Project Manager

Ultimate Solutions USA is seeking an experienced Project Manager (PM) to support project execution for commercial manufacturing lines. As a PM, you will serve as the central point of contact between internal stakeholders, external vendors, and OEMs to coordinate and manage all project deliverables. You will be responsible for overseeing project timelines, tracking progress, managing documentation, and ensuring alignment across all phases of the project lifecycle, including equipment delivery, installation, testing, and validation. The ideal candidate will have strong organizational and communication skills, experience working in regulated environments, and the ability to lead cross-functional teams toward successful project completion.

Key Responsibilities

Manage the full project lifecycle from initiation through closeout.

Oversee project governance and ensure adherence to site and regulatory standards.

Lead project scope management and change control processes.

Develop and manage detailed project schedules, timelines, and milestones.

Serve as the primary point of contact for project coordination and the first escalation channel for issues.

Ensure seamless internal communication to align project documentation with overall strategy.

Lead risk and issue management to mitigate delays or compliance gaps.

Coordinate with OEMs on equipment documentation through all project phases: Pre-FAT, FAT, SAT, and C&Q/Validation.

Assist in capacity forecasting and maintain project dashboards for tracking timelines and budgets.

Represent the project team in technical meetings and ensure alignment of deliverables.

Support the C&Q/Validation Lead in developing and executing materials and documentation required for successful validation activities.

Required Qualifications

Bachelors degree in Engineering, Life Sciences, or related field.

5+ years of project management experience, preferably in pharmaceutical or biotech environments.

Strong knowledge of GMP, validation processes, and capital equipment lifecycle.

Excellent coordination skills with OEMs, contractors, and internal stakeholders.

Proficient in MS Project, Smartsheet, and related tools.

Preferred Qualifications

Experience with FAT/SAT/C&Q protocols and documentation requirements.

PMP certification or equivalent is a plus.