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Sr. Project Engineer - Pharmaceutical Manufacturing

Company: Alcami Corporation
Location: Charleston
Posted on: March 18, 2023

Job Description:

Position Summary

The Senior Project Engineer is accountable for driving superior results in a fast-paced environment by being responsible for multiple large capital related projects. The Senior Project Engineer will be responsible for managing multiple assigned projects including construction, process improvements, equipment installation and other capital projects while performing all related activities to ensure such efforts adhere to schedule, meet budget and accomplish the defined scope. This role is responsible for implementing and designing projects (capital, construction, utility, green initiatives, process improvement efforts) which includes working with cross-functional departments to understand the scope and needs of the project and developing the project implementation plan within budget and schedule guidelines. This professional reviews design for quality compliance, safety and adherence to company standards as well as customer contract requirements. This position will ensure the project accomplishes objectives by planning and evaluating project activities. The Senior Project Engineer will execute design responsibilities for some projects.

The Senior 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 financial and schedule targets. The Senior Project Engineer creates and maintains various reports and documents to measure the status of each of his/her projects. The Senior 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 occurring while the buildings are occupied and operating. The Senior 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. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. Th Senior Project Engineer will be responsible for mentoring less tenured project engineering professionals, capable of providing guidance and mentorship in the execution of engineering projects and responsibilities.

Essential Functions

  • Manages multiple 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.
    • Often responsible for providing primary project design support for larger and more complex projects.
    • 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.
    • Requests bids from contractors and suppliers by working with procurement group; recommends best provider.
    • Completes 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. Education and Experience
      • Bachelor's Degree in Engineering.
      • Minimum 10 years' experience in engineering project planning/management.
      • Previous work experience in a sterile manufacturing environment preferred.
      • Automation and controls background preferred. Alcami Non-Negotiables
        • Consistently demonstrates honesty and integrity through personal example.
        • Follows all safety policies and leads by example a safety first culture.
        • Produces high quality work product with a focus on first time right.
        • Complies with the company code of conduct and policies and regulatory standards. Alcami Core Leadership Competencies
          • Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
          • Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
          • Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
          • Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
          • Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
          • Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with. Functional Competencies
            • 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. Decision Making and Supervision Required
              • Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
                • Receives minimal instruction on day-to-day work, general instructions on new assignments. Travel Requirements
                  • Up to 5% domestic travel required.
                    Physical Demands and Work Environment

                    The physical demands and work environment 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 regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.

                    Other Duties

                    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Keywords: Alcami Corporation, Charleston , Sr. Project Engineer - Pharmaceutical Manufacturing, Healthcare , Charleston, South Carolina

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