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Lead Process Engineer

Company: Fraser Dove International
Location: Billerica
Posted on: November 22, 2022

Job Description:

Lead Process Engineer
Are you a driven and adaptable Lead Process Engineer who is ready to serve as a Subject Matter Expert (SME) for various unit operations, especially vial filling line equipment?
Are you looking to work for a rapidly growing organisation who are in the initial phases of growth plans for their engineering department?
Is progression and responsibility key factors you are looking for in your next role?
Fraser Dove International is partnered exclusively with an innovative pharmaceutical organisation specialising in Medical Imaging. Operating internationally, they are committed to creating and providing pioneering medical imaging solutions to improve treatment of human disease.
Our client is seeking a creative leader who is willing to do things differently and drive forward engineering projects.
Discover more about our Lead Process Engineer opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
Your objectives:
As the Lead Process Engineer, you will be measured against the following objectives:1) Develop new manufacturing capabilities and optimize existing manufacturing processes.
2) Lead, perform, or oversee all aspects of assigned projects, including specification, design, selection, installation, commissioning, and qualification.
3) Provide technical support for operations, troubleshooting, repair and maintenance of existing and new manufacturing processes and equipment used in radiopharmaceutical and aseptic manufacturing operations.
What you will do:
As the Lead Process Engineer, your duties and responsibilities will include:

  • Ensure equipment and run readiness of new isolated vial filling line and associated cleaning, sterilization, formulation, inspection, labelling, and support areas.
  • Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions.
  • Lead and execute continuous improvement projects to provide optimal radiopharmaceutical and aseptic manufacturing processes, using defined, data-driven methods to identify, select, and prioritize these projects.
  • Develop and specify new equipment and process capabilities, working closely with aligned groups in Manufacturing, Quality, Facilities and Manufacturing Automation.
  • Prepare project cost estimates and funding requests; work with other groups to obtain required approvals.
  • Manage, coordinate, and oversee development of user requirements for new projects/equipment and coordinate and lead team review of designs/deliverables and document decisions.
  • Inspect or direct the inspection of work to ensure conformance to design drawings, specifications, schedules, and safety regulations.
  • Manage equipment and process validation, either acting as the validation engineer or working with the Validation department.
  • Provide support in the development, review and maintenance of operational SOPs and predictive/preventive maintenance job plans.
  • As a Subject Matter Expert (SME) on the manufacturing equipment, provide technical training to other departments.
    What you will bring: These are the skills and experience you will need to succeed as the Lead Process Engineer:
    • Six or more years of experience in manufacturing of parenteral pharmaceutical products, or an FDA regulated automated manufacturing facility.
    • Prior vial filling line experience.
    • Excellent oral & written communication skills & ability to develop technical presentation materials and present.
    • Demonstrated ability to write and review technical documents.
    • Excellent organizational and time management skills.
    • Strong project management and effective problem-solving skills.
    • Bachelor's Degree in Mechanical, Electrical, Chemical Engineering or related discipline.
      What you will get:
      These are the perks and benefits that will complement your generous base salary:
      • Bonus
      • 3 weeks' vacation
      • 401k
      • Relocation Support
      • Sign-On Bonus
        Got what it takes?
        To apply for the Lead Process Engineer role, click the 'Apply' button below or contact the Executive Search Consultant - Jose Henriques - on +44 (0)203 355 7050.
        Please Note:
        • This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
        • If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.
        • We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website:******Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.

Keywords: Fraser Dove International, Billerica , Lead Process Engineer, Engineering , Billerica, Massachusetts

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