As the Validation Laboratory Specialist, you will be accountable for meticulously planning and executing validation tests in accordance with customer demands and internal quality and customer protocols. This encompasses the organization of laboratory supplies, overseeing equipment maintenance, and ensuring compliance with all safety regulations. The Validation Laboratory Specialist will play a key role in identifying and resolving quality issues, supporting continuous improvement initiatives, and collaborating effectively with internal and external

As the Validation Laboratory Specialist, you will contribute to the accomplishment of different task of the laboratory, integrating his knowledge, experience and execution in day-to-day activities. This role requires a level of multitasking and holistic overview of the business to achieve business goals.

Environmental Health and Safety (EHS) Regulations, Occupational Health and Safety Administration System (OSHA) Regulations. GMP, ISO, GDP.

What you will accomplish together with us:

• Plan and execute validation tests as per protocols and procedures.

• Operate, maintain, and troubleshoot laboratory equipment.

• Ensure compliance with safety protocols (OSHA, GMP, GDP) and maintain a clean and organized work environment.

• Note: Flexibility is key for business success; the employee should be willing to assist with other duties as needed by the organization and/or management.

• Identify and organize relevant tasks and materials.

• Collaborate with project management and stakeholders.

• Define test approaches and support validation documentation.

• Manage laboratory information and data reports.

• Report quality events and support investigations.

• Support continuous improvement and special projects.

• Report inadequate processes/equipment and support corrective actions.

• Draft, revise, and train on SOPs and technical documentation.

• Support compliance with internal quality regulations.

• Promote a team environment and assist colleagues.

• Adhere to project schedules.

• Participate in audits and provide regulatory support.

• Participate in and lead problem-solving initiatives.

• Participate in and lead global meetings.

• Adhere to company core values.

What will convince us:

• Bachelor’s degree in life sciences or related field.

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

• Bilingual (fluent in English and Spanish is required).

• Minimum of 3 years of experience in a similar position working in pharma, biopharma or medical device. Experience in laboratory environment is preferred.

• Technical expertise in laboratory procedures (execution and modification).

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

• Experience with data analysis and trending.

• Knowledge of GMP, GDP, GLP and ALCOA +.

• Proficient in Microsoft Office applications.

• Excellent communication (verbal and written) and scientific writing skills.

• Critical thinking, problem-solving abilities and continuous improvements.

• Ability to multitask and work independently.

• Flexibility in working hours. May include change of working hours, extended shift or weekends.

• Ability to work in a global environment and network effectively.

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

• Presentation and training skills.

• Knowledge of regulatory requirements and scientific literature.

• Ability to design and oversee experiments.

• Experience with method validation and ensuring compliance with data integrity.

• Ensure laboratory inventory and resources are always available.

• Identification with our core values: Sustainability, Openness, Enjoyment

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

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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. www.sartorius.com/careers