• Virus Clearance & Filter Validation Project Manager - Onsite - Marlborough, MA

Sartorius•Marlborough, MA

8h•$90,000 - $135,000•Onsite

About The Position

The Virus Clearance & Filter Validation Project Manager for the Americas plays a key role in coordinating Virus Clearance and Filter Validation projects for our newly established site in Marlborough, MA. The role ensures compliant, high quality project delivery while partnering closely with customers and internal experts. What you will accomplish together with us: Coordination of validation projects in line with customer and regulatory requirements (e.g., FDA, EMA, WHO) Project scoping for Virus Clearance Studies and Filter Validation projects Technical consultancy and risk assessment aligned with Confidence Validation Services methodologies Monitoring and tracking of project progress using designated tools, including preparation of monthly reports for management Promotion of Validation Services offerings to support business growth Support of regulatory workshop preparation and customer guidance regarding regulatory frameworks Contribution to consumables business growth in collaboration with Application Specialists Cross-functional collaboration to ensure efficient operations within the Virus Clearance Services team and related departments Participation in customer visits, workshops, and virtual meetings to identify needs and shape tailored solutions Perform other duties as assigned What will convince us: Bachelor’s degree in a relevant scientific discipline (Master’s or higher degree advantageous) Relevant certifications (e.g., PMP) is a plus 3 years of experience in project or program management demonstrating delivery of complex initiatives Background in viral spiking/clearance studies and/or filter validation projects is advantageous Understanding of pharmaceutical manufacturing processes, regulatory compliance, and quality requirements Sound scientific and technical expertise, especially in downstream processing; experience in cell and/or virus culture, cell-based assays, or chromatography is beneficial Familiarity with GxP and virus clearance regulatory guidelines (e.g., ICH Q5A, GLP Statutory Instrument 3106) Strong strategic thinking and analytical mindset with the ability to align project objectives with organizational goals Excellent verbal and written communication and effective networking abilities Customer-focused, service-oriented mindset Strong organizational skills and commitment to continuous improvement National and international travel as required Bilingual in Spanish a plus Alignment with our core values: Sustainability, Openness, Enjoyment Compensation for this position will be a base salary between $90,000 and $135,000 depending upon experience and qualifications. What We Offer As a growing global life science company, with our stock listed on the German DAX and TecDAX , Sartorius offers a wide range of benefits: Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network” Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs. Intelligent Working Environment: Working in smart buildings with the latest technology and equipment. Retirement Savings Plan: 401 k (with generous company match) Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability or based on status in any other protected group of class. Please view equal employment opportunity posters provided by OFCCP here. E-Verify Participation Info E-Verify Workers Rights Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application. We look forward to receiving your application. www.sartorius.com/career If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at [email protected] Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability, or based on status in any other protected group of class. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at [email protected] About Sartorius Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers to our Candidate Portal and thank you for your interest in working and growing with us. We look forward to receiving your application. You can check the status anytime in this portal. Here you will find the best application tips from our HR team. Information on the application process can also be found in this video and under FAQ & Contact. In this brochure you will learn more about us as an employer and your career with us. For further insights, please visit the Sartorius Blog and our career website. Set up your personal Job Alert now and never miss an opportunity to apply for a job that suits you. Please note that you will receive an initial confirmation message. You'll need to confirm your selection to start receiving job alerts tailored to your preferences.

Requirements

Bachelor’s degree in a relevant scientific discipline (Master’s or higher degree advantageous)
3 years of experience in project or program management demonstrating delivery of complex initiatives
Understanding of pharmaceutical manufacturing processes, regulatory compliance, and quality requirements
Sound scientific and technical expertise, especially in downstream processing; experience in cell and/or virus culture, cell-based assays, or chromatography is beneficial
Familiarity with GxP and virus clearance regulatory guidelines (e.g., ICH Q5A, GLP Statutory Instrument 3106)
Strong strategic thinking and analytical mindset with the ability to align project objectives with organizational goals
Excellent verbal and written communication and effective networking abilities
Customer-focused, service-oriented mindset
Strong organizational skills and commitment to continuous improvement
National and international travel as required

Nice To Haves

Relevant certifications (e.g., PMP) is a plus
Background in viral spiking/clearance studies and/or filter validation projects is advantageous
Bilingual in Spanish a plus
Alignment with our core values: Sustainability, Openness, Enjoyment

Responsibilities

Coordination of validation projects in line with customer and regulatory requirements (e.g., FDA, EMA, WHO)
Project scoping for Virus Clearance Studies and Filter Validation projects
Technical consultancy and risk assessment aligned with Confidence Validation Services methodologies
Monitoring and tracking of project progress using designated tools, including preparation of monthly reports for management
Promotion of Validation Services offerings to support business growth
Support of regulatory workshop preparation and customer guidance regarding regulatory frameworks
Contribution to consumables business growth in collaboration with Application Specialists
Cross-functional collaboration to ensure efficient operations within the Virus Clearance Services team and related departments
Participation in customer visits, workshops, and virtual meetings to identify needs and shape tailored solutions
Perform other duties as assigned

Benefits

Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings
Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.
Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate
Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service