The Role
Leads engineering projects from scope development and cost estimation through detailed design, construction management, testing, and closeout. Develops project plans, schedules, budgets, status reports, and testing protocols; coordinates personnel, subcontractors, and stakeholders; monitors compliance with OSHA, NEC, ASME, NFPA, and site quality standards. Requires field management, engineering project experience, design software proficiency, and the ability to support pharmaceutical, chemical manufacturing, or packaging projects.
Summary Generated by Built In
PRIMARY PURPOSE:
MAJOR DUTIES AND RESPONSIBILITIES:
QUALIFICATION:
CRITICAL SKILLS AND ABILITIES:
Completes engineering projects by organizing and controlling project elements such as scope development, cost estimation, detailed design, construction management, and project closeout meetings.
MAJOR DUTIES AND RESPONSIBILITIES:
- From a problem description, develop high-level scopes including USER REQUIREMENTS that provide solutions to the problem.
- Once high-level scopes are complete, develop order of magnitude (OOM) cost estimates for various solutions.
- Present solutions to Executive Management and get preliminary approval of design concepts before writing the capital request.
- Once approved, develop detailed design parameters for project design
and implementation
- Identify project responsibilities, delegating phases and elements to the appropriate personnel
- Develop and control the full project plan lifecycle
- Assist or act as the construction manager to deliver on project objectives and procedures.
- Prepare schedule and necessary updates of construction activities and analysis of manpower and equipment required
- Monitor both schedule and cost versus approved scope.
- Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
- Create and administer appropriate testing protocols (FAT, SAT, IOQ, etc) to ensure equipment and design performance
- Inform all supervisors and subcontractors promptly of any construction schedule changes, and work closely with all stakeholders to ensure all USER REQUIREMENTS are met within budget and on time.
- Maintain budgetary, scheduling, and project database oversight,
- Ensure compliance of design and project implementation (OSHA, NEC, ASME, NFPA, etc) and adherence to site quality assurance standards and specifications
- Difficulty of projects and ability to work autonomously increase with progression from Project Engineer I-III.
QUALIFICATION:
- Required
- Bachelor’s degree in Engineering or related field of study.
- Strong field management experience
- Previous Project Engineering experience
- Must be able to lift up to 20 pounds on a regular basis.
- Preferred Additional
- Background in or working knowledge of the Pharmaceutical industry
and cGMP’s preferable
- Chemical Manufacturing or Packaging Engineering experience is preferred
- Up-to-date Professional Engineer license
CRITICAL SKILLS AND ABILITIES:
- Strong working knowledge of design software, including AutoCAD, SOLIDWORKS, and CAD/CAM Circuit Design
- Proven understanding of compliance and quality assurance guidelines and best practices
- Ability to operate the following office equipment: computer, telephone, photocopier, facsimile, and calculator
- PowerPoint, Word, Excel, and a basic understanding of Microsoft media applications is required.
- Technical skills appropriate for the execution of technical transfers of topical products
- Data analysis with a good understanding of statistical process control
- PAT experience is preferred
- Bachelor’s degree in Engineering or related field.
PHYSICAL DEMANDS
- Must be able to lift and maneuver 40 pounds.
- Must be capable of standing for extended periods of time.
- Must be able to wear personal protection equipment, which includes gloves and a respirator, when required.
⚠️ Recruitment Disclaimer
We kindly request that third-party recruiters and agencies do not contact us regarding any job postings. All hiring is managed internally, and unsolicited outreach or candidate submissions will not be considered.
Skills Required
- Bachelor's degree in Engineering or a related field
- Strong field management experience
- Previous project engineering experience
- Ability to lift up to 20 pounds regularly
- Ability to lift and maneuver 40 pounds
- Ability to stand for extended periods
- Ability to wear required personal protective equipment, including gloves and a respirator
- Working knowledge of AutoCAD, SOLIDWORKS, and CAD/CAM Circuit Design
- PowerPoint, Word, Excel, and basic Microsoft media applications proficiency
- Understanding of compliance and quality assurance guidelines and best practices
- Technical skills for executing technical transfers of topical products
- Data analysis and understanding of statistical process control
- Pharmaceutical industry and cGMP knowledge
- Chemical manufacturing or packaging engineering experience
- Current Professional Engineer license
- PAT experience
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The Company
What We Do
Formulated Solutions is a U.S.-based contract development and manufacturing organization (CDMO) serving pharmaceutical, consumer-health and medical-device markets. It develops and manufactures non-sterile prescription, over-the-counter, medical-device and consumer-health products, including topical, nasal, aerosol, liquid and semisolid formats. Its integrated services span formulation and analytical development, technology transfer, regulatory support, scale-up, cGMP manufacturing and packaging, supporting products from early development through commercial production.
