Validation Laboratory Specialist- On Site- Yauco, PR

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:

• Bachelors 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 219000 square meters our campus is home for more than 1000 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.

Please view equal employment opportunity posters provided by OFCCP here

E-Verify Participation Info

E-Verify Workers Rights

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.
Experience:

Unclear Seniority