Sr Project Engineer

at  Avara Pharmaceutical Technologies Inc

Purpose & Scope:
Manage small- to large-sized engineering, capital improvement, and facility expansion projects relating to supporting the site. Develop work practices and develop and train other members of the engineering team. Responsible for technical leadership in equipment improvement, troubleshooting, and improvement of equipment processes. Apply technical expertise to maintain and improve daily manufacturing operations maximizing APT’s ability to produce the highest-quality products in a cGMP environment.

Essential Job Responsibilities:

• Coordinate and manage various contractor trades, contract architectural, and engineering consultants to execute various projects in support of the APT facility
• Plan, lead, and execute small- to large-sized engineering projects, including capital projects from conceptual phases through project closeout including scope development, cost estimation system design, equipment sizing and selection, obtaining funding approval, controlling cost and schedule, procurement, installation, check-out, startup, and validation support.
• Execute concurrent assignments with emphasis on established business priorities.
• Provide support in the design, installation, start-up, and maintenance of a variety of mechanical systems to support day-to-day operations of a pharmaceutical manufacturing facility, which include but are not limited to general HVAC, USP water, systems, compressed dry air, dust collection, process cooling and heating water, steam systems, waste treatment, and various types of process and support equipment.
• Participate in the validation or required equipment and processes.
• Investigate equipment problems and design modifications to improve reliability, productivity, and safety. Investigations will involve failure analysis to determine the basic cause of equipment failures and recommendations for design improvements to reduce or eliminate failures.
• Identify, evaluate and implement facility improvement activities. Establish required operating costs/savings and energy calculations, and research to provide an accurate assessment for proposed improvements while maintaining cGMP compliance.
• Assure excellent and timely communication of projects. Provide technical leadership, expertise, and presentations to various stakeholders and senior management.
• Evaluate the maintenance of physical assets of the plant to ensure continued operation and attainment of line effectiveness, yields, and costs.
• Assess maintenance and equipment performance and develop predictive and proactive plans.
• Develop and use engineering methodologies, systems, and tools as defined by APT.

Quantitative Dimensions:

• Coordinates projects over APT departments with a strong client relationship with APT operations.
• Manages 8-12 capital projects each year.
• Works cross-functionally with all local departments.
• Manages and tracks all facility utilities and electrical energy usage (> $1 million annually).
• Manages facility fuel/gas contracts, forecasting and purchasing (> $1 million annually).
• Responsible for annual project budget in excess of $2 million, which range individually from$1k to $850k

Organizational Context:

• Reports to Director of Engineering.
• Manages numerous contractors / personnel in the coordination and execution of various projects.

Qualifications:

Required

• A minimum of 10 years’ engineering and project management experience, including 3 years in a pharmaceutical/cGMP environment.
• BS/MS degree in Engineering.
• Demonstrated experience managing multiple large-scale projects at a given time.
• Knowledgeable in federal, state and local regulations and codes. Apply this knowledge to develop specifications for mechanical, electrical and other utility systems.
• Demonstrated knowledge of project management techniques such as planning, scheduling, execution, and control of scope, costs, and time. Knowledge of maintenance skills and the general operation of equipment.
• Working knowledge of Word, Excel, MS Project, and Outlook.
• Minimum to no supervision required.
• Relies on solid experience, leadership, and judgment to plan and accomplish goals. A wide degree of creativity and latitude is expected.
• Excellent time management, research, presentation, decision-making, and problem-solving skills, as well as strong interpersonal written and communication skills.
• Must be able to work to meet deadlines. Must be able to gather and evaluate complex data to make effective decision to accomplish work.
• Working in a fast-paced office setting with a minimal lifting requirement of ten pounds.
• Must be able to read, write and understand the English language (statement common to all Job Descriptions).

Preferred

• Experience and working knowledge of PowerPoint, Visio, CADD and SolidWorks for on-going tracking / documentation of various projects.
• Knowledge of industry and company practices, and cGMP requirements in facilities and processing.

• Coordinate and manage various contractor trades, contract architectural, and engineering consultants to execute various projects in support of the APT facility
• Plan, lead, and execute small- to large-sized engineering projects, including capital projects from conceptual phases through project closeout including scope development, cost estimation system design, equipment sizing and selection, obtaining funding approval, controlling cost and schedule, procurement, installation, check-out, startup, and validation support.
• Execute concurrent assignments with emphasis on established business priorities.
• Provide support in the design, installation, start-up, and maintenance of a variety of mechanical systems to support day-to-day operations of a pharmaceutical manufacturing facility, which include but are not limited to general HVAC, USP water, systems, compressed dry air, dust collection, process cooling and heating water, steam systems, waste treatment, and various types of process and support equipment.
• Participate in the validation or required equipment and processes.
• Investigate equipment problems and design modifications to improve reliability, productivity, and safety. Investigations will involve failure analysis to determine the basic cause of equipment failures and recommendations for design improvements to reduce or eliminate failures.
• Identify, evaluate and implement facility improvement activities. Establish required operating costs/savings and energy calculations, and research to provide an accurate assessment for proposed improvements while maintaining cGMP compliance.
• Assure excellent and timely communication of projects. Provide technical leadership, expertise, and presentations to various stakeholders and senior management.
• Evaluate the maintenance of physical assets of the plant to ensure continued operation and attainment of line effectiveness, yields, and costs.
• Assess maintenance and equipment performance and develop predictive and proactive plans.
• Develop and use engineering methodologies, systems, and tools as defined by APT