Sr. Process Engineer – Parenteral/Liquid Sterile with Endeavor Consulting Group – Endeavor Consulting Group – Lakewood, NJ, USA
Endeavor Consulting Group is currently driving a project at one of its client’s which focuses in Pharmaceutical Development & Manufacturing Sciences as part of their global Research & Development organization. In order to help our client achieve one of it’s projects, we are currently recruiting for a Process & Technology Transfer Engineer – Drug Product Clinical Supply Chain within our PA/NJ service area. Our client Clinical Supply Chain holds the global responsibility of all clinical supplies of Research & Development. Their activities includes all in-house and outsourced planning, manufacturing and distribution of clinical supplies (API, Drug Product, Packaged Clinical Supplies), through a global network.
Their group supplies more than 60.000 patients in more than 300 clinical trials every year. Endeavor Process & Tech Transfer Engineer will be responsible for technology and scale-up support to the Pharmaceutical Development and Technical Integrator group as well as to the Clinical Manufacturing in Pilot Plant, External Contract Manufacturing Organizations activities to provide Parenteral Drug Product for use in global clinical trials. This assignment covers: Process engineering expertise input to the Parenteral Drug Product Development teams. Concept, Design, Installation and Implementation of new equipment and PAT applications.
Support optimizations and / or changes to existing equipment. Due diligence assessments of CMO for clinical trial material manufacture. E2E responsibility for the manufacture of clinical trial material (biologics) meeting the clinical demand schedule. Tech Transfer support includes commercial plant readiness for registration, launch and commercial production, DoE & Scale-up support with primary focuses around biologics for parenteral drug supply.
Compliance responsibilities: Being informed about applicable internal and external rules (guidelines, laws…) with respect to requirements for equipment and relevant processes (literature, workshops, seminars…). Project management: This information/knowledge must be applied in all projects where applicable, hence the following responsibilities: Process- and SHE-integrated approach (V-model, IQ, OQ, PQ, Safety analysis…). Setup of the required cross-linked information platforms (QA, Manufacturing, Prevention, …).The purpose of this job within our client global clinical supply engineering service of their Global Operations organization is to lead and/or assist in the design, development, testing, and support of clinical, commercial, and cold-chain packaging and shipping qualification. This individual will be responsible for designing, performing testing internally and coordinating any testing activities conducted externally.Qualifications A BS/BA is required.
A degree in Chemical, Mechanical or Pharmaceutical Process Engineering or equivalent is highly preferred. A minimum of at least 5 years in pharmaceutical area is required Knowledge of sterilization technology and parenteral processes are required, conventional as well as innovative platforms like lyophilisation, nanomilling, and nasal spray are preferred. Specific expertise: Process Engineering & Scale-up and Manufacturing are required. Understanding of Process Analytical Technology are preferred. Candidate should have knowledge in oral solids processes and/or liquids dosage products, processes and technology systems would be beneficial is preferred. Elementary technical background (mechanics, electrical, PLC, pneumatics, HVAC…) is required. GXP, Regulatory requirements, applicable Standard Operating Procedures, Engineering Technical Standards, Technical Safety Standards, Industrial Hygiene Standards, MS office applications are required. Excellent knowledge of English (spoken and written) is required. Elementary concepts of HVAC-systems is required. Isolator, cleanroom technology and high containment systems is preferred.
Sterile liquids manufacturing systems including compounding and fill finish is required, and pack and label is preferred. Oral solid dose manufacturing systems incl. granulation, compression, coating, pack and label blister and bottle packaging is preferred. IPC and monitoring systems is preferred. Basic concepts of CSV (computer system validation) systems is required. Equipment qualification, validation and change management systems is required. Specific tools such as ATS (analytical trouble shooting), PE (process excellence tools), and Planning tools (MS-project) is preferred. Good documentation practices required.Position is located in Titusville, NJ or Raritan, NJ
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