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Project Engineer

Company: SHL Medical
Location: Deerfield Beach
Posted on: August 1, 2022

Job Description:

We have an immediate opening for a Project Engineer at our Deerfield Beach, Florida headquarters.
Our company provides final assembly, labeling, and packaging services of drug delivery devices to the pharmaceutical and biotechnology industries and soon clinical fill-finish capabilities. Scientists and Engineers work closely with our partners to continuously create and introduce innovative, patient-centric solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their partner company counterparts to develop and maintain program timelines in line with our partners' strategic and business needs. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved and have one clear point of responsibility.
Job Overview:Manage and coordinate internal (non-customer) Process Development projects, reporting to the PD Director.
Project Engineers are responsible for successful project execution, while ensuring that all activities are completed and documented in accordance with SHL Pharma Quality System requirements. Project Engineers are cross-functional project leaders, working closely with various departments, internal stakeholders, and suppliers to ensure that project requirements and timeline are on track. Project types include but are not limited to the commissioning and qualification of facility, testing, final assembly, labeling, packaging, and serialization equipment for device platforms.
Main Responsibilities:

  • Define project scope, deliverables, and major milestones in partnership with stakeholders. Manage and communicate any changes to the project team and stakeholders.
  • Define project requirements, priorities, and timeline.
  • Prepare budget based on scope of work and track project costs.
  • Forecast resources needed to meet the project timeline and assemble a project team with the appropriate skills to do so.
  • Develop a detailed project schedule and activity list with the project team to track activities. Regularly update and review schedule with suppliers, stakeholders, and project team.
  • Proactively identify, prevent, minimize, and manage project risks, escalating risks to the appropriate stakeholders as early as possible. Identify and propose solutions to address risks.
  • Plan and order material needed to execute the project, in accordance with the project timeline.
  • Monitor and ensure documentation are on time, complete, and in accordance with SHL Pharma Quality System requirements.
  • Lead design reviews with equipment suppliers for process layout, optimization, and equipment development.
  • Review new equipment design documentation (e.g. User Requirements, Functional Specification, Hardware & Software Design Specification, etc.)
  • Support the complete project lifecycle such as FAT and SAT with the equipment supplier.
  • Coordinate cross-functional internal resources and third parties/vendors for timely execution of the project.
  • Support the project team through root cause analysis to conduct investigations, Non-conformance Reports (NCR), Corrective and Preventive Actions (CAPA), etc.
  • Model leadership skills by taking extreme accountability/ownership for their own projects, as well as other projects as needed based on resource availability.
  • Identify opportunities for continuous improvement and support the execution and implementation of LEAN projects within PD.
  • Comply with all quality, safety, and industry regulations.
    Skills and Qualification:
    • B.S. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study is preferred.
    • 3+ years of experience in project management or lead technical role is required.
    • Proficient knowledge of project management processes, methods, and tools is required, especially regarding timelines and budgets is required.
    • Proficient time, risk, stakeholder, and change management skills are required.
    • Proficient in identifying and implementing LEAN opportunities is required.
    • Knowledge of industry practices and guidelines including those outlined by the FDA, ISO, OSHA, GAMP5, and ASTM is preferred.
    • Knowledge of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) is required.
    • Knowledge of mechanical design principles, testing, and manufacturing processes, as well as DFM/DFA is required.
    • Proficiency in Microsoft Excel and Microsoft Word is required.
    • Ability to lead teams effectively is required.
    • Ability to work independently is required.
    • Effective communication (written and verbal) and collaboration within cross-functional teams are required.
      The physical demands described here are representative of those that must be met by and 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. While performing the duties of this job, the employee is regularly required to use hands to handle or feel objects, tools, or controls; reach with hands and arms; stoop, kneel or crouch. Specific vision abilities required by this job include close vision, and the ability to adjust focus.
      We have an excellent benefits package and offer a salary that is based on experience and accomplishments.
      If you possess the required experience and qualifications and want the challenge of growing with our company, then submit your resume in confidence to our Talent Acquisition Department at RecruitCH@shl-group.com

Keywords: SHL Medical, Deerfield Beach , Project Engineer, Engineering , Deerfield Beach, Florida

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