Pr Eng Rd External Supply Integration
il y a 4 semaines
J&J Innovative Medicine is recruiting for a Principal Engineer, located in Beerse, Belgium
The Principal Engineer is leading drug product supplies and assuring timely delivery of clinical trial material from the DPDS CMO network. They will partner with other functions CSC/DPDS, JSC, JRP and QA to assure all logístical, quality & technical elements are in place for RFT delivery. They will identify and implement new technology platforms, influence vendor selection/identification/management and assure equipment/facility readiness. Additionally, they partner with the value streams on PF2P, scale up and tech transfer.
**Key Responsibilities**:
- Process Engineering expertise which influence the Drug Product Development team operational practices and challenging the demand planning resulting in efficiency, cost avoidance, optimization of capabilities,
- Due diligence assessments of CMO for manufacture, including equipment and facility assessments to confirm capability for formulation, fill finish and clinical packaging.
- E2E responsibility for the manufacture meeting the clinical demand schedule.
- Tech Transfer support includes commercial plant readiness for registration, launch and commercial production, DoE & Scale-up support
**Qualifications**:
**Qualifications**:
**Education**:
- A higher technical education level BA/BS or equivalent experience, MA/MBA preferred
**Experience and Skills**:
**Required**:
**Compliance responsibilities**:
A consistent track record to work in a highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines) is required. Being advised about applicable internal and external rules (guidelines, laws ) with respect to requirements for equipment and relevant processes (literature, workshops, seminars ).
**Project management**:
Project management skills must be applied in all projects related to the following responsibilities:
- Process
- and SHE-integrated approach (site risk assessment, IOQ, PQ, Cleaning Validation,) cross-linked and aligned with QA, Development and Manufacturing
- Giving input as business lead into Master Service Agreement with external partner, defining Scope of Work, coordinating periodic review and score card monitoring.
- Coordinate orders and invoicing according to project plan and taking the lead in projects, FTE and budget planning
**Budget responsibilities**:
Leading dedicated operational and project budget including full control of budget and cost during project realization and able to present to senior management and finance.
**Personnel responsibilities**:
**External contacts**:
Build partnership with Contract Manufacturing Organizations to perform capability assessments and provide multiple disciplinary technical expertise’s to influence and bridge gap analysis to meet Clinical Trial requirements.
For small as well as for large projects, extensive contacts with different suppliers/contractors can be vital to achieve the required project results. This means mutual exchange of information e.g. leading confidentiality agreements, applicable internal standards, user & process specifications, functional specifications and product information.
Benchmarking and updating internal knowledge mean contact with and information exchanges with other pharmaceutical companies during workshops, seminars
**Internal contacts**:
Main clients are Pharmaceutical Development and Clinical Supplies in addition to the JSC MSAT and PES organizations. In order to understand their needs, frequent contacts with SME’s are very meaningful for project definition and progress.
Contacts with all members of the project team of the different involved departments are common (i.e. Quality Assurance, Scientific Integrators, Clinical Supply Integrator, PES, MSAT, Packaging Engineering)
Frequent review meetings with DP Plant Owners and API supply for sourcing decisions and updates on projects
**Preferred**:
- Knowledge in oral solids and liquid process and technology systems
- Knowledge of sterilization technology, parenteral processes including fill/finish
- Specific expertise: Clinical Manufacturing, Process Engineering & Scale-up, Pack & Label and Process Analytical Technology.
- People leadership skills
**Other**:
- Excellent knowledge of English (spoken and written)
- About 30% international travel is needed to support this job.
- Elementary know how on the following will be an advantage : Facilities, HVAC and Utilities, Isolator, cleanroom technology and high containment systems.
- Specific experience will bring contributed : Equipment qualification, validation and change control systems, Batch record review, IPC and monitoring systems, good documentation practices
- Specific tools such as ATS (analytical trouble shooting), PE (process excellence tools), Planning tools (MS-project), data acquisition systems,...
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for e
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