BioSpace · 1 day ago

Project Engineer - GMP Facilities

Massachusetts, United States

Full-time

Remote

Entry, Mid Level

2+ years exp

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Comp. & Benefits

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Responsibilities

Provide overall management of facility activities through the entire life-cycle including scope management, scheduling, budgeting and coordinating activities interdepartmentally and with contractors.

Develop scopes, specifications, estimates, and standards for facility related projects.

Oversee all on-site contractors for assigned projects/tasks including site pest control provider and facility maintenance contractors. This includes (but is not limited to) scheduling of contractors around production operations, generation of contractor safety permits, oversight of contractor safety while on site, and continuous review / approval of contractor equipment installation during construction.

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.

Plans and conducts small- to medium-size assigned projects within engineering specialty requiring conventional types of plans, investigations, and/or equipment. Coordinates and monitors activities/projects. Reviews plans and monitors status of implementation for those assigned to project; makes judgments regarding quality of implementation within discipline; employs contingency plans to recover from schedule slippage and financial overruns when appropriate.

Estimates and coordinates resources needed (materials, budget, time and people) to accomplish assigned individual tasks. Anticipates future directions. Benchmarks internally and externally. Recognizes changes in the environment and present resources as indicators of future problems and opportunities; prepares for such eventualities.

Independently executes the design of products/processes/equipment/systems/facilities by applying standard engineering theories, concepts, and techniques within the discipline. Independently investigates, conducts tests or experiments.

Creates/modified designs for intermediate problems. Designs/modifies more complex components/processes; writes detailed design specifications. Predicts patterns/trends. Grasp complexities and sees relationships among data; determines consequences and alternatives; makes recommendations.

Implements good ideas/innovations/costs reductions; consistently generates/adopts original solutions to problems and reduces them to practices.

Mentors others by sharing technical expertise and providing feedback and guidance. Resolves underlying problems. 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.

Directs the efforts of others such as technicians and outside resources. Performs tasks such as writing Requests for Capital Expenditures (RCEs), safety/quality checklists, scope documents, etc. Develops and executes validation protocols.

Qualification

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GMP Facilities EngineeringISO 5-8 StandardsProject ManagementEngineering DegreeHealth Care Industry Knowledge

Required

A Bachelors Degree in Engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 2+ years of significant engineering and/or operational experience.

Has demonstrated competency within a discipline.

Possesses a working technical knowledge and application of concepts, practices, and procedures.

Ability to work on problems of moderate scope where analysis of situations or data requires a review of identifiable 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.