Process Development Engineer

4 days ago


Kingston, Ontario, Canada Alcami Full time

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization. Our team works closely with clients to provide trusted partnership and recognized industry expertise.

Job Summary

The Senior Process Engineer is responsible for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing at our RTP facility. Key responsibilities include:

  • Performing tech transfers of new processes and technologies into the site
  • Preparing documentation to support process validation and batch manufacturing
  • Troubleshooting manufacturing processes
  • Completing process deviations and investigations
  • Coordinating lab studies with the formulation development lab

These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

On-Site Expectations

  • 100% on-site position
  • 1st Shift: Monday - Friday, 8:00am - 5:00pm
Responsibilities

The Senior Process Engineer will:

  • Provide technical assistance for process tech transfer and validation efforts for assigned manufacturing projects
  • Write Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
  • Monitor manufacturing processes during production runs to assess any technical process issues and provide troubleshooting support as needed
  • Autorize manufacturing investigations and complete CAPA assignments
  • Compose process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols
  • Identify specific parameters, sampling, and tests used in the validation protocols of new and existing products
  • Interact with clients during routinely scheduled project meetings
  • Ensure timely completion and compliance with cGMP and all other relevant company training requirements

Qualifications

  • Bachelor's degree in Engineering, Pharmacy, or Chemistry
  • 5 years of experience of technical support in a sterile pharmaceutical manufacturing environment
  • Previous experience supporting tech transfer of parenteral Drug Products preferred
Knowledge, Skills, and Abilities

The ideal candidate will have:

  • Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required
  • Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes
  • Working knowledge of EU regulations preferred
  • Proficiency with Microsoft office (Word, Excel, Outlook) required
  • Ability to interact with internal stakeholders and external customers

Travel Expectations

  • Up to 5% domestic travel

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



  • Kingston, Ontario, Canada Canada Royal Milk Full time

    About UsAt Canada Royal Milk, we balance innovation and tradition to deliver high-quality dairy products to customers around the world.We're a leader in the dairy industry, known for our commitment to quality, sustainability, and continuous improvement. Our employees are passionate about their work and dedicated to delivering exceptional results.This role...


  • Kingston, Ontario, Canada Alcami Full time

    About us: Alcami delivers reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.We're looking for a skilled Manufacturing Technician II to join our team in a fast-paced environment. In this...


  • Kingston, Ontario, Canada Alcami Full time

    Alcami is a leading contract development and manufacturing organization (CDMO) dedicated to helping pharmaceutical and biotechnology companies bring innovative therapies to market. We are seeking a highly skilled Senior Process Engineer to join our team at our RTP facility.About the PositionThe Senior Process Engineer will be responsible for:Providing...

  • Automation Engineer

    1 week ago


    Kingston, Ontario, Canada Canada Royal Milk Full time

    Welcome to Canada Royal Milk, where innovation meets tradition. We're a leading force in the dairy industry, known for our commitment to quality, sustainability, and cutting-edge technology. As an Electrical Automation Engineer, you'll be at the heart of our operations, ensuring everything runs smoothly and efficiently. You'll bring your expertise to...


  • Kingston, Ontario, Canada TPD® Workforce Solutions Full time

    Mechanical Engineer Kingston, ON Fulltime, Permanent Our client, Haakon Industries, a rapidly expanding manufacturer of high-end custom air handling equipment renowned for quality and reliability, with products in high demand across North America's top companies and critical facilities like hospitals and manufacturing plants, is seeking a talented ...


  • Kingston, Ontario, Canada Canada Royal Milk Full time

    Key ResponsibilitiesWe're looking for an Automation Systems Engineer to join our team at Canada Royal Milk. As a key member of our operations team, you'll be responsible for ensuring the efficient operation of our manufacturing process.Responsibilities include:Designing and implementing automated systems to improve manufacturing efficiencyDeveloping and...


  • Kingston, Ontario, Canada Hazelett Corporation Full time

    Our preferred candidate for Electrical Engineer – Industrial Automation is successful in implementing automation system projects by understanding customer requirements, product line needs, and control system architecture. Primary responsibilities include developing comprehensive and robust PLC logic, intuitive HMI screens, clear and concise electrical...


  • Kingston, Ontario, Canada TalentSphere Staffing Solutions Full time

    Position: Structural Engineer Location: Kingston, ONSalary: $90,000 - $100,000 + (based on experience)Overview: An established multi-disciplinary Engineering Consulting firm is seeking a dedicated and skilled Structural Engineer to join its dynamic team. With a welcoming office environment, flexible work schedules, and a commitment to fostering...


