Aseptic Fill Finish Capital Project Manager

The Senior Project Manager will lead and oversee large-scale, complex capital projects, from conceptual design and budget estimate to equipment fabrication, construction, commissioning, start-up, and close-out. The Senior Project Manager is also responsible for developing a multi-objective project scope, establishing project controls, and developing project schedules. The Senior Project Manager will manage multiple stakeholders and be accountable for exploring alternative technology to offer to the internal customer.

General Responsibilities

Support A&E designs and develop project scope, preliminary budgets, and schedules for assigned projects.

Foster strong relationships with internal and external stakeholders, effectively addressing concerns and expectations throughout the project.

Facilitate meetings, presentations, and reporting to ensure stakeholders are informed of project status and changes.

Develop Request for Proposal documents for design services, construction services, and major equipment as needed.

Develop capital and Expense budget requests for future projects during the annual budget cycle.

Arranges for training of involved maintenance and operating personnel and obtaining and properly distributing all appropriate testing, certifications, validation, as-built, spare parts, operating or maintenance manual documentation, and drawings

Manage and coordinate (with site customers and subject matter experts) the efforts of construction management and general or trade sub-contractors to ensure the successful (i.e., safe, timely, high quality, cost-effective, legal) implementation of assigned projects.

Administer, resolve, and control all design, construction, contractual, and financial issues on assigned projects.

Implement best practices and continuous improvement initiatives within project methodologies.

Ensure frequent communication and regularly schedule meetings between the Project Team, project sponsor, and stakeholders.

Select, manage, and coordinate the efforts of design consultants and firms as appropriate.

Ensure all applicable local, state, and federal regulatory requirements are met on assigned projects.

Documentation and Risk Management

Provide or arrange the development of complete design documentation for assigned projects.

Prepares documentation necessary for project approvals.

Generates change control documentation as required by project commissioning needs.

Provides qualification documentation for assigned projects as applicable.

Identify potential project risks and develop mitigation strategies to minimize impacts.

Regularly assess project progress and adjust plans as necessary to address challenges.

QUALIFICATIONS, DESIRED EDUCATION, AND EXPERIENCE

A Bachelor of Science in Engineering (BSE) is required, and a Master's level degree (Mechanical, Electrical, or Chemical Engineering) is preferred, with a minimum of 10 years of experience designing, developing, and commissioning high-complexity new manufacturing processes in an FDA-regulated environment ranging from $10 - $100MM

PMP Certification or PE License preferred.

A minimum of 5 years of engineering experience in aseptic filling and lyophilization operations is required.

Strong interpersonal, teamwork, and problem-solving skills. Motivated self-starter with excellent verbal and written communication skills.

Demonstrated leadership, management, and technical capabilities.

Demonstrated commitment to values-based leadership and achieving objectives

Demonstrated ability to interact with all levels of the organization.

Strong skills in various project management systems, including PowerPoint, MS Project, MSPO, etc.

Demonstrated ability to present and outline key project deliverables and scope to the senior leadership team for approvals to initiate the project and intermediate updates throughout the project.

The Senior Project Manager will lead and oversee large-scale, complex capital projects, from conceptual design and budget estimate to equipment fabrication, construction, commissioning, start-up, and close-out. The Senior Project Manager is also responsible for developing a multi-objective project scope, establishing project controls, and developing project schedules. The Senior Project Manager will manage multiple stakeholders and be accountable for exploring alternative technology to offer to the internal customer.

General Responsibilities

Support A&E designs and develop project scope, preliminary budgets, and schedules for assigned projects.

Foster strong relationships with internal and external stakeholders, effectively addressing concerns and expectations throughout the project.

Facilitate meetings, presentations, and reporting to ensure stakeholders are informed of project status and changes.

Develop Request for Proposal documents for design services, construction services, and major equipment as needed.

Develop capital and Expense budget requests for future projects during the annual budget cycle.

Arranges for training of involved maintenance and operating personnel and obtaining and properly distributing all appropriate testing, certifications, validation, as-built, spare parts, operating or maintenance manual documentation, and drawings

Manage and coordinate (with site customers and subject matter experts) the efforts of construction management and general or trade sub-contractors to ensure the successful (i.e., safe, timely, high quality, cost-effective, legal) implementation of assigned projects.

Administer, resolve, and control all design, construction, contractual, and financial issues on assigned projects.

Implement best practices and continuous improvement initiatives within project methodologies.

Ensure frequent communication and regularly schedule meetings between the Project Team, project sponsor, and stakeholders.

Select, manage, and coordinate the efforts of design consultants and firms as appropriate.

Ensure all applicable local, state, and federal regulatory requirements are met on assigned projects.

Documentation and Risk Management

Provide or arrange the development of complete design documentation for assigned projects.

Prepares documentation necessary for project approvals.

Generates change control documentation as required by project commissioning needs.

Provides qualification documentation for assigned projects as applicable.

Identify potential project risks and develop mitigation strategies to minimize impacts.

Regularly assess project progress and adjust plans as necessary to address challenges.

QUALIFICATIONS, DESIRED EDUCATION, AND EXPERIENCE

A Bachelor of Science in Engineering (BSE) is required, and a Master's level degree (Mechanical, Electrical, or Chemical Engineering) is preferred, with a minimum of 10 years of experience designing, developing, and commissioning high-complexity new manufacturing processes in an FDA-regulated environment ranging from $10 - $100MM

PMP Certification or PE License preferred.

A minimum of 5 years of engineering experience in aseptic filling and lyophilization operations is required.

Strong interpersonal, teamwork, and problem-solving skills. Motivated self-starter with excellent verbal and written communication skills.

Demonstrated leadership, management, and technical capabilities.

Demonstrated commitment to values-based leadership and achieving objectives

Demonstrated ability to interact with all levels of the organization.

Strong skills in various project management systems, including PowerPoint, MS Project, MSPO, etc.

Demonstrated ability to present and outline key project deliverables and scope to the senior leadership team for approvals to initiate the project and intermediate updates throughout the project.