Validation Laboratory Specialist

Sartorius Stedim•Yauco, PR

1d•Onsite

About The Position

The Validation Specialist will be responsible for leading, planning and executing validation activities in accordance with customer requirements defined in validation protocols considering established internal quality standards and regulatory guidelines. This role goes beyond execution, serving as a technical leader for lab technicians, in customer interactions, audit readiness and inspections, technical investigations and problem-solving initiatives. The position plays a critical role in ensuring data integrity, regulatory compliance, and patient safety through validated processes and systems. The holder of this position will be involved in the organization of supplies, planning and execution of maintenance efforts regarding the laboratory, test equipment, accessories and media (incl. documentation). In addition to hands-on testing, this position will contribute to laboratory operations, data integrity, and continuous improvement initiatives, supporting both project delivery and regulatory compliance.

Requirements

Bachelor's degree in life sciences or related fields
Technical expertise e.g. experienced lab technician, lab research or publications
Knowledge in cGMP, cGDP and cGLP
Be proficient in Microsoft Office applications (Word, Excel, PowerPoint)
Bilingual with good communication skills in Spanish and English (writing, reading and speaking)
Detail-oriented with strong organizational and time management skills
Team-oriented, engaging, and positive attitude towards internal and external stakeholders
Customer service-oriented
Desire and willingness to learn
Pro-active and a self-starter

Nice To Haves

Masters is preferred
Experience in product formulation is preferred

Responsibilities

Plan, lead, and execute validation studies, tests, and protocols in accordance with regulatory and customer requirements.
Perform relevant calculations and dilutions for analysis of data to be delivered to customer.
Analyze and interpret data to support validation studies and customer deliverables in defined timeline.
Prepare, review, and approve validation data, including customer protocols, final reports, forms and SOPs.
Lead, supervise and review equipment validations (IQ, OQ, PQ) executed by contractor services.
Lead validation lifecycle activities including risk assessment, and final reporting with Quality.
Implement process improvements and best practices keeping regulatory compliance
Consistently provide strategic input during collaborative sales meetings.
Interact with customers, including leading or supporting technical discussions and meetings.
Support and lead audits.
Lead and execute testing following SOP`s and regulatory guidance for customer products.
Own and manage the laboratory equipment maintenance program.
Manage contractors that provide third-party service to the laboratory.
Evaluate safety requirements for lab executions and manage applicable safety protocols.
Manage and own Laboratory inventory for equipment, reagents, consumables and customer products.
Collaborate with project managers in different regions across the globe and internal stakeholders.
Analize and recommend customer test approaches for validation studies in collaboration with project management.
Manage laboratory information and data reports with confidentiality.
Lead technical and regulatory investigations and corrective actions.
Lead special projects and collaborate with laboratories in other regions/ countries.
Lead technical training to new employees and customers when required.
Create technical documentation to be used with sales and customers.
Have adherence to customer project schedules and timelines within electronic planning tools.
Manage customer and project management expectations.
Participate and/or lead global meetings when assigned by management.
Always have adherence to company core values.
Flexibility is key for business success; the employee should be willing to assist with other duties as needed by the organization and/or management.