Company: SHL Medical
Location: Deerfield Beach
Posted on: August 1, 2022
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.
- 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
- 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
- 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
- Proficient time, risk, stakeholder, and change management
skills are required.
- Proficient in identifying and implementing LEAN opportunities
- 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
- Knowledge of mechanical design principles, testing, and
manufacturing processes, as well as DFM/DFA is required.
- Proficiency in Microsoft Excel and Microsoft Word is
- 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
Keywords: SHL Medical, Deerfield Beach , Project Engineer, Engineering , Deerfield Beach, Florida
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