Berkshire Sterile Manufacturing
Position Summary
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.
Duties and 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, 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 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. Other duties as assigned Regulatory Responsibilities
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 Supervisory Responsibilities
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 Experience
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 Education
Bachelor's degree in Engineering, Business Administration, or a related field is typically required Master's degree or certification in Project Management is preferred Knowledge, Skills & Abilities
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. Experience with QMS tools such as MasterControl is preferred Proficiency in Microsoft Office Suite Physical Requirements
Ability to sit for prolonged periods of time Ability to lift up to 10lbs Ability to stand for prolonged periods of time
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.
Duties and 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, 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 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. Other duties as assigned Regulatory Responsibilities
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 Supervisory Responsibilities
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 Experience
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 Education
Bachelor's degree in Engineering, Business Administration, or a related field is typically required Master's degree or certification in Project Management is preferred Knowledge, Skills & Abilities
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. Experience with QMS tools such as MasterControl is preferred Proficiency in Microsoft Office Suite Physical Requirements
Ability to sit for prolonged periods of time Ability to lift up to 10lbs Ability to stand for prolonged periods of time