Senior Capital Project Engineer- Onsite

Role Summary

Senior Capital Project Engineer- Onsite

Responsibilities

• Development of user requirements, biologics equipment P&ID‚Äôs (Piping and Instrumentation Diagrams), technical/functional specifications to support automation programming and processes.
• Conducts design review including specifications, procurement, fabrication management, and installation of equipment, facilities, and utilities related to the manufacture of biologics bulk drug substance including basic unit operations involving fermentation, cell culture and protein purification and related equipment.
• Performing engineering calculations required to size process lines, equipment, and instrumentation, procurement and fabrication management involves reviewing and approving piping, instruments, and equipment proposed by a vendor or field contractor based on the suitability of the proposed item to perform as designed, and completing installation design by providing the required utilities, space, piping, and environmental controls required to operate the area or equipment as designed;
• Oversee mechanical design of all vendor-fabricated equipment, including review and approval of all vendor submittals with internal stakeholders, and preparation/execution of factory and site acceptance testing (FAT / SAT) protocols
• Responsibilities of this engineering grade level inherently include and expand upon the responsibilities established for lower engineering grade levels.
• Responsible for compliance with applicable policies and procedures.
• Independently plans and conducts small- to medium-size assigned projects within engineering specialty requiring conventional types of plans, investigations, and/or equipment. Manages multiple, often concurrent, projects and meets deadlines. Responsible for achieving the project's financial targets in support of business objectives. Maintains project controls and reporting for cost, scope and schedule; develops execution strategy including procurement. Balances multiple demands.
• Produces unique and cost-effective results. Establishes alternate use possibilities and incorporates flexibility; balances system costs with benefits provided; oversees design work of internal and external consultants, Creates/modified designs for intermediate problems. Integrates financial with technical data. Analyzes complex interdisciplinary problems and identifies their impact; establishes probabilities; draws conclusions reflecting broad business needs.
• Represents engineering on corporate task forces. Identifies full range of customer/client needs and proposes solutions to address them; makes alterations in products or services to better meet (recognized or unrecognized) customer need. Monitors the improvement of other engineer and may participate in the evaluation of assigned staff/project team members and in the identification of development needs. May supervise other engineers or technicians.

Qualifications

• Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 5+ years of significant engineering and/or operational experience. A post-graduate education/degree is desired, and may contribute towards the desired years of experience.
• A background in biopharmaceutical manufacturing and/or biologics equipment operation/troubleshooting is required
• Has demonstrated competency within a discipline.
• Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Demonstrates judgment within defined procedures and practices to determine appropriate action.
• 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.
• Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
• Has demonstrated competency with financial systems and in fiscal control.

Education

• Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience.

Additional Requirements

• None beyond the standard job requirements listed above.