Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines.

RESPONSIBILITIES:

• Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations, activities, escalations and status of assigned tasks.
• Active participation on Contamination Control Strategy team meetings to provide input on activities, escalations and status of assigned tasks.
• Serve as Subject Matter Expert to lead Quality Risk Management exercises and author risk assessment reports. Responsible for implementation of identified actions.
• Serve as Subject Matter Expert to develop cleaning validation protocols, reports, executable instructions and implementation of additional data integrity requirements.
• Participate in the revision of the cleaning and contamination control strategy documentation records related to the manufacturing stages and steps.
• Lead and/or participate on triage activities to assess change control requirements.
• Issuance or support on change control generation.
• Issuance change control and present it in Change Control Board to pursue approval of the change.
• Review documentation associated to contamination control strategy and cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, sampling scheme, limit calculations, etc.).
• Revise SOPs related to cleaning program and contamination control strategy.
• Lead trainings activities provided to manufacturing operators.
• Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
• Comply with additional tasks requested by superviso

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum of 3–5 years of experience in the pharmaceutical or biotechnology industry, preferably in a quality or validation role.
• Strong knowledge of cGMPs, regulatory guidelines, and industry best practices related to cleaning validation and contamination control.
• Experience leading QRM exercises and authoring technical documentation.
• Familiarity with change control processes and documentation systems (e.g., VEEVA, Trackwise).
• Excellent written and verbal communication skills in English and Spanish.

Preferred Skills:

• Experience with Environmental Monitoring and Microbial Control Strategies.
• Proficiency with risk assessment tools such as FMEA.
• Previous experience working in cross-functional and project-based environments.