Manufacturing Specialist

Manufacturing Process Owner – Pharmaceutical Operations & Process ExcellenceLocation: East of Puerto Rico (Open only to Puerto Rico Residents)Work Schedule: Onsite | Administrative ShiftsFlexibility: Availability to cover alternate shifts and work overtime based on business needsEmployment Type: Contract OpportunityPosition SummaryOur client is seeking an experienced Manufacturing Process Owner to provide technical and operational support within a highly regulated pharmaceutical, biopharmaceutical, biotechnology, or medical device manufacturing environment.The selected professional will serve as a key process resource supporting GMP manufacturing operations, quality systems, process performance, deviations, CAPA, investigations, Change Control, process validation, manufacturing documentation, training, and New Product Introductions (NPI). The role requires strong analytical and troubleshooting capabilities and the ability to work effectively with cross-functional teams.Key ResponsibilitiesServe as a document owner for manufacturing procedures, ensuring documentation remains aligned with current operations, cGMP, and applicable regulatory requirements.Support and own Change Control activities, including assisting manufacturing change owners with CCRB packages impacting manufacturing processes.Evaluate process performance through manufacturing floor observations, data review, and process monitoring.Manage and support deviations and non-conformances, including assessments, investigations, Root Cause Analysis (RCA), corrective actions, and timely closure.Support CAPA management and continuous improvement activities.Ensure Electronic Batch Records (EBR) remain aligned with current manufacturing processes and support related training activities.Provide technical troubleshooting and process support for manufacturing equipment, automation systems, and process technologies.Support process validation activities, including protocols, execution, data analysis, and documentation.Participate in New Product Introductions, process improvements, and manufacturing initiatives.Develop and maintain technical documentation and training materials as required.Collaborate with Manufacturing, Quality, Engineering, Validation, Process Development, Automation, and other cross-functional teams to resolve issues and support site priorities.Apply Lean Manufacturing, Lean Six Sigma, Kaizen, or Continuous Improvement methodologies to improve process performance and operational reliability.Preferred QualificationsBachelor’s degree in Engineering is highly preferred.Experience in pharmaceutical, biopharmaceutical, biotechnology, or medical device manufacturing.Strong knowledge of GMP manufacturing operations and regulatory requirements.Hands-on experience managing deviations, including deviation assessments and the complete lifecycle from initiation through closure.Experience with TrackWise.Experience with CAPA, investigations, process validation, Change Control, and RCA.Knowledge of Veeva Vault (CDOCs) or similar document management platforms.Experience using Smartsheet or similar project management tools.Detailed understanding of bioprocessing unit operations.Experience with manufacturing equipment, automation systems, and process technologies.Strong technical writing, analytical, troubleshooting, organizational, and communication skills.Ability to effectively collaborate and communicate with cross-functional and technical teams.Basic knowledge of project management and process monitoring.Experience applying Lean Manufacturing, Lean Six Sigma, Kaizen, or Continuous Improvement methodologies.Education & ExperienceBachelor’s degree + minimum 4 years of Manufacturing Operations experience within the pharmaceutical, biopharmaceutical, biotechnology, or medical device industry.A Bachelor’s degree in Engineering is highly preferred.Ideal Profile: A hands-on manufacturing professional who combines process ownership, GMP expertise, quality systems knowledge, technical troubleshooting, and continuous improvement to drive reliable and compliant manufacturing operations.