Project Manager - PMO

SHARP STERILE MANUFACTURING LLC•Lee, MA

14h

About The Position

The Project Manager facilitates all non-client site projects, ensuring they are completed on time, within budget, and meet quality standards while coordinating with cross-functional teams. This includes managing all lifecycle documentation such as SOPs, Change controls, CAPAs, and deviations for the individual projects.

Requirements

Three (3) to five (5) years of experience in project management within the capital project and continuous improvement projects sector
Strong understanding of pharmaceutical manufacturing processes and project management methodologies
Bachelor’s degree in Engineering, Business Administration, or a related field is typically required
Excellent communication, interpersonal and leadership skills
Strong problem-solving and analytical abilities
Organizational skills
Familiarity with project management tools and techniques, such as Gantt charts and risk management
Solid understanding of cGMP and regulatory requirements (FDA, EU, etc.)
Comfortable working in a dynamic, fast-paced environment.
Ability to sit for prolonged periods of time
Ability to lift up to 10lbs
Ability to stand for prolonged periods of time

Nice To Haves

Master’s degree or certification in Project Management is preferred
Experience with QMS tools such as MasterControl is preferred
Proficiency in Microsoft Office Suite

Responsibilities

Oversee the planning, implementation, and tracking of projects from initiation to completion, ensuring they align with company goals and customer expectations
Manage capital projects including cost, schedule and budget for projects. This encompasses monthly forecasting and planning project priorities to stay within the allocated funding for the year.
Manage project resources, schedules, and budgets, ensuring that projects are delivered on time and within scope
Identify potential project risks, assess their impact, and develop mitigation strategies to minimize disruptions
Develop and maintain comprehensive project documentation, including change controls, Design Specifications, User Requirement Specifications, project plans, progress reports, and final evaluations, to ensure transparency and effective communication among stakeholders
Negotiate with suppliers and contractors for resources and materials, ensuring quality standards are met and costs are controlled
Perform investigations and implement corrective actions related to CAPAs and deviations
Implement lean manufacturing principles to optimize processes for efficiency improvements and cost reduction
Manage the Project Management Office (PMO) list of projects including resource planning, project priorities and project hopper/funnel for next up projects.
Communicate PMO dashboard metrics on a monthly basis with senior leadership.
Communicate with clients and across departments to provide an understanding of validation activities
Perform factory and site acceptance testing of equipment, including the development of protocols, execution and report writing
Develop competencies in core process technologies and maintain knowledge of equipment and manufacturing technology changes
Provide technical assessments on change controls, deviations and investigations
Support process development activities
Other duties as assigned
Maintain working knowledge of 21 CFR 210/211, 21 CFR 820, EU Annex 1, and related regulations
Ensure all work is performed in accordance with current regulatory requirements and internal SOPs
Support data integrity initiatives and provide input to compliance metrics
Collaborate with various departments, including engineering, production, quality assurance, and supply chain, to ensure project requirements are met and to resolve any technical challenges
Coordinate staffing to support manufacturing schedules and priority projects