Position Summary:We are seeking a detail-oriented and highly organized Investigation Specialist to join our Capital Projects Team supporting Engineering, Utilities, and Facilities in a solid dosage pharmaceutical manufacturing environment. The successful candidate will be responsible for leading and supporting investigations related to deviations, nonconformances, equipment and utility failures, and project execution issues, ensuring compliance with cGMP, regulatory requirements, and internal procedures. This role will work closely with cross-functional teams to identify root causes, implement corrective and preventive actions (CAPAs), and support the successful execution of capital projects impacting manufacturing, utilities, and facilities.Key Responsibilities:Lead and/or support investigations for deviations, equipment/utility failures, facility incidents, and project-related issues impacting manufacturing operations.Apply structured root cause analysis methodologies (e.g., 5 Whys, Fishbone, FMEA) to identify causes and recommend effective CAPAs.Ensure investigations are completed accurately, with proper documentation and within established timelines, in alignment with cGMP and regulatory requirements.Collaborate with Engineering, Facilities, Utilities, Operations, Maintenance, and Quality Assurance to gather data, review technical reports, and validate findings.Support change control processes for equipment, utilities, and facility modifications.Participate in capital project activities, including design review, equipment commissioning and qualification (C&Q), and start-up troubleshooting.Ensure proper documentation in compliance systems such as TrackWise or equivalent investigation management tools.Develop and maintain investigation templates, checklists, and best practices for the team.Monitor and report investigation trends, recurring issues, and systemic improvements to management.Support audits, regulatory inspections, and internal assessments by providing investigation documentation and justifications.Qualifications:Education:Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial), Facilities Management, or related technical discipline.Experience:Minimum 3–5 years of experience in pharmaceutical manufacturing, preferably in solid dosage operations.Strong background in engineering, utilities, or facilities systems (e.g., HVAC, compressed air, purified water, process equipment).Proven experience in investigation writing, root cause analysis, and CAPA development in a regulated environment.Technical Skills:Knowledge of cGMP, FDA, EMA, and other applicable regulatory requirements.Familiarity with TrackWise or other electronic investigation systems.Strong analytical, problem-solving, and technical writing skills.Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio, Project).Soft Skills:Strong interpersonal and communication skills to interact effectively across departments.Ability to manage multiple investigations/projects simultaneously under tight timelines.High attention to detail, organization, and documentation accuracy.Work Environment:On-site role within a regulated manufacturing facility.Interaction with production areas, utilities systems, engineering workshops, and project construction sites.Requires use of personal protective equipment (PPE) as applicable.