Secondary Packaging Industrialization Expert Contracting – Brabant Wallon Your Responsibilities
Lead packaging projects from initial design through to industrialization and lifecycle management of secondary and tertiary packaging solutions.
Provide technical expertise to internal sites, affiliates, and CMOs to ensure process efficiency, quality, cost optimization, and alignment with environmental objectives.
Manage projects, including change control processes, team communication, stakeholder engagement, and reporting to management.
Ensure compliance with international standards, regulations, and internal guidelines related to secondary and tertiary packaging.
Act as a subject matter expert for troubleshooting and optimization of packaging components and processes.
Support cross-functional teams, including purchasing, marketing, and supply chain, on technical packaging matters.
Lead and coordinate tech transfers, validation, investigations, and business support for packaging-related activities at internal and external sites.
Supervise communication and collaboration with one or more packaging sites.
Contribute to team objectives, planning, documentation, and continuous process improvements.
Your Profile · Proven experience in secondary/tertiary packaging within a pharmaceutical GMP manufacturing environment. · Hands-on experience in pharmaceutical project management, including tech transfers, product launches, and adapting to new regulations. · Strong analytical and conceptual thinking skills with the ability to understand complex technical and business challenges. · Capable of managing multiple projects and priorities efficiently, from development through commercialization. · Autonomous and pragmatic, with a proactive, problem-solving mindset and the ability to drive initiatives forward independently. · Demonstrated ability to work effectively within cross-functional and multidisciplinary teams. · Fluent in English (written and spoken); French is a plus. · Excellent communication skills, both written and verbal. · Positive and collaborative attitude with a strong sense of ownership. · Experience with artwork management is an advantage.
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]
Biomanufacturing Support USP Contracting – Brabant Wallon Your Responsibilities · Perform routine documentation and development-related tasks, while also addressing urgent technical issues (e.g., equipment or process failures). · Conduct technical investigations and ensure proper documentation of findings and actions. · Actively contribute to both planned and emergency tasks, showing flexibility and responsiveness. · Work closely with system teams, labs, and external subject matter experts (SMEs) to ensure seamless service integration. · Play a central role in coordinating development efforts and cross-functional collaboration. · Support ongoing projects and be fully involved in daily operations, ensuring a strong understanding of field and lab processes. · Demonstrate a high level of on-site engagement, especially during the first weeks, to ensure full integration and commitment.
Your Profile · Proven ability to manage complex expectations and contribute to project success in dynamic environments. · Strong background as a development writer, ideally in geo-related or technical development projects. · Autonomous and adaptable, with the ability to work independently in fast-paced and high-compliance settings. · Experience with service integration and cross-team coordination is essential. · Solid understanding of pharmaceutical processes and standards is important. · Excellent interpersonal and communication skills, with a proactive, field-oriented mindset. · Must enjoy being hands-on and present on-site, engaging directly with operational teams. · Fluent in English (written and spoken)
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]
Be the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) to allow assessment.
Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, SpiderImpact) and track the vendor’s performance
Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging
Be the point of contact for post-release vendor issues (supply chain, distribution, etc.)
As required provide Operational QA support to other vendors
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Act as a coach for VQL’s with less experience.
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Act as Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process
Your profile:
Master’s degree in Sciences
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Must be able to work independently and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
Possess good auditing capabilities and skills.
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Must have the ability to manage projects / activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
Root cause and risk management/assessment skills
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]
Document and Records Management Expert Contracting – Brabant Wallon Your Responsibilities
Perform quality control on non-clinical documents (protocols, amendments, reports, etc.).
Ensure compliance and readiness of documents for regulatory submissions.
Upload, index, and track documents in the Veeva Vault EDMS.
Oversee the document lifecycle, ensuring adherence to quality standards and GLP requirements.
Liaise with stakeholders (authors, QA, RA, etc.) to follow up on corrections and approvals.
Provide training and guidance to internal users on good documentation practices.
