Project Engineer III

Project Engineer III

The Project Engineer III reports directly to the Vice President of Engineering and is directly responsible for the management and execution of Engineering related activities carried out within their assigned area(s) of responsibility (automation, capital projects, utilities, equipment, etc.). This includes the management of internal company resources, (assets, financial and personnel), external professional Engineering and other firms as part of the execution of equipment, facility or utility modification/upgrade, or expansion projects.

This direct management responsibility includes all support activities and functions necessary to ensure successful completion of project and/or Engineering objectives.

The position is responsible for development and management of process and facilities related projects; applicant must be familiar with the principles of capital project management including project scoping, capital estimation, business case analysis, project implementation, project commissioning, and project turnover/closure. The applicant must also be familiar with each aseptic product filling equipment used on the Denver site.

Essential Functions:

• Manage site activities necessary for successful execution of project(s) and ensure these are completed as necessary to tie in with the overall project execution.
• Ensure all company and site Engineering policies and procedures are adhered to.
• Ensure all work carried out and equipment installed is safe, effective and compliant with industry standards.
• Ensure all work undertaken is reflected accurately in up-to-date Engineering, project and Maintenance files.
• Report project status to the VP, Engineering, project team members, project management personnel, and functional stakeholders.
• Serve as liaison between professional Engineering firm(s), maintenance team members, construction firms, service firms, and site project team members involved in the project(s) at hand.
• Manage and resolve technical issues or changes arising throughout production equipment life cycle while also ensuring the overall production schedule, equipment performance, and budgeted cost to maintain are adhered to.
• Ensure all new or modified equipment, facilities, and utilities are handed over effectively to end users.
• Apply engineering expertise toward the development and continuous improvement of departmental toolsets, such as operational procedures, design specifications, and whitepapers.
• Perform any other activities as directed by the VP, Engineering. Leads consistently in productivity, quality and teamwork metrics.
• Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, EHS, etc.)
• Provide training and development oversight to support the growth of new or junior engineers.
• Other duties as assigned.

Supervisory Responsibilities:

• Supervision of Facility and Engineering team members may be required.

Experience and Necessary

Skills:

• Bachelor's degree required; technical degree preferred.
• 5 years minimum experience in managing facilities for a cGMP FDA regulated pharmaceutical manufacturing environment; 2 or more years aseptic processing facility preferred.
• Knowledge of cGMP guidelines/standards.
• Advanced problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred.
• Project Management experience required
• Experience in managing capital projects with a focus on aseptic focused filling equipment preferred.
• Strong results orientation.
• Excellent matrix management skills and organizational skills.
• Proficient in Microsoft Office products including Project, Outlook, Excel, and Word
• Proficient written, verbal and oral English communication skills are required.

Physical Requirements:

• Ability to stand or sit for extended periods of time.
• Ability to lift, push and pull up to 50 pounds periodically.
• Ability to maintain a gowning qualification, if applicable.
• Ability to work majorly on-site.

Benefits:

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance
• Employer Paid…