Position Summary

The Sr. Contamination Control / Cleaning Subject Matter Expert (SME) will lead contamination control, cleaning validation, and disinfection program remediation activities within GMP-regulated pharmaceutical, biotechnology, and aseptic manufacturing environments. The individual will be responsible for assessing existing contamination control strategies, identifying compliance gaps, updating cleaning and disinfection programs, and implementing corrective actions to ensure alignment with current GMP requirements and regulatory expectations

. Key Responsibiliti esConduct comprehensive gap assessments of existing contamination control, cleaning, and disinfection programs against current GMP regulations, industry standards, and regulatory guidanc e.Evaluate cleanroom cleaning and disinfection practices for classified and controlled manufacturing area s.Review and update disinfectant qualification and challenge programs to ensure effectiveness against relevant environmental isolates and contaminant s.Develop and implement revised cleaning validation strategies, procedures, and protocol s.Assess disinfectant efficacy studies, contact surface requirements, residence time evaluations, and rotation program s.Revise SOPs and work instructions related to routine cleaning, disinfection, and contamination control practice s.Ensure cleaning procedures for classified environments align with aseptic processing and contamination control requirement s.Lead investigations related to cleaning, environmental monitoring, contamination events, and disinfection failure s.Develop phased remediation and corrective action plans to address identified compliance gap s.Coordinate implementation of corrective and preventive actions (CAPA) associated with contamination control and cleaning processe s.Support qualification and validation activities associated with cleaning agents, disinfectants, and cleaning processe s.Collaborate with Quality Assurance, Manufacturing, Validation, Microbiology, and Regulatory Affairs teams to ensure successful program implementatio n.Provide technical guidance and training to operational teams on contamination control best practice s.Support regulatory inspections, audits, and responses related to contamination control and cleaning validation program s.Monitor program effectiveness and establish continuous improvement initiatives to maintain GMP complianc

e. Contamination Control & Cleaning Program Remediat ionDocumented contamination control and cleaning program assessme nt.Comprehensive gap assessment report identifying compliance deficienci es.Revised cleaning procedures for classified and controlled manufacturing are as.Updated disinfectant challenge and efficacy qualification progr am.Revised disinfectant challenge procedures, including contact surface and residence time requiremen ts.Phased corrective action and remediation pl an.Implementation and verification of corrective actio ns.Updated cleaning validation documentation and supporting protoco ls.Training materials and personnel qualification recor ds.Final remediation summary report demonstrating GMP compliance improvemen

ts. Required Qualificat ionsBachelor's or Master's degree in Microbiology, Biology, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, or related discipl ine.8+ years of experience in contamination control, microbiology, cleaning validation, or quality systems within pharmaceutical, biotechnology, vaccine, or sterile manufacturing environme nts.Strong knowledge of GMP regulations, Annex 1, FDA, EMA, MHRA, and ICH guideli nes.Experience with cleanroom operations, environmental monitoring programs, and aseptic manufacturing proces ses.Expertise in disinfectant qualification, efficacy studies, cleaning validation, and contamination control strateg ies.Proven experience leading remediation and compliance improvement initiati ves.Excellent technical writing, investigation, and project management ski

lls. Preferred Qualifica tionsExperience supporting regulatory inspections and remediation prog rams.Knowledge of risk-based contamination control strategies and modern Annex 1 requirem ents.Experience in sterile manufacturing, biologics, cell & gene therapy, or vaccine production facili ties.Certification or specialized training in contamination control, microbiology, or quality systems is prefe

rred.