Validation Project Managers

Merck•Burlington, MA

1d•Hybrid

About The Position

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Requirements

Bachelor’s degree in Biology, Biochemistry, Chemistry or closely related field
At least two years of work experience in any occupation within the biotechnology or pharmaceutical industries
Demonstrated knowledge of extractables and leachable validation gained through at least two years of work experience
Demonstrated knowledge of project management and scheduling tools such as SalesForce, Smartsheet, SharePoint, and Microsoft 360 gained through at least two years of work experience
Demonstrated knowledge of quality assurance and Good Documentation Practices (OSHA, EHS, ISO9001) gained through at least two years of work experience
Demonstrated ability working with root cause analysis gained through at least two years of work experience

Responsibilities

Manage multiple customer projects – including bacterial retention testing, physical testing (compatibility, product bubble point/diffusion, and/or Vmax) and extractables and leachables – from order to final report, ensuring successful completion
Develop realistic project plans shared with customers, monitoring progress and adjusting timelines as necessary
Serve as the liaison between customers and validation service teams to coordinate activities effectively
Communicate proactively with customers and internal teams through timely updates, meetings, and discussions
Create, update, track, and close projects accurately and in a timely manner
Provide adequate level of technical support for standard services. Help customers define their needs and answering basic questions
Consult with VPMs, laboratory experts, and support teams for necessary project information and assistance
Assist with standard quotations based on customer needs and regulatory requirements while providing technical support