Operations Engineer

Associate Director I Therapeutics I Head of DE&I at Skills Alliance Essential Functions Manage and track reliability‑related improvement initiatives across operations and engineering. Lead or support projects focused on reliability and process enhancement. Prepare, review, and approve change control and quality documentation for product or process changes. Ensure operational compliance with applicable U.S. and international regulatory standards and guidelines (e.g., FDA, EU, ISO, cGMP, etc.). Review validation protocols and reports (equipment, cleaning, and/or process) for assigned areas. Participate in internal and external audits and regulatory inspections. Serve as the quality contact for risk management activities, including FMEAs (Failure Modes and Effects Analyses). Investigate product deviations, out‑of‑specification results, and customer complaints to identify root causes and implement effective corrective and preventive actions. Analyze and report process and batch data to ensure compliance and identify areas for improvement. Develop, review, and revise Standard Operating Procedures (SOPs), batch records, and training materials in accordance with change management requirements. Adapt quickly to changing priorities in a fast‑paced, regulated environment. Work collaboratively across cross‑functional teams to identify and resolve issues efficiently. Requirements Bachelor’s degree in Life Sciences or Engineering (or related field). Minimum of 2 years of relevant experience in a regulated manufacturing environment; experience in pharmaceuticals, biotechnology, or medical devices preferred. Proven experience investigating deviations and implementing root cause analysis (RCA) using quality engineering tools such as 5‑Whys, Fishbone diagrams, TapRoot, or Kepner‑Tregoe. Strong understanding of applicable regulatory guidelines and validation principles for equipment, processes, and systems. Working knowledge of cGMP standards and quality management systems. Experience with statistical analysis tools; Lean or Six Sigma certification preferred. Excellent project management, problem‑solving, and organizational skills. Proficiency with Microsoft Office applications (Excel, PowerPoint, Word, SharePoint) and familiarity with MS Project and Visio. Seniority level: Associate Employment type: Full‑time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr Skills Alliance