Job Description

Job Title
Project Engineer
Requisition JR000012892 Project Engineer (Open)
Location Hobart, NY (Pharma) - USA036
Additional Locations Hobart, NY
Summary of Position
Works as a key technical resource in supporting company objectives with respect to engineering design and project management in the implementation of capital projects and non-capital process improvements. Responsibilities include working with and/or leading the team to help identify, develop and execute projects to meet or exceed all company goals with respect to quality, schedule and spending. This could include: developing design concepts with the users; providing detailed design documents for some projects (e.g. P&IDs, construction drawings) ; equipment and instrument specification and installation; engineering calculations, developing request for proposals to bid projects; coordination with customers, contractors and consultants; reviewing documents, preparing capital appropriation requests, creating purchase orders, reviewing and paying invoices;; monitoring progress; assisting with training; executing commissioning activities; and ensuring proper project closure. Projects include but are not limited to: manufacturing systems, packaging systems, process piping, utility systems, facilities new construction and upgrades, and all other categories of capital spending. Provides technical leadership of equipment, automation and / or facility improvement projects within an operating commercial manufacturing facility with a primarily focus on technical deliverables around feasibility/ conceptual development, basic design, detailed design, implementation , commissioning and qualification. Job Results & Essential Functions Comprehensive Project Plans that Meet Business Needs
Leads external engineering and design teams, as well as internal resources, to develop capital project proposals to address complex manufacturing issues. Determines project specifications by studying product design, customer requirements, and performance standards; completing technical studies; preparing cost estimates. Provides design documents for appropriate capital or improvement projects including P&ID drawings, process piping sizing, instrumentation, flow calculations, electrical/mechanical/pneumatic drawings, etc. Leads efforts within Engineering, Process Development, Operations, Quality and Validation departments through the use of Good Engineering Practices to develop requirements and recommendations for new manufacturing systems and modifications to existing systems. Determines project schedule by studying project plan and specifications; calculating time requirements; sequencing project elements. Develops project schedules for product development projects and manages the projects meeting schedule requirements. Ready Solutions to Predicted Project Risks
Closely monitors the status and results of all activities carried out under the project plan(s). Projects spending and project scope changes and takes corrective actions to ensure that required deliverables are realized within approved spending limits. Identifies project roadblocks early in the process, and brings any areas of conflict with respect to resource allocation (budgets, manpower) to resolution. Insures resolution of cross-functional issues within the project team. When no resolution can be reached, ensures that issues are promoted. Uses knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale up projects.
Project Team Members Deliver Project Plan Milestones
Determines projects responsibilities by identifying project phases and elements; assigning personnel to phases and elements; reviewing bids from contractors. Manages team performance by establishing clear goals and expectations, tracking progress against the goals, ensuring timely feedback, and addressing performance problems and issues promptly through direct interaction and with the assigned employees\xe2\x80\x99 manager. Provides work direction for contractors/maintenance crews during project implementation. Continually evaluates priorities to ensures resources are deployed appropriately according to project priority.
Existing, New & Upgraded Equipment Meets Expected Production Rates
Supports maintenance and production activities including specification of components, component changes, and process modifications. Provides technical leadership in support of productivity improvement and cost reduction projects. Ensures continuous improvement of project management processes through evaluation, recommendation and implementation of improvements. Reviews all mechanical design changes made on assigned asset responsibility for operation, reliability, efficiency and safety. Facilitates focus groups as necessary to improve productivity and profitability. Implements recommended changes in a timely and cost-effective manner. Supports new equipment start up training initiatives as required. Works closely with maintenance and production to assure appropriate resources are trained on process and control systems. Complex Engineering Technical Guidance & Advice
Serves as the primary resource for resolving mechanical issues involving mechanical operation and safety. Provides engineering support to corrective actions and deviations by identifying root cause and offering solutions. Resolves high-level technical processing issues related to equipment operation. Position is, at times, hands-on requiring trouble shooting of complex automated equipment and processes. Acts as a subject matter expert for equipment operation and equipment efficiencies. Project Sponsor Is Aware of Project Variances in Real Time
Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions. Acts as the point of contact to communicate timely project status and budgets to all team members, project sponsor, SLT, and external customers. Facilitates project update meetings, ensures decisions and action items are documented and communicated to those who need to know. Key Competencies
Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.
Business case development: Uses financial analysis to evaluate and create strategic choices and options; knowledgeable about how the business and organization work; knowledgeable in current and possible future policies, practices, trends, and information affecting the business and organization; understands the competition; is aware of how tactics work in the marketplace; devises an approach that best positions an idea, plan or activity; leverages supportive factors, breaks through barriers, and addresses the unique needs and preferences of key decision makers.
Negotiation (balancing budget against trade-offs): Identifies and proposes solutions that benefit all parties involved in a situation; seeks out and builds relationships with others who can provide information, intelligence, career support, potential business, and other forms of help; accurately anticipates the implications of events or decisions for various stakeholders in the organization and plans strategy accordingly; can negotiate skillfully in touchy situations with both internal and external groups
Drives Execution: Coaches, mentors, and motivates project team members and influences them to take positive action and accountability for their assigned work. Demonstrates effective skill in planning, supervising, monitoring, and accomplishing projects. Knows how to organize people, activities, and processes to get things done efficiently and effectively. Exhibits passion for driving process and projects, and for achieving success through continuous innovation and execution to plan.
Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn\xe2\x80\x99t stop at the first answers.
Project Management: Knows how to organize people and activities; can see opportunities for synergy and integration where others can\xe2\x80\x99t; coordinates the diverse components of projects by quality project planning, execution and change control to achieve the required balance of time, cost and quality; manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives.
Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars. Incorporates Mallinckrodt Core Values in daily routine:

