Project Engineer

Project Engineer

The Project Engineer is an engineering professional who, working with little or no supervision, applies project management knowledge, engineering knowledge and ingenuity to complete medium size projects from concept thru project closure, across disciplines and locations. Responsible for financial management, contractor management, and project oversight for equipment and facility projects. To be successful, the position will interface with Operations, Maintenance, Engineering, suppliers, and 3rd party contractor firms. Candidates should feel comfortable working in a plant environment. Strong communication and leadership skills along with technical knowledge of pharmaceutical/medical device projects are required.

Responsibilities:

• Responsible for supporting capital projects in the manufacturing plant, including front end planning activities.
• Coordinate multiple parties to complete project scopes on schedule, stay within budget and meet the expected quality.
• Assist with design of new equipment systems from preliminary design, specifications, budgeting, scheduling, and construction management.
• Develop project schedules including setting targets for milestone activities and adhering to deadlines.
• Track progress to ensure the project scope, cost, and schedule are being met Manage the life-cycle documentation of the equipment including generation and approval of user requirements, equipment and instrument specifications, equipment test plans, and system operating procedures.
• Develop documents for FAT, SAT, and qualification activities for equipment.
• Participate in FAT, SAT, startup, commissioning and qualification of equipment.
• Write scope of work documents, award contracts, obtain estimates, select suppliers, and purchase equipment and services.
• Review drawings, supervise contractors, and participate in final project acceptance upon completion of construction.
• Making effective decisions when presented with multiple options for how to progress with the project.
• Communicating with management to keep the project aligned with their goals.
• Performing quality control on the project throughout development to maintain the standards expected.

Requirements:

• Bachelor's Degree in Engineering, Science, or closely related discipline, or equivalent technical experience plus demonstrated competence.
• Technical background in Pharmaceutical or similar GMP-regulated industry.
• Expertise in equipment design, design specifications, and PFD/P&ID development.
• Experience with manufacturing equipment commissioning and qualification.
• Familiarity with PLC control systems.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
• Works well with other engineers in a collaborative, fast-paced goal-driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences.
• Understanding and management of procurement & contracting processes.
• Experience with automation and controls engineering.
• Experience with drug product and oral solid dosage manufacturing and equipment.

Core Responsibilities: Draft and execute:

• Verification & Qualification documentation.
• Factory Acceptance Tests (FAT).
• Software Acceptance Tests.
• Site Acceptance Tests (SAT).

Support:

• Equipment upgrades.
• Automation-related changes.

Perform:

• On-site equipment testing.
• Validation execution.

Work on:

• Automation & control system-heavy upgrades.

Most Important:

• CQV / Validation experience.
• Automation & HMI exposure.
• Strong communication skills.

Important:

• 4+ years experience.
• Bachelor's degree (mandatory).
• OSD / Pharma equipment experience.
• Capital project exposure.

Top 3–5 Skills / Experience:

• Chemical or Mechanical Engineering degree strongly preferred.
• Develop documents for FAT, SAT, and qualification activities for equipment.
• Participate in FAT, SAT, startup, commissioning and qualification of equipment.
• Experience with automation and controls engineering preferred.
• Experience with drug product and oral solid dosage manufacturing and equipment preferred.