Senior Project Engineer

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Job description

Senior Project Engineer (Pharmaceutical)

Portsmouth, NH area

Summary:

DPS Engineering is looking for a proven Senior Project Engineer to work with a BioPharma client in the Portsmouth, NH area. This individual will be responsible for leading the equipment selection, procurement, installation and start-up for an aseptic manufacturing line in compliance with all external legal and state requirements as well as internal systems and controls.

Responsibilities:

• Working with a selected A/E firm, lead the manufacturing equipment portion of the design, procurement, installation and start-up of an aseptic filling line.
• Ensure that the manufacturing equipment (including parts washer, isolator, clean utilities equipment, component sterilizer, product sterilizer and vial filling line) meets all commissioning, qualification, and validation requirements.
• Manage contractors and equipment vendors to ensure all aspects of the project are completed to specification, on schedule and according to budget.
• Manage changes to project scope ensuring original objectives are met in the appropriate timing.
• Identify and control project risks using appropriate risk management tools and engagement in contingency planning.
• Develop, manage and maintain up-to-date MS Project Timelines inclusive of all critical milestones, key interdependencies and resource constraints, applying appropriate project scheduling techniques.
• Prepare project estimates for design, equipment, installation, labor, materials, and other related costs.
• Partner with Purchasing to prepare bid packages for equipment; effectively lead the negotiation, award and management of contracts and purchase orders.
• Manage and oversee project contract work. Inspect or direct the inspection of work to ensure conformance to design drawings, specifications, schedules, and safety regulations. Ensure contractors receive site orientation and training and that all state/local code requirements, building permits, inspection and project close-out processes are followed.
• Provide project management reports and presentations. Regularly communicate project status, including challenges and opportunities.

Qualifications and Education:

• Bachelor's degree in Chemical, Mechanical or other related Engineering or relevant field.
• Minimum of 5+ years of project engineering experience in a Biopharmaceutical or Pharmaceutical manufacturing facility.
• Strong knowledge of biotech processing of aseptic manufacturing equipment.
• Must have previous experience managing capital projects in excess of $1 million dollars.
• Expert knowledge of Project Management methodologies and life cycle including ISPE good practice is required.
• Strong understanding of industrial and cGMP requirements, Engineering Life Cycle and associated quality systems.
• Experience facilitating meetings and establishing safe practices in a cGMP environment.
• Solid engineering capabilities related to reviewing and approving construction designs, equipment installation and specifications.
• Knowledge of electrical, mechanical and environmental engineering, HVAC systems, and utilities.
• Knowledge of commissioning, qualification and validation and other regulatory compliance requirements.