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Argenta · 2 months ago

Senior Engineer

Shawnee, Kansas, United States

Full-time

Onsite

Senior Level

Argenta is a global team dedicated to healthier animals, supporting companies in developing health products for pets and livestock. The Senior Engineer role involves developing and implementing manufacturing process solutions, leading projects, and providing engineering support for production and process equipment.

ManufacturingMedicalPharmaceuticalVeterinary

Responsibilities

Makes independent decisions within defined areas of responsibility. Serves as a consultant to management within a specified areas/discipline. Advance technical project proposals to senior management, following through successful completion. Influences commitment of resources at divisional / departmental level

Continuously improve and support existing production equipment to support the efficient operation of the Argenta production facility

Manage capital projects, develop and track budgets

Interface with internal and external resources to facilitate the transfer of process knowledge to the manufacturing environment

Ensure that all Engineering activities within the area of responsibility adhere to all applicable engineering standards, codes, cGMP’s, FDA and EU guidelines, safety and environmental procedures

Reviews and approves standard operating procedures describing validation principles and activities

Participate with completing risk analyses for qualifications and validations with participation of Quality, Production and MEU

Actively participates during all phases of equipment life cycle by supporting the development of specifications, design and installation of equipment, systems, facilities, and utilities, and processes to ensure compliance to cGMP requirements

Provides guidance and technical information to others, supporting and/or execution of IQ/SAT

Actively participates in Engineering, functional testing in OQ, and coordination and testing during PQ, PV, and CV activities

Other duties as assigned by the supervisor

Qualification

Pharmaceutical regulationsOral Solid Dosage (OSD)Process Analytical Technology (PAT)Engineering principlesProject managementComputer proficiencyCreative problem solvingCollaboration skillsWritten communicationVerbal communicationOrganizational skills

Required

Bachelor's degree in Engineering

Strong knowledge of pharmaceutical regulations and cGMP standards (FDA, EMA, EU)

Solid understanding of pharmaceutical manufacturing principles, with specific expertise in Oral Solid Dosage (OSD) facility and process design—including formulation, blending, granulation, compression, coating, and packaging operations

Demonstrated experience providing subject matter expertise in OSD technologies, supporting regulatory strategy, technology transfer, and commercialization readiness

Proven ability to collaborate with clients and cross-functional project teams to ensure OSD solutions meet regulatory and operational requirements

Experience with advanced OSD technologies such as continuous manufacturing, Process Analytical Technology (PAT), and high-potency containment systems

Comprehensive knowledge of current pharmaceutical technologies, installation practices, and problem-solving methodologies to effectively direct technical teams

Strong working knowledge of pharmaceutical manufacturing equipment, unit operations, and processing, with expertise in Oral Solid Dosage (OSD) products—including mixing, blending, granulation, milling, tablet compression, and piece-forming technologies

Proven experience in the practical application of engineering principles within a pharmaceutical manufacturing environment

Solid understanding of GMP regulations as interpreted by the FDA, EU, and CVM, along with familiarity with OSHA health and safety and EPA environmental requirements

Demonstrated ability in creative problem solving, as well as tactical and strategic decision-making

Excellent written, verbal, and organizational skills, with the ability to collaborate effectively across internal teams and with external partners

Strong understanding of factory processes, process engineering fundamentals, and process safety requirements

Proficiency in computer systems and software tools relevant to engineering and manufacturing operations