• Patient-Centric: Our decisions and actions are guided by our commitment to improve lives.
• Collaborative: We are inclusive and work together towards our common goals.
• Innovative: We are agile, always seeking new ways to continuously improve our performance.

Integrity: We do what we say we are going to do. Minimum Requirements
Education:
BS degree in an engineering discipline, preferable mechanical or pharmaceutical, or equivalent combination of education and experience. Experience:
Prefer 1-3 years experience, but would consider less with high potential candidate. Demonstrated ability to troubleshoot pharmaceutical operating equipment and support equipment. Pharmaceutical Formulation experience and or scale-up experience with solid and liquid dosage formulations. Preferred Skills/Qualifications:

• Strong written and verbal communication to include technical communication skills, both written and verbal, to accurately convey technical issues and information.
• Mechanical design abilities in manufacturing environment with a working knowledge of motors, controllers, plc\xe2\x80\x99s, feedback components and an ability to read and produce mechanical drawings.
• Understanding of solid and liquid pharmaceutical formulations and hands on experience in the manufacture of pharmaceutical products.

Other Skills/Competencies:

• Strong background in technical troubleshooting, problem solving.
• Detailed knowledge of equipment operation and validation requirements.
• Proficient knowledge of pharmaceutical cGMP requirements and systems.
• Ability to specify, procure, oversee installation, and commission systems and processing equipment.
• Knowledge of regulatory requirements for manufacturing of pharmaceutical products.
• This position requires the ability to think in high level terms to develop engineering solutions for new processes. It also requires the ability to think in specific, detailed terms when problem solving for existing processes.
• Intermediate Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts.
• Intermediate Microsoft Project skills as evidenced by the ability to assign resources and their work schedules to tasks, effectively use the different views, reports, and drawing tools, resolve time and resource conflicts, sort and filter information effectively and work with subtasks in an outline form, link tasks effectively and work with time constraints, create a baseline plan and track an active project

Physical Demands/Work Environment
Physical/Visual Activities or Demands: Physical/visual activities or demands that are commonly associated with the performance of the functions of this job:

• Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
• Must be able to work on a computer for extended periods of time.
• Must wear safety glasses and other protective items as required.
• Sitting 75% of the day; standing or walking 25%.

Job Type: Full-time