Lead Technical Operations - Process & Cleaning Validation
Locations: Beerse, Belgium
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Requisition ID: 1905769894W
Purpose of the function:
You are a member of the Local Technical Operations Team, you lead the Validation Team and you are the accountable person for the issuing of and the adherence to the Process & Cleaning Validation Master Plan (VMP) within the Beerse and Olen manufacturing area (ie. Liquids and Creams, Parenterals, Eye care products, Transdermals and Pellets).
In scope are: new product introductions (NPI), life cycle management (LCM), validation, process improvements, standards and new technology deployment.
You define process validation strategy, you manage your team and you coordinate and keep oversight of activities in accordance with cGMP-guidelines and the applicable guidelines in order to support flawless manufacturing operations.
As function holder you are
* Responsible for the management, development and determination of the goals & objectives of your team (about 10 employees).
* Responsible for management and follow up of the Validation Master Planning.
* Responsible to maintain the validation processes of manufacturing and cleaning processes in support of new, transferred and existing products and systems up to current standards through definition & maintenance of contemporary methodologies & standards in order to support commercial manufacturing and testing and strive for continuous improvement.
* Responsible to continuously scout for opportunities in close cooperation with the sites to identify projects to improve the manufacturing network performance and to optimize cost of goods.
* Local process owner for process, cleaning validation.
* Principal SME for validation approach and standards hence also spokesperson for these topics during inspections.
* Responsible for standardization of the validation approach throughout the projects and the area's.
* The lead of global teams related to validation (COE cleaning and sanitization, Global Pharma cleaning validation team; aseptic manufacturing team, benchmark sterilization validation, …)
* * The local implementation lead of global initiatives and responsible for roll out in the site (CPV, PPQ, …).
* * The owner/lead or you participate in the CPV (continued process verification) program by issuing plans, protocols and reports and oversee the execution.
* The project lead (preferably) using FPX methodology to implement projects within the validation area.
* Contributing to DESIGN TO VALUE AND PLATFORM STANDARDISATION:
* You support the development of manufacturing models for Liquids & Creams/Parenterals and Solid technologies part of Design to Value.
* You own the local standard for validation (process, cleaning and sterilization).
Providing required manufacturing technical support, document technical input, review and approval and serving as the JSC technical expert in the validation area.
Responsible for selection of the adequate (statistical) techniques and related applications (ie. peer reviews, authorship and management etc) in the validation domain.
Optimizing the new product introduction process, making use of JSC technology platforms, accelerating development timelines, streamlining the technical transfer process.
Supporting inspection readiness.
Identifying/leading and contributing to process improvement projects, including new technology introduction (e.g. PAT).
You may be suitable for the job if you:
* Have a Master degree in Engineering or Science or equivalent.
* Have strong interest and technical knowledge in:
* pharmaceutical manufacturing processes & products and/or equipment engineering.
* the area of validation.
* Quality & Compliance / regulatory requirements (GMP/EH&S) especially for the involved technology platform.
* introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations.
* knowledge of manufacturing site systems and procedures
* preferably project management (FPX or other) and Process excellence (6sigma), lean concepts and tools.
* preferably quantitative degree in and/or certified in and/or appropriate training in statistics.
Have following personal and interpersonal skills / leadership skills:
* Ability to lead cross functional / cross-region project team.
* Ability to manage complexity and change and to work under pressure, handle conflicting interests, and take decisions.
* Ability to interact at different levels of the organization.
* Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
* Ability to create a result oriented (project) team.
* Customer and business focus.
* Team player with positive mindset and with problem solving skills and attitude.
Janssen Pharmaceutica N.V. (7555)