Project Engineer - GMP , Automation

Job Summary:

The Project Engineer provides day-to-day performance monitoring and feedback and is responsible for full management of scoping, design, bid analysis and construction contractors, along with fiscal management of each project and a group of projects to meet all financial and schedule targets. The Project Engineer creates and maintains various reports and documents to measure the status of each of his/her projects. The Project Engineer serves as the day-to-day manager of both small and high-profile projects that are often complex, fast-track projects and often occur while the buildings are occupied and operating. The Project Engineer partners with executives, managers, and staff to work on various aspects of planning, evaluating (cost/benefit), managing operational impacts of the project and evaluating ongoing operational aspects.

On-Site Expectations:

• 100% on-site position.

Responsibilities:

• Manages projects (capital, construction, utility, green initiatives, etc.). Oversees the project planning process, including developing a project implementation plan, collecting project requirements, defining the project scope, defining project activities, developing project activity sequencing, establishing activity resource needs, establishing activity durations, developing project schedules, developing cost estimates, developing communications and risk management plans. Determines project specifications, determines project phases and prepares cost estimates.

• Manages project from beginning to end:

• Identifies requirements, develops, and prepares written project scope of work and other concept phase documents.

• Develops information necessary for RFP process, manages formal bid process and selection of contractors.

• Selects and works with consultants/A&E firms and/or equipment vendors to create project drawings and specifications as applicable.

• Manages design review process and secures all applicable approvals.

• Provides value engineering expertise based on constructability, design expertise and calibrates design solutions.

• Reviews plans, specifications, and submittals for new and remodeled building projects for code compliance and building standards.

• Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones.

• Provides facilities and utilities support for new or modified equipment used to manufacture new active pharmaceutical ingredients.

• Provides enhanced troubleshooting and manufacturing support for filling operations on all 4 product lines.

• Provides input to the maintenance program (preventative maintenance programs, repairs, spare parts program, etc.).

• Provides assistance to the facilities maintenance team, which includes troubleshooting and guidance.

• Assist with utilities such as but not limited to HVAC, compressed air, WFI, Pure Steam, nitrogen, chilled water, etc.

• Provides support as required during facility shutdowns.

• Able to assist with freeze dry operations, as needed.

• Requests bids from contractors and suppliers by working with procurement group, recommends best provider.

• Formal CAPEX document preparation and submission.

• Controls project plan and maintains project schedule by closely monitoring project progress, coordinating activities on critical path.

• Controls project costs by approving expenditures; administers contracts and monthly expenditures against planned cash flow.

• Prepares project status reports.

• Responsible for commissioning and coordinating of equipment/areas in preparation for validation activities.

• Maintains company reputation by complying with applicable federal and state regulations. Demonstrates company loyalty in relations with company personnel.

• Maintains a safe, clean, and organized work environment free of safety hazards.

• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

• Other duties as assigned.

Qualifications:

• Bachelor's degree in engineering.

• Minimum 4 years' experience in engineering project planning/management.

• Pharma experience required.

• GMP and automation experience strongly preferred

Knowledge, Skills, and Abilities:

• Able to perform assigned tasks carefully and on schedule according to standard operating procedures and supervisor's instructions.

• Ability to work with people at all levels of the organization.

• Ability to perform complex math functions, compute ratios, rates, and percentages.

• Ability to draw and interpret graphs and charts.

• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.

• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

• Excellent verbal communications and presentation skills required.

• Proficiency with Microsoft Office applications.

Travel Expectations:

• Up to 5% domestic travel required.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an 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 frequently required to stand, walk; sit; talk or hear; use hands to finger, handle or feel. The employee is occasionally required climb or balance and stoop, kneel, crouch, or crawl; reach with arms and hands. The employee must regularly lift and/or move up to 25 pounds, and some of the time move up to 50 pounds. While performing the duties of this job, the employee frequently works near moving mechanical parts, occasionally is exposed to fumes or airborne particles, risks of electrical shock or vibrations.