Sr. Project Manager, Manufacturing

3390 Baxalta U.S.•Round Lake, IL

13h•Onsite

About The Position

Senior Project Manager is responsible for planning, executing, and delivering assigned site and inter‑site related projects, including but not limited to process improvements, equipment installations, and facility upgrades or expansions. The role ensures projects are completed on time, within approved scope and budget, and in compliance with quality, safety, and regulatory requirements. This role collaborates with cross‑functional teams to ensure alignment of project objectives and facilitate successful outcomes, contributing input to project prioritization and portfolio discussions to advance site objectives.

Requirements

Bachelor’s degree in Engineering, Science or related scientific field.
4+ years of relevant project experience in a manufacturing / engineering environment.
Experience and demonstrated ability to deliver successfully projects in various complexity, including capital projects, in a GXP manufacturing environment, within budget and on time.
Working knowledge of Project Management methodologies (e.g. Waterfall, Agile, Scrum, Lean/Six Sigma).
Experience and application of Organizational Change Management to project management.
Strong stakeholder communication skills and ability to lead cross-functional teams.
Proficiency with common project management software (e.g., MS Project, Excel, Asana, JIRA, or similar).
Excellent English verbal and written communication skills

Nice To Haves

Project Management Professional Certification or similar
Lean/Six Sigma experience
A Master’s degree in Engineering or related scientific discipline.
Background managing projects in GxP manufacturing environments (e.g., pharmaceuticals, medical devices, food & beverage) is highly preferred.
Experience with capital expenditure (CapEx) projects, including managing budgets, timelines, and resource allocations is ideal.
Strong experience with and understanding of global regulatory expectations and the evolving regulatory landscape, including key agencies, such as FDA and EMA.

Responsibilities

Lead cross-functional teams in the planning, execution, and delivery of assigned projects such as process optimizations, facility upgrades, capital expenditures, equipment installations, and other site initiatives.
Ensure projects are delivered on time, within scope, on budget, and to the required quality and safety standards.
Collaborate with key stakeholders to define the project scope, objectives, and deliverables.
Develop and maintain comprehensive project plans and schedules using standard project methodology tools (e.g., MS Project, Primavera, Jira).
Track project milestones and manage any changes to the project scope, schedule, and costs.
Serve as the primary point of contact for all project-related communications related to assigned projects.
Facilitate regular project meetings to review progress, address issues, and drive decisions.
Provide clear status reports to stakeholders and leadership and stakeholders (e.g. progress, risks, mitigation actions, and key decisions).
Foresee and identify potential project risks early and develop mitigation plans to address them.
Monitor risks throughout the project lifecycle and adjust plans as needed.
Resolve issues proactively that may arise during the project and escalate to the sponsor or senior management when necessary; engage Steering Committee members, as needed.
Ensure that all projects and related tasks align and comply with Takeda’s global and local site health and safety regulations, quality standards, regulatory requirements (e.g., cGMP, OSHA, ISO as applicable), local and global SOPs and standards.
Lead efforts to ensure that health, safety, and environmental risks are managed and that the project aligns with safety standards throughout its lifecycle.
For projects requiring adherence to Quality System standards, such as Change Control, Documentation Control, initiate, own, lead, and manage Quality System records to ensure completion of relevant workflow tasks and on time.
Maintain all project documentation requirements as per Project Management Lifecycle, including but not limited to agenda, meeting minutes, action logs, risk registers, spend reports, and more to be audit ready and future reference.
Work with relevant departments to ensure projects adhere to all internal Quality Assurance (QA) and regulatory compliance guidelines.
Coordinate resources required for assigned projects, ensuring team members and equipment are available and effectively utilized.
Lead and mentor project teams by providing support, tools, guidance, and remove obstacles, and guidance to achieve project goals.
Manage external vendors, contractors, and suppliers to ensure timely delivery of goods and services needed for project success.
Identify and implement continuous improvement initiatives through project management practices and process optimization.
Support adoption of Project Management methodologies (i.e. Agile), application of Lean Six Sigma principles, and other best practices, as applicable.
Maintain accurate project management documentation and publish as required by the local and global procedures and driven by standard industry practices in Project Management.
Monitor timelines, milestones, and performance metrics – report as required.