Danaher Corporation Project Manager, Single Use Remediation in Westborough, Massachusetts
Help us improve access to life-changing therapies that can transform human healthWe are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.We are looking for a Remediation Project Manager to lead our expert global cross-functional teams from Global Supply Chain, Engineering, Product Management and Quality Assurance responsible to establish a product library in Magic based on the product structure of the legacy product(s) produced at the Westborough Site You will be accountable for establishing Design History Files and Master Records. Lead a team to verify records for accuracy and completeness, identify gaps to support the desired product structure, and take the necessary actions to close them. Provide inputs on resource requirements, business risks, and equipment required to achieve project goals. Ensure clarity on scope and deliverables for the products you will be responsible for. Does this sound like your passion? Then we would love to hear from you.What you’ll doEstablishment of the product library, including management of the delivery scope, budget and timeline. Generate project plan to review existing documents, establish library to support the assigned products; based on gaps identified and make recommendations for staffing/support.Lead the team in identification of gaps in design documentation to support our legacy product to include but not limited to Design FMEA; Product FMEA; Design Verification; Design Validation; Component, Sub-assembly, Assembly and Equipment Drawings; Component Specifications; Bills of Materials; Packaging Requirements; Labelling Requirements; Acceptance and Incoming receiving Requirements; Manufacturing Procedures; Supplier Qualification; IQ/OQ/PQ of all equipment in manufacturing operation; Process MapsManages costs to maintain the Business expectations while coordinating with site and business functions for needed support and ensure early engagement with the cross-functional team on planning and scoping.Works in partnership with the Wing to Wing Supply Chain Team as well as other functions including Sales and Operational Planning, Material Leadership, Business Team Leaders, Facilities Leader, Planners, Buyers, Production Team Leaders, and Logistics and Distribution Specialists. Develops a communication plan that will ensure seamless communication with the Project Team, Project Steering Committee, and the indirect stake holders. Works with SMEs and Project Management Leaders on all Project Change Orders, deviations, Scope, specification and timeline changes. Works with Finance, Leadership, and Op Ex Team to manage budget changes. Monitors transportation, installation and IQ/OQ if needed.Has knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirementsWorks with Quality Assurance and Regulatory to ensure all requirements and regulations are met. Complies with Company Quality Management System, Policies, Goals, and applicable laws and regulations as they apply to this job type/position. Identifies and reports any quality or compliance concerns and take immediate corrective action as required.Who you areBachelor’s Degree in Engineering, or equivalent degree with 8 or more years of working experience in the following areas: mechanical equipment/automation or software/electronics/ engineering/supply chain/ manufacturing/biology/chemistry.5 or more years of experience in Project Management capacity within a regulated manufacturing industry with demonstrated leadership of cross-functional project teams and an ability execute high visibility projects with high expectationsFamiliarity with ISO, FDA and other regulatory standards.Knowledge of Project Management Best Practices including PMI Methods, Scrum, and Agile; PMI PMP Certification preferredProven ability to deliver complex, high impact projects in an ever-changing business environment; identify & implement best practices; perform with high levels of ambiguity and complexity.Comfort with communicating and presenting to all levels of the business and to all global regions.Ability to communicate clearly and effectively, both verbally and in writing.Who we areWhatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!Cytiva is a 3.3 billion USD global life sciences leader with nearly 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
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