SENIOR PROJECT ENGINEER
Company: Formulated Solutions
Location: Cleveland
Posted on: September 28, 2024
Job Description:
PRIMARY PURPOSE:
Completes engineering projects of varying scopes under the
direction of senior engineers/management by organizing and
controlling project elements. Support larger projects through
detailed design and execution of smaller project deliverables.
MAJOR DUTIES AND RESPONSIBILITIES INCLUDE:
- Determine project specifications by defining the user
requirements including manufacturing equipment purchase/upgrades
and/or change parts requirements.
- Work with equipment and outside vendors to define user
requirements and develop quotes.
- Collaborate with other departments including Procurement, SHE,
Operations, Maintenance, Quality Control to ensure cross functional
agreement during project execution.
- Develop preliminary project scope and order of magnitude
estimate.
- Present business case and obtain capital funding through
capital request procedure.
- Develop final detailed scope and parameters for project design
and implementation.
- Develop project schedule and delineate project
responsibilities.
- Complete detailed design including CAD layouts and
instrumentation specifications.
- Develop Design Specification/ Design Qualification
Documents
- Construction management including defining constraints,
procedures, data collection methods, and performance standards
within boundaries of corporate policy.
- Development management of change document as required
- Prepare scheduled and necessary updates of construction
activities and analysis of manpower and equipment required.
- Create and Execute Factory Acceptance Testing, Site
Commissioning Documents and Installation/Operational Qualification
Documents (as applicable)
- Create and administer appropriate metrics to monitor project
performance.
- Inform all supervisors and subcontractors promptly of any
construction schedule changes, and work closely with all
stakeholders to ensure requirements are met.
- Maintain budgetary, scheduling, and project database oversight,
and report regularly to project manager to keep him/her constantly
informed of job progress, plans and problems that could
significantly affect costs or schedules.
- Manage compliance, quality control, and quality assurance
standards and specifications.
- Participate in deviation investigations, problem solving
activities, and continuous improvement activities as required.
- Write Work Instructions, NOE's, Risk Assessments, Deviations,
SOP's as needed. QUALIFICATION:
Required
- Bachelor's degree in Chemical, Electrical, or Mechanical
Engineering or related field of study.
- Strong field management experience
- Project engineering experience
- Must be able to lift 20 pounds on a regular basis
- 5 -7 years experience in consumer OTC/healthcare packaging or
related industry Preferred Additional
- Background in or working knowledge of pharmaceutical industry
and cGMP's preferable.
CRITICAL SKILLS AND ABILITIES:
- Strong working knowledge of design software, including
AutoCAD
- Proven understanding of compliance and quality assurance
guidelines and best practices COMPUTER SKILLS:
- Ability to operate the following office equipment: computer,
telephone, photocopier, facsimile, and calculator.
- Power Point, Word, Excel, and a basic understanding of
Microsoft media applications is required. Technical Skills and
Experience (if applicable):
- Technical skills appropriate for execution of technical
transfers of topical products
- Data analysis with a good understanding of statistical process
control Education and/or Training
- Bachelor's degree in Chemical, Electrical, or Mechanical
Engineering or related field.
Keywords: Formulated Solutions, Cleveland , SENIOR PROJECT ENGINEER, Engineering , Cleveland, Tennessee
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