Principal ObjectiveProvide operational, scientific, and compliance support to Sterile and Non-Sterile Manufacturing. Own and execute manufacturing investigations (QE, NTR, NOE), CAPA, procedure development/revision, and process-validation documentation. Adhere to all Security, Environmental Health & Safety (EHS), and current Good Manufacturing Practices (cGMP) requirements.Major Duties & ResponsibilitiesInvestigations & CAPA: Ensure all QE, NTR, NOE, and CAPA are investigated, documented, and closed on time, applying effective root-cause and recurrence-prevention tools.Regulatory Support: Review and provide input to regulatory submissions within area of responsibility.Trending: Lead investigation/CAPA trend evaluations and drive systemic improvements.New Product Introduction (NPI): Participate in NPIs to define documentation, materials, training, and equipment modifications.Process Monitoring: Help establish process parameters and control limits; support statistical monitoring.Deviation Assessment: Support assessment of deviations and process-monitoring data.Optimization: Monitor ongoing processes to improve cycle time, productivity, equipment performance, yields, and quality.Technical Support: Recommend and implement process/equipment modifications; contribute to cost-reduction projects while ensuring cGMP compliance.Documentation: Write, evaluate, and revise manufacturing documentation (e.g., SOPs, MBRs); assist with training on scientific/technical process aspects.Validation: Assist in generating and executing validation protocols and reports (sterile and non-sterile).Inspections: Participate in regulatory inspections as needed.Troubleshooting: Partner with area leadership to resolve process/equipment issues affecting yield, cycle time, quality, or productivity.Continuous Improvement: Provide alternatives and recommendations to maximize process and equipment performance.EHS & Compliance: Contribute to Environmental Regulatory/Compliance permits and Process Safety Hazard evaluations.Culture & Teamwork: Model the company’s Core Behaviors; facilitate collaboration across functions.Site Initiatives: Support site initiatives and perform other duties based on business needs.Minimum QualificationsBachelor’s degree in Engineering, Life Sciences, or related discipline.Demonstrated experience in pharmaceutical manufacturing (sterile and/or non-sterile).Hands-on ownership of QE/NTR/NOE, CAPA, and process validation documentation under cGMP.Strong technical writing and documentation skills (English; Spanish a plus).Proficiency with MS Office and familiarity with eQMS/EDMS tools for deviations, CAPA, and document control.Proven ability to collaborate cross-functionally (Manufacturing, Quality, Engineering, EHS).Preferred QualificationsExperience supporting regulatory submissions and regulatory inspections.Background in process monitoring/CPK, trend analysis, and risk assessment (e.g., 5-Why, Fishbone, FMEA/pFMEA).Exposure to NPI in GMP environments and to equipment/process troubleshooting.Experience training operators/technicians on SOPs, MBRs, or validation practices.Work Environment & ComplianceOn-site role in a GMP-regulated facility.Must follow Security, EHS, and cGMP practices at all times and maintain inspection-ready documentation.
