Sharp Sterile Manufacturing · 7 hours ago
Project Manager - PMO
Lee, MA, US
Full-time
Onsite
Mid Level
$70K/yr - $100K/yr
3+ years expSharp Sterile Manufacturing is focused on delivering high-quality manufacturing services, and they are seeking a Project Manager to facilitate non-client site projects. The role involves overseeing project planning, implementation, and tracking while managing resources, budgets, and ensuring compliance with regulatory standards.
BiopharmaBiotechnologyHealth CareLife Science
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
Qualification
Required
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
Proficiency in Microsoft Office Suite
Preferred
Master's degree or certification in Project Management
Experience with QMS tools such as MasterControl
Company
Sharp Sterile Manufacturing
Sharp Sterile (formerly Berkshire Sterile Manufacturing) provides the safest sterile drug products for clinical use and small scale requirements through the use of modern technology, 100% isolator-based filling lines, and a skilled staff.
201-500 employees
H1B Sponsorship
Sharp Sterile Manufacturing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (7)
2023 (6)
2022 (2)
2021 (2)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$2MKey Investors
MassDevelopment
2023-10-05Acquired
2018-07-17Debt Financing· $2M
Recent News
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