Associate Director, MMR Capital Projects Lead

Job Description

The Capital Projects Technical Lead is responsible for providing project, engineering, and operations support to a bulk manufacturing vaccine facility as well as the Organization at our Company’s West Point, PA site. Responsible for process, equipment, and facility projects of varying complexity and size, implementing continuous improvement projects, supporting equipment and investigations as required. Work as an individual contributor, team or project lead.

Accountability:

• Ensure that Area objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices, equal employment opportunity, finances, labor, employee, environment and safety.

• Tactical and strategic project management, including collaboration with indirect staff.

• Manages large or multiple small projects with moderate resource requirements, risk and/or complexity.  Develops capital plan for End to End and manages portfolio

• Forecasts, plans and monitors costs and headcount requirements for moderately sized projects and/or service level agreements for country/divisional vendors;

Duties:

• Collaborate closely with the IPT and E2E leaders to implement the organization's strategic initiatives, ensuring alignment with the company's overall objectives and the overall our Manufacturing Division strategy.

• Oversees and is accountable for the management, oversight, and successfully delivery of select IPT programs and key initiatives.

• Responsible for process, equipment, and facility projects of varying complexity and size, implementing continuous improvement projects, supporting equipment and investigations as required.

• Supports, executes, and/or leads process, equipment, and facility projects for a vaccine manufacturing organization.

• Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/standardize and/or gain efficiencies.

• Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.

• Designs, conducts, and/or reviews and approves experimental protocols as needed.

• Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a GMP environment.

• Supports regulatory and internal audit inspection activities.

• Provides on-the-floor support of complex operational and technical (process/equipment/facility) issues.

• Completes and/or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.

• Supports team safety, environmental, and compliance objectives.

• Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.

• Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.

• Partners with other sites, divisions, and organizations to evaluate and execute innovative solutions within vaccine manufacturing.

Specific tasks/roles can include but are not limited to:

• Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement. Responsible to author, review and/or approve compliance documents, as per procedures or need.

• Work is primarily achieved by individual or through project teams, utilizing technical expertise to achieve results.

• Requires specialized depth of expertise in own discipline and limited knowledge of other disciplines.

• Interprets internal/ external business challenges and best practices to recommend improvements to products, processes or services.

• Solves complex problems; takes a br