QA Contamination Control Program Lead

Johnson & Johnson•Gurabo, PR

14h•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for QA Contamination Control Program Lead to be located at Gurabo, PR. The QA Contamination Control Program Lead owns and governs the site’s holistic, risk‑based Contamination Control Program at Gurabo Site, developing, implementing, maintaining, and continuously improving the program in alignment with Johnson & Johnson Innovative Medicine requirements and regulatory expectations. The role provides microbiology and contamination‑control expertise across process, facility, utilities, materials, personnel, and monitoring; coordinates the multifunctional CCP team; and reports program performance and risks to Site Quality and Senior Leadership.

Requirements

A minimum of a bachelor’s degree in science with a major in Microbiology or Biology is required.
A minimum of six (6) years of experience in aseptic manufacturing, industrial microbiology, aseptic processing, contamination control, and/or sterility assurance.
Must have excellent ability to write in English and Spanish.
Ability to exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors.
This position requires availability for traveling, working irregular shifts, working extended hours, and might be required to work on holidays and weekends.

Nice To Haves

Advanced degree is preferred.
Cross‑functional leadership experience is preferred.
Training/qualification in GMP, Quality Risk Management, aseptic techniques/gowning, cleaning/disinfection/sterilization, and environmental monitoring per CCP training expectations is preferred.

Responsibilities

Leads the documented Site CCP, the lifecycle governance, and ensure annual effectiveness reviews and ongoing updates after excursions or impactful changes.
Coordinate the CCP Team (QA, QC, Manufacturing/Operations, MSAT/DPDS, Engineering/Facilities, Supply Chain, Microbiology) to develop and harmonize standards, specifications, protocols, and monitoring plans under the CCP.
Participates in the review of documents associated with the aseptic process.
Leads a comprehensive process flow (including suppliers/service providers), identify hazards, assess risks, and define critical control points (CCPs) with rationales and monitoring strategies.
Ensure controls across design, premises/equipment, personnel (training, hygiene, gowning), utilities, raw materials, packaging, vendor oversight, validation, cleaning/disinfection/sterilization, and environmental/ utility/ personnel/product monitoring are documented, effective, and complementary.
Partners/participates with other functions (i.e., MSAT, Microbiology, Operations) to develop training related to Contamination Control.
Embed CCP elements into the site QMS (change control, qualification/validation, training, NC/RCA/CAPA, supplier/material controls, pest control), ensuring data integrity and linkage to QSMR.
Ensure the aseptic techniques, cleaning and sanitization validations for clean rooms, HEPA Filter and gowning process are adequate and effective.
Actively participate in CCP governance and Environmental Review Committee; present state‑of‑control, risks, and improvement plans to Site Leadership and QSMR.
Design and evaluate trend leading & lagging indicators and KPIs; and respond to adverse trends or excursions; drive RCA/CAPA and verify effectiveness.
Evaluates and re-designs new methods, equipment and technology related to aseptic processing and environmental monitoring for manufacturing areas based on the scientifically sound approach.
Provide SME input for design transfer, New Product introduction (NPI), facility/equipment/utility design or modifications, and aseptic/industrial hygiene practices; align with Sterility Assurance as applicable.
Author/review/approve CCP‑related SOPs/WIs; maintain consistency with global standards
Provides scientific input and support actively the investigation process related to environmental monitoring, utilities and Microbiology and assure root cause and CAPAs are aligned with the opportunities identified.
Support internal and regulatory inspections (FDA, DEA, MCS, etc.) and corrective action processes and the implementation of quality processes.
Participate in change control boards; assess proposed changes for CCP impact before implementation and verify effectiveness after implementation.
Perform other duties as required by the team to support QA Unit activities.
Complies with the principles of conduct as expressed in our company Credo during all work-related activities.
Ensures a safe environment according to current Safety Policies and Procedures. Inform and act immediately if any unsafe situation is detected.
Actively participates in projects, programs, safety/environmental and training, GMP’s and other activities as required and/or special activities that the Company promotes to foster employee involvement and their professional development/growth.
Ensures knowledge in current systems such as but not limited to Documentations System and Investigation System.