Qrm/Contamination Control Strategy/Cleaning Validation Support

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 Requirements 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.