Thermo Fisher Scientific

Scientist III - Continuous Process Verification

Thermo Fisher Scientific$85K — $110K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific or engineering field
  • 5+ years experience in GMP regulated Biologics/Pharma Industry
  • Experience in process validation
  • Strong foundation in scientific principles and practices
  • Excellent communication skills
  • Ability to work independently and in teams
  • Proficiency in statistical analysis software (e.g., JMP)

Responsibilities

  • Perform process validation support with a focus on Continued Process Verification (CPV)
  • Establish and implement global CPV initiatives and practices
  • Act as primary biostatistician for Process Engineering and DoE studies
  • Manage scope, schedule, and reporting of CPV program activities
  • Participate in Customer and Regulatory Audits
  • Draft, review, and approve CPV plans, reports, and APQRs

Benefits

  • Comprehensive health and wellness programs
  • Retirement savings plan with company match
  • Paid time off and holiday benefits
  • Professional development and training opportunities
  • Employee discount programs
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Location/Division Specific Information

Thermo Fisher Scientific's facility in St. Louis, MO, offers comprehensive services for developing and manufacturing biologic drugs. The 96,875-square-foot facility supports the entire process, from initial development to commercial production. It has extensive cell culture capabilities and can handle batch sizes from 100 grams to 20 kilograms using advanced single-use equipment.

The site is a leader in single-use technology, providing flexible options for scaling up production from 50 liters to 5,000 liters. The new 5,000-liter Dynadrive bioreactor, developed at the facility, showcases Thermo Fisher's expertise in biologics manufacturing and bioprocessing.

We are searching for a Continued Process Verification (CPV) Engineer III with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological and statistical input in the validation and continued process verification of manufacturing processes. A CPV Engineer 3 routinely supports the Manufacturing Sciences and Technology team as a technical owner of commercial customer programs in a manufacturing environment and will assist in defining and shaping Thermo Fisher Scientific's continued process verification. expert in statistics and data analysis. This role will collaborate internally with Process Engineers, Quality Assurance, and Regulatory. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.

Responsibilities:
  • Perform all functions associated with process validation support, with a specific focus on CPV
  • Establish global CPV initiatives and standard practices
  • Act as the primary biostatistician in supporting Process Engineering and Process Development DoE studies
  • Manage the scope, schedule, and reporting of CPV program activities
  • Participate in Customer and Regulatory Audits
  • Draft, review, and approve CPV plans, CPV reports, and APQRs


Requirements:
  • Bachelor's degree in a scientific field, preferably an engineering field
  • 5+ years of experience in the GMP regulated Biologics/Pharma Industry or equivalent (or master's degree + 2 years' experience or Ph.D.)
  • Experience with process validation
  • Strong foundation in general scientific practices, principles, and concepts
  • Excellent written and verbal communication skills
  • Ability to work independently and collaboratively as part of a team
  • Proficiency in statistical analysis software programs such as JMP
  • Proficient in Microsoft Word and Excel


About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

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