Participate in process reviews and continuous improvement initiatives for documentation workflows.
Your Profile
Minimum 8 years of experience in the pharmaceutical industry.
Strong background in regulated documentation management (GLP, GCP, etc.).
Deep understanding of non-clinical documentation and its lifecycle.
Hands-on experience with Electronic Document Management Systems (EDMS), preferably Veeva Vault.
Familiarity with regulatory requirements for submission-ready documents.
High level of digital literacy.
Comfortable working in high-compliance, traceability-focused environments.
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]
Conduct audits of Study Reports, Study Phase Reports, Study Plans and Study Plan Amendments to assure the applicable OECD guidelines, SOPs and the Analytical Methods have been adhered to and that reported results accurately reflect the raw data according to SOPs and associated controlled documents
Archive audit documentation per SOPs; e.g., issued audit reports, supporting documentation, QAS, additional documents as expected according to SOPs and associated controlled documents
Follow up with CAPA owners to manage actions to an on-time completion according to SOPs and associated controlled documents Issue Management
Contribute to investigations of non-compliance to areas of research and development operations which are within the scope of the Good Laboratory Practice (GLP) Compliance Program, the Good Clinical Practice (Laboratory) Guidelines (GCP Lab), and relevant Human Tissue regulations according to Policies and Procedures
When requested, facilitate discussions with internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance to according to Policies and Procedures and OECD Principles. Inspection Readiness Support
Provide support during GLP/GCP inspections and investigations conducted by international and national authorities or business partners according to Policies and Procedures as requested Other Responsibilities
When requested, represent R&D and PV Quality at interdepartmental, project and study team meetings as an individual contributor
When requested, provide guidance to other members of the R&D and Pharmacovigilance Quality team.
Your profile:
Bachelor's degree in Sciences
Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results
Skilled in influencing others within a global matrix organization and driving informed decision–making
Capable of prioritizing and focusing on critical issues using a risk-based approach
Manage quality and compliance issues with diligence, rigor, transparency and timeliness
Demonstrate strong analytical skills with experience in analyzing and synthesizing complex data
Fluency in French & English
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]
Be the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) to allow assessment.
Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, QuickScore) and track the vendor’s performance
Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging.
Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL’s on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
As required provide Operational QA support to vendors for process, equipment and facilities qualification and project support
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Acts as a coach for VQL’s with less experience.
Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process
Act as coach for the direct reports, perform personal development discussions and manage year-end evaluations and objectives setting (if applicable).
Oversee the VQL activities performed by the direct reports (if applicable).
Your profile:
Master's Degree in Sciences
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
Possess good auditing capabilities and skills
Must have the ability to manage projects/ activities across global geographies within the area of expertise.
Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
Root cause and risk management/assessment skills Problem Solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
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]
Autonomously manage and execute daily laboratory activities related to method development, validation, and transfers.
Contribute to release and stability testing in relation to the project, as appropriate.
Prepare, review, and approve documentation (procedures, protocols, reports).
Analyze experimental results.
Verify data accuracy.
Present and discuss results in project team meetings.
Perform all activities in compliance with GMP/HSE rules and regulatory requirements for each development phase of the product.
Your Profile
Master’s or Bachelor’s degree in biochemistry or analytical chemistry.
Proven expertise, preferably in the biotech industry.
Strong, proven laboratory skills.
Good knowledge of protein chemistry and techniques for separating polymers in a protein matrix.
Practical experience and expertise in at least one of the following analytical techniques:
Chromatography (Size-exclusion, Reverse-phase, Affinity, Ion exchange, HILIC, or HIC).
Electrophoresis (Capillary: CGE, CzE, iCE, or MauriCE).
Expertise in analytical method development and validation.
Ability to work autonomously in day-to-day tasks.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
A good knowledge of GLP/GMP rules is a plus.
Good English skills (both written and oral) are recommended for reports and communication.
Ability to manage multiple priorities and prioritize effectively.