  • Kingston, Ontario, Canada TalentSphere Staffing Solutions Full time

    Position: Electrical Engineer Location: Kingston, ONSalary: $90,000 - $100,000 + (based on experience)Overview: An established multi-disciplinary Engineering Consulting firm is seeking a dedicated and skilled Electrical Engineer to join its dynamic team. With a welcoming office environment, flexible work schedules, and a commitment to fostering professional...


  • Kingston, Ontario, Canada TalentSphere Staffing Solutions Full time

    Position: Mechanical EngineerLocation: Kingston, ONSalary: $90,000 - $100,000 + (based on experience)Overview: An established multi-disciplinary Engineering Consulting firm is seeking a dedicated and skilled Mechanical Engineer to join its dynamic team. With a welcoming office environment, flexible work schedules, and a commitment to fostering professional...

  • Cloud Engineer

    3 weeks ago


    Kingston, Ontario, Canada Novari Health Full time

    The Cloud Engineer is responsible for optimizing and controlling cloud costs within the organization by executing on initiatives aimed at cost reduction and efficiency. This role involves actively contributing to the management of cloud expenditures through tasks such as cost reporting, cost avoidance strategies, forecasting, and capacity planning. The Cloud...

  • Cloud Engineer

    16 hours ago


    Kingston, Ontario, Canada Novari Health Full time

    The Cloud Engineer is responsible for optimizing and controlling cloud costs within the organization by executing on initiatives aimed at cost reduction and efficiency. This role involves actively contributing to the management of cloud expenditures through tasks such as cost reporting, cost avoidance strategies, forecasting, and capacity planning. The Cloud...


  • Kingston, Ontario, Canada EngSoc Full time

    Engineers of Tomorrow (EoT) is a non-profit organization that matches engineers with classrooms across Canada to teach youth about engineering. The EoT Queen's Chapter is the first ever university branch of the organization ratified under EngSoc, and we aim to propagate this initiative using outreach to teens and high school students We are...


  • Kingston, Ontario, Canada EngSoc Full time

    Engineers of Tomorrow (EoT) is a non-profit organization that matches engineers with classrooms across Canada to teach youth about engineering. The EoT Queen's Chapter is the first ever university branch of the organization ratified under EngSoc, and we aim to propagate this initiative using outreach to teens and high school students We are...

  • Mechanical Engineer

    3 weeks ago


    Kingston, Ontario, Canada Modern Technical Staffing Inc. Full time

    Mechanical Engineer Our client is a well-established multidisciplinary engineering firm that specializes in land development engineering, structural engineering, and building services (mechanical and electrical). They are looking for a Mechanical Engineer to join their team on a permanent basis in Kingston on a hybrid/remote basis. Role and...

  • Mechanical Engineer

    1 week ago


    Kingston, Ontario, Canada Modern Technical Staffing Inc. Full time

    Mechanical EngineerOur client is a well-established multidisciplinary engineering firm that specializes in land development engineering, structural engineering, and building services (mechanical and electrical). They are looking for a Mechanical Engineer to join their team on a permanent basis in Kingston on a hybrid/remote basis.Role and...

  • Software Engineer

    4 weeks ago


    Kingston, Ontario, Canada Qualitest Full time

    Software Engineer - Embedded Linux and Yocto DevelopmentWe are looking for a highly skilled Software Engineer to join our team in Indianola, PA, United States. As a key member of our engineering team, you will be responsible for developing, modifying, and maintaining Linux kernel drivers using C and creating robust and efficient applications for embedded...

  • Electrical Engineer

    2 weeks ago


    Kingston, Ontario, Canada Modern Technical Staffing Inc. Full time

    Our client is a well-established multidisciplinary engineering firm that specializes in land development engineering, structural engineering, and building services (mechanical and electrical). They are looking for an Electrical Engineer to join their team on a permanent basis in Kingston. Responsibilities Planning, design, execution, and completion of...

  • Electrical Engineer

    3 weeks ago


    Kingston, Ontario, Canada Modern Technical Staffing Inc. Full time

    Our client is a well-established multidisciplinary engineering firm that specializes in land development engineering, structural engineering, and building services (mechanical and electrical). They are looking for an Electrical Engineer to join their team on a permanent basis in Kingston. Responsibilities Planning, design, execution, and completion of...

  • Structural Engineer

    3 weeks ago


    Kingston, Ontario, Canada Modern Technical Staffing Inc. Full time

    Structural Engineer Our client is a well-established multidisciplinary engineering firm that specializes in land development engineering, structural engineering, and building services (mechanical and electrical). They are looking for a Structural Engineer to join their team on a permanent basis in Kingston on a hybrid/remote basis. Role and...