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
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.
Definition of functional, technical and quality requirements.
Realization of reviews of process studies, P&ID’s and layout.
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,…)
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 Anaïs Malikian, [email protected]
Be accountable for technical management including risk management, deviation ownership, change control authoring and coordinating, Product Technical Specification (PTS) and Method of Production (MOP) review and knowledge management. Participate to CC Implementation committee.
Review and approve demand versus supply, assess the capacity available, identify potential risks to service and identify requirements to capacity adjustments to meet future volume projections. Give, understand and master the inputs/outputs of SRM meeting.
Ensure visibility is given on demand and supply information across the supply chain to ensure pro-active management and avoid out of stocks, performance management through set-up, measurement, monitoring and reporting of KPI’s
Drive continuous improvement projects with his/her CMO and with internal and external stakeholders in order to strengthen the CMO operational activities. Support continuous improvement for complex/transversal projects.
Give support to the QA team to ensure compliance of the ES operations with cGMP and Authorities requirements.
Timely escalate issues to Manager if required by internal process
Be accountable for reporting (KPI, monthly)
Be the back up of the SRM (Supplier Relationship Manager
Who are you ?
Experience (preferable 1-3 years) in the following :
(Bio)pharma & cGMP
Quality
Project management
Bilingual French/English (oral & written)
Proactive with ability to identify and follow up on gaps in process
Ability to work under pressure due to the requested flexibility and reactivity of the activities
Be able to manage short term issues with long term activities in parallel.
Ability to work in project teams in a multidisciplinary environment and a matrixial organization
Be able to lead and manage cross-functional projects
Excellent communication and negotiation skillsOur 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.
Your responsibilities: Support the Quality SPOC for selected contractors / suppliers (in transfer or in commercial operations) for:
Ensuring that Quality systems are in place/in use, routinely monitored and assessed
Mastering quality agreement content
Releasing validation and/or commercial batches, including production and Quality control documentation, within the time frame defined by submission or Market needs and in compliance with regulatory files, good manufacturing practices and regulatory requirements, certify release process and evaluate regularly the certification status
Ensuring all quality activities linked to the contractor / supplier management (deviations, CAPA closure, change control, risks management, complaints, product quality review, …)
Ensuring and maintain good relationships with the contractor in order to guarantee win-win collaboration, through informal meetings and governance meetings.
Representing the QA External Manufacturing within various governance meetings and timely escalate issues to Manager if required by internal process
Identifying risks associated to the specific activities of the CMO
Driving continuous improvement projects with CMO and with internal and external stakeholders (Operations, Technical group, etc.) in order to strengthen the manufacturing activities
Your profile:
University Scientific background (Pharmacist, Phd in life sciences, Bio Engineer …).
Min. 5 years of experience in Pharmaceutical Industry associate with a GMP background
Experience as in QA or production department, with expertise on the field, in quality systems or release. SAP experience is mandatory (deviation, CC, CAPA, …).
Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
Fluent in English and French
Excellent communication (including presentation) and influencing skills.
Stakeholders’ management: ability to interact with internal & external stakeholders
Ability to travel to CMO (less than 1x/2month)
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 or send me your CV, [email protected]
En tant que Gatekeeper, vous assurez la qualité et la validité des demandes de travail, les planifiez ensuite en accord avec la production et les équipes de maintenance afin de réduire les temps d'arrêts planifiés et en augmentant l'efficacité de la main d'œuvre.
Vos responsabilités :
Vous collectez toutes les demandes de travail, et faites un suivi et un retour aux demandeurs ;
Vous évaluez la validité des demandes de travail, leur pertinence, et leur niveau de détail adapté ;
Vous êtes le garant du Backlog des avis, et de l’absence de doublons dans les systèmes ;
Vous préparez le planning court terme (1-4 semaines) avec une granularité à la pause / shift, pour tous les type d’activités ;
Vous animez la réunion de planification hebdomadaire avec la production ;
Vous planifiez les ordres de travail, y compris la préparation et le suivi de planification mensuelle et hebdomadaire ;
Vous conciliez le planning de maintenance avec le planning de production afin que les différentes activités soient totalement alignées.
Pourquoi vous ?
Qualifications requises :
Vous possédez un bachelier technique ou expérience équivalente ;
Vous possédez des connaissances des outils informatiques Excel, PowerPoint, Word, SAP ;
Vous possédez de minimum 5 ans d’expérience pertinente dans un environnement pharmaceutique.
Horaire de jour (flottant).
Qualifications souhaitées :
Vous êtes ouvert aux nouvelles idées, montrez un intérêt pour élargir vos connaissances, accompagnez le changement, proposez des améliorations en vue d’améliorer la performance ;
Vous vous organisez de façon autonome en fonction des priorités journalières, démontrez spontanément un souci d’ordre et de rigueur. Vous confirmez la planification des ordres de travail avec le client interne et la maintenance ;
Vous faites preuve d’esprit d’observation, vous signalez les anomalies, démontrez la compréhension du process en place.
Si vous avez besoin d’assistance ou d’aménagements particuliers, soit pour participer au processus de recrutement, soit pour vous permettre d’exercer votre travail, nous vous remercions de nous en informer de manière à ce que nous puissions prendre les mesures adéquates.
Notre Offre Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
