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Chemical / Process Engineer
North Brunswick Township, NJ

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Ascendia Pharmaceutical Solutions

Pharmaceutical Process Engineer

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Job Description

We are seeking a motivated Pharmaceutical Process Engineer to support the development, scale-up, and execution of pharmaceutical manufacturing processes. This is an excellent opportunity for a recent graduate or early-career engineer interested in applying chemical and pharmaceutical engineering principles to drug product development and manufacturing. The successful candidate will work closely with formulation scientists, analytical scientists, and manufacturing personnel to support laboratory and pilot-scale processing, equipment operation, process development, scale-up, and GMP manufacturing activities. Key Responsibilities
  • Support the development, optimization, scale-up, and execution of pharmaceutical manufacturing processes.
  • Assist with laboratory, pilot-scale, and GMP manufacturing activities for pharmaceutical drug products.
  • Operate and support pharmaceutical processing equipment and unit operations such as: o Mixing and homogenization o High-shear processing o Milling and particle-size reduction o Filtration o Granulation and drying o Blending o Encapsulation and/or tableting. o Solution and suspension preparation o Aseptic or controlled-environment processing, as applicable.
  • Assist scientists and engineers with non-aseptic and aseptic process development, process troubleshooting, and identification of process improvements.
  • Support equipment setup, cleaning, operation, and maintenance activities.
  • Collect, organize, analyze, and interpret process and manufacturing data.
  • Assist with equipment qualification, process characterization, technology transfer, and scale-up activities.
  • Prepare and review technical documentation, including experimental protocols, batch records, equipment logs, cleaning procedures, sterilization procedures, development reports, and standard operating procedures (SOPs).
  • Execute work in accordance with established procedures, Good Manufacturing Practices (GMP), and applicable safety requirements.
  • Maintain accurate, complete, and contemporaneous documentation of experimental and manufacturing activities.
  • Collaborate effectively with Formulation Development, Analytical Development, Manufacturing, Quality, and other cross-functional teams.
  • Participate in investigations and troubleshooting related to equipment, processes, and manufacturing operations.
  • Maintain laboratory and processing areas in a safe, organized, and inspection-ready condition. Qualifications Required
  • BS or MS in Chemical Engineering, Pharmaceutical Engineering , or a closely related engineering discipline.
  • 0-2 years of relevant academic, internship, co-op, or pharmaceutical/biotechnology industry experience.
  • Familiarity with fundamental chemical engineering principles and pharmaceutical unit operations.
  • Basic understanding of Good Manufacturing Practices (GMP) and controlled manufacturing environments.
  • Experience in and understanding aseptic manufacturing
  • Interest in hands-on laboratory and manufacturing work, including operation of processing equipment.
  • Strong problem-solving and analytical skills.
  • Ability to accurately document experimental and manufacturing activities.
  • Strong organizational skills and attention to detail.
  • Ability to work effectively both independently and as part of a multidisciplinary team.
  • Effective written and verbal communication skills. Preferred
  • Internship, co-op, research, or academic laboratory experience involving pharmaceutical processing or manufacturing.
  • Firsthand experience with mixing, homogenization, milling, filtration, drying, granulation, blending, or other pharmaceutical unit operations.
  • Familiarity with pharmaceutical dosage forms such as oral solids, solutions, suspensions, injectables, or other drug delivery systems.
  • Exposure to GMP documentation, batch records, SOPs, deviations, CAPAs, or equipment qualification.
  • Experience collecting and analyzing process data and preparing technical reports.
  • Familiarity with process scale-up, Design of Experiments (DOE), or Quality by Design (QbD) concepts is a plus, especially in aseptic environments.
Ideal Candidate The ideal candidate is a hands-on engineer who enjoys working at the interface of engineering, formulation science, and pharmaceutical manufacturing . This individual is comfortable working with equipment, learning new processes, troubleshooting problems, and spending considerable time in the laboratory or manufacturing environment rather than working exclusively at a desk. We are particularly interested in candidates who are curious, meticulous, willing to learn, and excited about developing a solid foundation in pharmaceutical process development and GMP manufacturing. Company Overview Ascendia Pharmaceuticals is a specialty pharmaceutical company dedicated to developing advanced formulations of existing drug products and supporting pre-clinical and clinical stage drug candidates. The organization leverages innovative technologies such as nano-emulsions, amorphous solid dispersions, and nano-particles to enhance drug bioavailability and solubility, providing comprehensive development solutions from discovery to lifecycle management. Join our innovative team as a Pharmaceutical Process Engineer where your expertise will directly impact the development of life-changing therapies through advanced formulation processes!
Pay:
$60,000.00 - $80,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance
Work Location:
In person

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Health Insurance
  • Dental Insurance