Strong interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
Ability to work in a matrix and customer-oriented environment.
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]
Primary packaging systems innovation and new products development management :
New primary packaging systems development management in line with the strategy, “Pipeline Devices & Delivery Systems” and technologic/scientific platforms objectives and according to established working processes.
Clinical medical devices design and assessment
Primary packaging systems life cycle & sustaining management :
Primary packaging systems sustaining and life cycle management coordination and support to all operation sites and CMO’s.
Competitors pharmaceuticals primary packaging systems benchmarking management :
Competitors primary packaging systems portfolio analyze & characterization.
Primary packaging materials, components and technology scouting and assessment according to defined priorities
Planning, implementation and documentation to maintain and set up the systems (processes, resources, equipment) of the organizational unit
Where applicable: maintenance of and responsibility for the SOP processes assigned to the unit and direct sub-processes thereof
The job holder informs his superior about significant changes and progress without delay on a regular basis and in emergencies.
Within the unit and/or projects the job holder ensures that the internal regulations and the national laws and ordinances concerning occupational safety, accident prevention, waste removal and disposal, and environmental protection are observed
In the planning, performance and documentation of his work within the unit the job holder ensures that the applicable internal rules (Standard Operating Instructions, SOP) and the applicable national and international laws, regulations and directives are observed
The job holder participates in the necessary training defined for his job, e.g. SOP training sessions, GMP training sessions, projects management, technical/scientific trainings, conferences, etc
Your profile:
Minimum of 5 years working in the pharmaceutical/biologics/medical primary packaging industry. Operational GMP or quality experience would be a distinct advantage
Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur. and JP standards, Food-contact legislations
Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems
Pharmaceutical business experience and familiarity with competitive landscape of primary packaging development process, regulatory requirements
Experience in global projects, ideally with USA or EU operational, HS&E processes and procedures
Proven track record in project management / Project Management certification will be a distinct advantage
Fluency in French & English
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]
Coordinate qualification and validation activities for cleaning equipment (e.g., washers, COP stations).
Manage change controls and deviations using the Viva system (internal training provided).
Support the qualification of new equipment and validation activities by coordinating with production and support teams (e.g., ensuring availability of materials and personnel).
Collaborate with a Process Engineer on Washer and COP/SOP-related activities.
Participate in the review of validation protocols, test sheets, and reports.
Conduct regular on-site follow-ups and coordinate with production and automation teams.
Provide support during layout activities and machine qualification for the summer shutdown.
Documentation Responsibilities
Write and manage operational procedures (SOPs).
Draft and follow up on change controls and deviations.
Write URS (User Requirement Specifications) and Design Verification (DV) documents.
Review and approve qualification documentation as needed.
Your Profile
3 to 7 years of experience in qualification/validation or production within the pharmaceutical industry, ideally in sterile manufacturing.
Strong knowledge of Good Manufacturing Practices (GMP).
Proven coordination skills and ability to track qualification activities.
Experience in deviation and change control management.
Basic understanding of CSV qualification and automation processes.
Experience with cleaning systems (CIP/SIP) and automation tools (e.g., AVEVA) is a plus.
Familiarity with layout planning, equipment installation, and project management tools (e.g., MS Project, Excel).
Project management skills using MS Project or Excel.
Fluent in French, with strong English writing skills.
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]
Package owner : Supplier management, equipment final design, execution and qualification, P&ID tracking, electrical schematics, project execution (planning, coordination,….).
Your profile:
Master’s degree
Minimum 5 years of experience within pharmaceutical companies and working with Engineering offices
Requires project management experience in pharma, knowledge of qualification, and equipment design.
Experience: Preferably in CAPEX projects within a commercial GMP facility.
Good Upstream and Downstream Process Technical expertise.
Good knowledge in automated system.
Good Knowledge of cGxP requirments.
Automation: Siemens PCS7 knowledge beneficial; the role involves verifying compliance with software requirements.
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]
