  • Ensures study binders are up to date;
  • Follows up on assigned study inventory and sample manifest;
  • Follows up on deviations ;
  • Follows up on QC review and ensures it is performed in a timely fashion;
  • Prepares and/or reviews of data tabulation and study related documents;
  • Works in collaboration with the Principal Scientists, the Research Assistants and the Research Associates; coordinates with the relevant transversal units (e.g. Data Analysis, QC, Sample Management, QA) to deliver quality data on time;
  • Submits studies to QA and answers to QA reports;
  • Schedules experiments based on the timelines, priorities and requirements;
  • Writes and reviews method SOP/CSP;
  • Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures;
  • Performs other duties as assigned;
  • Responsible for coaching, mentoring, training and day to day interaction with the Research Assistants and the Research Associates for assigned studies.

Who are you?

You are graduated as a Master degree in Life Sciences, preferably in Immunology. You have a minimum of 2 years of experience in similar position, in biotechnology. You have a good knowledge of clinical study conduct, a good knowledge and understanding of bioanalytical method validation guidelines and requirements. Also, you have knowledge and understanding of GLP, GCLP regulations to carry out GLP studies. You demonstrate knowledge of procedures and protocols for containment of biohazardous material, safety procedures and guidelines. You fluently speak English. Your soft skills are Strong quality mindset, strong cross-functional communication skills, capable of producing document of high quality, rigorous and autonomous in the conduct of their work, effective organizational skills and flexibility and ability to lead a study.

Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;

Employee is personally responsible for following Health and Safety guidelines/instructions. This position can involve evening and/or week-end work.

What can you expect?

A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open.

You’re interested in this job? We kindly invite you to apply directly on our website experis.be. Do you have questions? You can contact Hanna MIMOUNI [email protected] or 0497059881.

Validation engineer

  • Location: Verviers
  • Type: Temp
  • Job #14681

Validation engineer

Verviers – CDI

#validation #engineer #protocols #reports #R&D #ISO #FDA #quality

You have a first experience in industry? You are an efficient person? You can handle different projects simultaneously owing to your organizational skills? Keep reading your future job description.

Our partner is looking for a Validation Engineer to join its R&D team. This international company is well-known in the sector of sterilization solutions.

What are your responsibilities?

As Validation Engineer, you work in close cooperation with the Validation Coordinator and you ensure that validation activities are carried out according to the agreed time-schedule. To be successful in your role, here are your tasks:

  • You write validation work instructions for production staff and the lab, and you make sure it complies with protocol requirements. (This includes but is not limited to: creation of validation items, creation of CSA, programming cycles in Antares and Scada, lab work request).
  • You are responsible for annual equipment re-commissioning (sterilization and laboratory).
  • You collect and prepare data to prepare validation reports.
  • You execute validation protocols and technically driven customer projects (which include but are not limited to the following:
  • Planning validation activities, project runs, ancillary resources, lab testing and sample handling, in order to minimize the risk of errors in the execution;
  • Cycle programming and preparation of necessary process documents and safety assessments;
  • Microbiological samples;
  • Data collection and analysis;
  • Prepare lab work request with all relevant information required to perform laboratory analysis.)
  • You update validation status in the relevant places.
  • You maintain the quality and integrity of information required for validation records. You report any deviation to the Validation Coordinator.
  • You provide support to Maintenance or Engineering in the performance of IQ/OQ/PQ activities of new or existing facility equipment.
  • You organize work of validation operators for load preparation.
  • You maintain the validation work area (you keep it clean and well organized).

Who are you?

You are graduated as an Industrial Engineer (or equivalent). You have a good knowledge of Modern Quality Systems and standards (ISO & FDA). Ideally, you have a first experience in the industry and in project management. You speak fluently French and English. You have excellent organizational abilities. You are efficient and accurate.

What can you expect?

Our partner offers you a key function under a temporary contract (6 months) and after that a permanent contract.

You’re interested in this job? We kindly invite you to apply directly on our website. Do you have questions? You can contact Hanna MIMOUNI, [email protected]

Mechanical Design Engineer

  • Location: Brugge
  • Type: Perm
  • Job #4259

Jefferson Wells is een gespecialiseerde selectiedivisie binnen de ManpowerGroup, die zich focust op ingenieursprofielen op zoek naar een nieuwe job.

Wij zijn op zoek naar een mechanical design engineer om de activiteiten van onze klant in regio Brugge te versterken. Het bedrijf heeft een klein, hecht team in de grote omgeving van Brugge en dat team ontwikkelt machines bestemd voor klanten wereldwijd. Het bedrijf heeft zelf ook meerdere vestigingen in het buitenland om zo een divers en volledig aanbod te kunnen bieden aan de klanten.

Deze functie is een primeur in de vestiging te Brugge, aangezien de mechanische opdrachten uitgevoerd worden door een andere entiteit binnen België, maar dankzij de groei van de laatste jaren wordt er geïnvesteerd in het mechanische gedeelte van de activiteiten. Je zult op maat van de klant, aan de hand van hun specs het mechanische ontwerp van de machines zelfstandig op jou nemen. Je houdt hier rekening met budgetten, coördineert je vooruitgang met het werk van de elektronica-groep, test prototypes uit en ziet toe op de productfiches. Hierbij zul je ook onderzoek doen naar nieuwe technologieën en materialen. Je rapporteert aan de Business Unit Manager, maar werkt ook nauw samen met de collega's van de andere vestiging in België.

Voor deze nieuwe rol zijn we op zoek naar een Industrieel Ingenieur met grote affiniteit voor mechanica en ontwerp of gelijkwaardig door ervaring (Elektromechanica, Productontwikkeling, etc.). Naast je aanleg voor mechanical design, is een goede basis elektronica een plus. Zowel ervaren kandidaten als schoolverlaters komen in aanmerking. Qua skills ben ik op zoek naar iemand die pragmatisch ingesteld is, analytisch en probleemoplossend te werk kan gaan en zeker ook creatief is. Belangrijkste qua talenkennis zijn Nederlands en Engels. Flexibiliteit en leergierigheid om een opleiding te volgen in de andere Belgische vestiging is ook noodzakelijk.

Onze klant biedt een interessante omgeving aan waarin je kunt groeien en enorm breed kunt gaan gezien de beperkte grootte van het team. Je zult fungeren als expert van het kantoor en de rol zelf verder vorm geven. Initiatief wordt gestimuleerd en gewaardeerd. Als deze vacature perfect jouw profiel omschrijft, aarzel dan zeker niet om mij te contacteren. Ik ben Kris Meert en vlot bereikbaar op het nummer 0477636242. Stuur zeker ook je cv op naar kris.meert(at)jeffersonwells.be!

Veel succes en tot gauw!