Validation Laboratory Expert - On site - Yauco, PR

The Validation Lab Expert is a key technical leader within the Confidence Validation Laboratory. This role demands a high level of scientific knowledge and experience in conducting and troubleshooting microbiological and physiochemical tests. The Validation Lab Expert will interpret results, ensure data integrity, and contribute to the continuous improvement of laboratory processes.

What you will accomplish together with us:

Ability to handle microbial cultures and perform test that involve live cultures.

Serve as the technical scientist (SME) for microbiological and physiochemical tests.

Perform, interpret, and troubleshoot complex laboratory tests.

Analyze results, prepare reports, and present findings to management.

Use statistical tools to present data and report outs to management.

Ensure data integrity ALCOA + and compliance with all relevant regulations (GMP, ISO, GDP).

Develop and validate new test methods.

Oversee and participate in the training of laboratory personnel.

Conduct/lead lab investigations and quality actions.

Support and participate in audits and regulatory inspections.

Contribute to the development and continuous improvement of laboratory processes.

Lead and participate in problem-solving and root cause analysis initiatives.

Maintain a safe and organized work environment.

Oversee laboratory inventory and resources.

Collaborate with stakeholders (PM, Customers, other) to achieve project goals.

Participate in and lead technical calls and meetings.

Support customer communication and technical inquiries.

Proactively drive global harmonization and optimization initiatives.

Represent the laboratory in the global Confidence® network.

What will convince us:

Bachelor’s degree in Biology, Microbiology, Chemistry or related field. Master’s degree is preferred.

5+ years working experience in a regulated industry, preferably in pharmaceuticals. Experience in Laboratory environment is preferred.

5+ years working experience with GMP, GDP, GLP, and ISO requirements.

Bilingual (Spanish & English) is required.

Strong understanding of mathematics, scientific principles and laboratory techniques.

Proficient in CAPA, root cause analysis, risk assessment, and statistical analysis.

Scientific knowledge in troubleshooting laboratory equipment and assays.

Excellent technical writing and scientific communication skills.

Ability to work independently and as part of a team.

Proficient in Microsoft Office applications and relevant software.

Experience working in a global environment is a plus.

Excellent written and verbal communication skills, including the ability to explain technical information to both technical and non-technical audiences.

Availability to travel (National and International).

What We Offer:

Paid vacation and sick leave

14 paid holidays annually

Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees.

We offer an open-office concept, a spacious outdoor area, conference areas and a development center.

Medical, Dental and Vision insurance along with Company Retirement Plan

On-site cafeteria and coffee shop

On-site occupational health offices including Laboratory Services & Doctors

Physical Demands:

Ability to work in a laboratory environment.

Regularly required to sit, stand, and walk.

Reasonability for Safety risks of others:

Comply with OSHA Standards, Rules, Regulations and Sartorius Stedim Filters, Inc. Safety Programs which are applicable for his/her own actions and conduct.

Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.

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.

Please view equal employment opportunity posters provided by OFCCP here.

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 .

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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.

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