Job Title: Project Engineer
Department: Operations
Reports To: VP of Operations
FLSA Status: Exempt
Purpose:
Project Engineer or Project Management Engineer oversees planning and coordinating technical engineering initiatives to make sure we can complete a project within their budget and according to a schedule. Duties include upholding project standards by researching compliance regulations, developing project implementation plans and adjusting specifications for elements of a project.
Responsibilities
Review all the plans, status reports before the management meeting.
Conduct regular meetings with clients to ensure clarification and meet specific requirements in a timely manner.
Delegate tasks to team member according to their individual skill sets, experience, and abilities to ensure efficient completion of the project.
Maintain Budgets and adjust according to needs as they arise.
Track performance and analyze the completion of key goals.
Document and report project progress to stakeholders and clients.
Preparing cost estimates for materials, equipment, and labor.
Contract validation with client & contractor.
Supporting Supply chain for new Project Planner for Planning & Scheduling
Preparing Shop Drawing, As-built Drawing
Presenting Daily, Weekly, and Monthly reports to Management.
Review project deliverables and take corrective actions if any
Make sure the compliance to applicable codes, QA/QC policies, Osha standards, and specifications.
Supporting Design Engineers for any Technical issue
Reviewing any bid for new projects
Preparing Operational Manuals for new projects
Preparing Short-term schedule and handover for new installation with operations team
Will work with a Sr. Engineer to help execute process performance qualifications, and process simulation media fill protocols
Will execute trial batches, scale up batches and validation batch protocols to support process development
Will review deviations and change controls, perform process monitoring, and perform activities for lot release
Will help identify and provide solutions for process improvement pertaining to sterile injectable manufacturing. Perform risk assessment and mitigation steps to achieve validation requirements.
Skills and Qualifications
For a Project Engineer to be successful in their role they should possess the following skills and qualifications:
Organization and problem-solving skills
Ability to use specialized software for collaboration and time management, including spreadsheets (excel, Acad, MS Project, MS office, etc.)
Experience with inventory control and process improvement
Strong time management and analytical skills
Firm understanding of complex mathematical concepts
Proven leadership skills[i]
Strong communication skills
BS or MS degree in Engineering and/or Science.
Liquid processing knowledge (pressure, mass, volume, mixing tanks, CIP, etc.)
Min 2 yr. of experience as a Process Engineering experience preferred.
Working Conditions:
Must be able to stand/walk for up to 10 hours, and be able to frequently push, pull, squat, bend, and reach
Must be able to use hands and fingers to control equipment for forms of communication by grasping, reaching, and using finger dexterity
Utilize visual acuity to operate equipment, read technical information, and/or use a keyboard
Must be able, with or without reasonable accommodation, be able to lift up to 50 pounds depending on job task
Must be able, with or without reasonable accommodation, be able to operate carts, dollies, and hand trucks of up to 100 lbs.
Must be able to climb and descend stairs safely, with or without reasonable accommodation, and work on a secure mezzanine or ladder at a height of up to 25 feet
Must be able to work in cool conditions in the winter and warm conditions in the summer
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